Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00122369
• Collaborator: United States Department of Defense (U.S. Fed)
• Enrollment: 240
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

Percutaneous large core image-guided breast biopsy is a well established tool in diagnosing breast cancer, but the associated anxiety and pain can tax the coping mechanism of even well functioning individuals. Unabated stress during an invasive procedure not only interferes with smooth progression of the ongoing procedure, but can also have deleterious effects when patients need additional procedures and dread recurrent medical traumatization. The long-term objective of this research is to provide patients with a simple coping strategy at the vulnerable time of large core biopsy in the hope that this behavioral intervention will carry over to recovery and future medical procedures. In the largest prospective randomized study of its kind, the researchers showed that a self-hypnotic intervention during percutaneous, image-guided vascular and renal interventions resulted in less pain and anxiety, greater hemodynamic stability, and fewer procedure interruptions. The positive effects of the short initial hypnotic intervention, which was structured in the procedure room, became more pronounced the longer the procedure lasted and carried over into the immediate post-procedure recovery. The investigators therefore challenge the current paradigms that long-lasting effects require intensive presurgical preparation.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Anxiety; Pain	Behavioral: Self-hypnotic Relaxation; Behavioral: Empathic Attention	Phase 2

Detailed Description

Large core image-guided breast biopsy is a well established tool for diagnosing breast cancer. Using ultrasound or X-ray guidance, a large hollow needle is inserted through the skin into the breast and abnormal tissue is removed for diagnosis. Although this procedure is much less invasive than open surgery, it can induce pain and anxiety that can tax the coping mechanism of even the highest functioning individuals. Unrelieved stress during a medical procedure not only interferes with smooth progression of the ongoing procedure, but can also have deleterious effects when patients need additional procedures and feel dread in anticipation. The long-term objective of this research is to provide patients with a simple coping strategy at the time of large core biopsy, when they need it most. The hope is that this newly learned ability to handle distress will carry over to recovery and to future medical procedures. In a prior clinical trial (Lancet 2000:335:1486-1489), the largest prospective randomized study of its kind, the researchers showed that a self-hypnotic intervention during image-guided interventions of the blood vessels and the kidneys resulted in less pain and anxiety, fewer worrisome increases and decreases of blood pressure and heart rate, and fewer procedure interruptions. The positive effects of the short initial hypnotic intervention, which was structured in the procedure room, became more pronounced the longer the procedure lasted and carried over into the immediate post-procedure recovery. Based on these past findings, the researchers therefore predict to show evidence contrary to the current thinking that long-lasting effects require intensive presurgical preparation.

The researchers propose to pursue three interrelated specific aims:

• (Aim 1): Determine the acute effects of self-hypnotic relaxation on pain and anxiety. Strictly defined methods of self-hypnotic relaxation (Group I), will be tested against empathic attention (Group II) and the routine standard of care (Group III) in a prospective randomized study with 240 patients undergoing large core breast biopsy. The impact of the treatment will be validated by comparing during the procedure among groups subjective measures of pain and anxiety as well as objective physiologic indicators of pain and anxiety (frequency of significant increases in heart rate and blood pressure).

• (Aim 2): Determine the delayed effects of self-hypnotic relaxation. Patients' levels of pain, anxiety, and stress will be recorded through days 1-5 after the biopsy and compared among groups. Stress levels measurements will be based on an objective test (the amount of the stress hormone cortisol in the patient's saliva).

• (Aim 3): Determine the effect of the initial self-hypnotic relaxation on distress with upcoming subsequent surgery in women with proven breast cancer. When patients have to return for surgery because their biopsy revealed malignant cells, they will be given questionnaires assessing their degree of perceived stress , anxiety, and preoccupation with their upcoming surgery. Comparison among groups will show the durability of the initial hypnotic intervention.

The researchers hypothesize that:

• Self-hypnotic relaxation reduces pain and anxiety during large core breast biopsy

• Self-hypnotic relaxation at the time of biopsy reduces post-biopsy stress

• Teaching patients coping skills at the critical time of the breast biopsy reduces the patients' distress with upcoming breast surgery.

Upon completion, a short periprocedural self-hypnotic intervention will be validated by rigorous and practical assessment in 240 patients. The relative performance of self-hypnotic relaxation will be known compared to standard care and empathic controls in a well-characterized population of patients with a standardized biopsy wound. The durability of an intervention given at the earliest possible moment of breast cancer diagnosis will be established. This opens the way to future study designs addressing long-term effects on health behavior and psycho-physiologic phenomena.

Study Design

• Study Type: Interventional
• Actual Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Official Title: Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
• Study Start Date: Mar 1, 2002
• Actual Primary Completion Date: Mar 1, 2004
• Actual Study Completion Date: Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Self-hypnotic Relaxation A research assistant displayed defined behaviors of empathic attention and read to the patient a self-hypnotic relaxation script. Patients also received lidocaine as local anesthetic which is the standard care approach and not considered a unique intervention in terms of the trial.	Behavioral: Self-hypnotic Relaxation; A research assistant read to the patient a self-hypnotic relaxation script while displaying empathic attention.; Other Names: Comfort Talk® ; Behavioral: Empathic Attention; A research assistant displayed defined behaviors of empathic attention.; Other Names: Empathy Advanced Rapport Skills
No Intervention: Standard Care Patients received the routine standard treatment which included application of lidocaine as local anesthetic. This is not considered a unique intervention in terms of the trial. Omitting local anesthetic actually would have been an intervention deviating from routine care.
Active Comparator: Empathic Attention A research assistant displayed defined behaviors of empathic attention. Patients also received lidocaine as local anesthetic which is the standard care approach and not considered a unique intervention in terms of the trial.	Behavioral: Empathic Attention; A research assistant displayed defined behaviors of empathic attention.; Other Names: Empathy Advanced Rapport Skills

Outcome Measures

Primary Outcome Measures

1. Anxiety Ratings at Specified Time Point During the Procedure [0 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety to 10=worst possible anxiety. Patients self-reported anxiety at the beginning (time 0), every 10 minutes, and at the end of their biopsy procedure on a 0-10 numeric verbal anxiety scale (0=no anxiety at all, 10=worst possible anxiety). Participants were followed for the duration of the biopsy procedure, an average of 43 min.

2. Anxiety Ratings at Specified Time Point During the Procedure [10 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

3. Anxiety Ratings at Specified Time Point During the Procedure [20 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

4. Anxiety Ratings at Specified Time Point During the Procedure [30 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

5. Anxiety Ratings at Specified Time Point During the Procedure [40 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

6. Anxiety Ratings at Specified Time Point During the Procedure [50 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

7. Anxiety Ratings at Specified Time Point During the Procedure [60 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

8. Anxiety Ratings at Specified Time Point During the Procedure [70 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

9. Anxiety Ratings at Specified Time Point During the Procedure [80 min]

   Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

10. Anxiety Ratings at Specified Time Point During the Procedure [90 min]

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

11. Anxiety Ratings at Specified Time Point During the Procedure [100 min]

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

12. Anxiety Ratings at Specified Time Point During the Procedure [110 min]

    Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety

13. Time Trends of Anxiety Experience [0-110 min]

    Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported anxiety scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with anxiety scores reported between 0=no anxiety and 10=worst possible anxiety. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.

14. Pain Ratings at Specified Time Point During the Procedure [0 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

15. Pain Ratings at Specified Time Point During the Procedure [10 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

16. Pain Ratings at Specified Time Point During the Procedure [20 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

17. Pain Ratings at Specified Time Point During the Procedure [30 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

18. Pain Ratings at Specified Time Point During the Procedure [40 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

19. Pain Ratings at Specified Time Point During the Procedure [50 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

20. Pain Ratings at Specified Time Point During the Procedure [60 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

21. Pain Ratings at Specified Time Point During the Procedure [70 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

22. Pain Ratings at Specified Time Point During the Procedure [80 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

23. Pain Ratings at Specified Time Point During the Procedure [90 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

24. Pain Ratings at Specified Time Point During the Procedure [100 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

25. Pain Ratings at Specified Time Point During the Procedure [110 min]

    Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain

26. Time Trends of Pain Experience [0-110 min]

    Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported pain scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with pain scores reported between 0=no pain, and 10=worst possible pain. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.

Secondary Outcome Measures

1. Salivary Cortisol Secretion [Patients were followed for the 5 days following their breast biopsy]

   Secretion of cortisol over time is customarily described in terms of a slope with the time of day of cortisol measurement as the x variable and the natural logarithm of the measured cortisol concentration as the y variable. Cortisol slope is expressed as the natural logarithm of cortisol (micrograms per deciliter) per hour, with 1g/dL corresponding to 27.8 nmol/L. In general, greater negative slopes (with steeper decreases from high morning values to low evening values) are considered better adapted and healthier than flatter (less negative) slopes.

2. Impact of Event Scale (IES-15) [Patients were followed for up to 3 weeks after their biopsy until the time of their surgery]

   The IES is a measure of subjective distress for any specific life event. This 15-item self-report instrument is used to assess experiences of intrusive thoughts (Intrusion subscale) and attempts to consciously avoid such experiences (Avoidance subscale) that are commonly associated with subjective distress about life situations. Answers are given in four ratings from not at all (score 0) to often (score 5), with a possible TOTAL overall range of scores from zero to 75. ≥26 indicates moderate to severe distress) of women who at the time of return for breast surgery after their initial biopsy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients presenting for large core breast biopsy in the Radiology Department at the Beth Israel Deaconess Medical Center Boston.

Exclusion Criteria:

Patients are excluded if :

• They are unable to give informed consent, or pass screening for impaired mental function or psychosis.

• They are unable to hear or understand English.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center
• United States Department of Defense

Investigators

• Principal Investigator: Elvira V Lang, MD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elvira Lang, Former Associate Professor of Radiology, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT00122369
• Other Study ID Numbers: DAMD 17-01-1-0153; 2001P-001681
• First Posted: Jul 22, 2005
• Last Update Posted: Feb 28, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Elvira Lang, Former Associate Professor of Radiology, Beth Israel Deaconess Medical Center: Breast; Biopsy; Hypnosis; Relaxation; Anxiety; Pain; Medical and Surgical Procedures
• Additional relevant MeSH terms: Hypnotics and Sedatives

Study Results

Participant Flow

Recruitment Details	Between February 2002 and March 2004, 240 eligible patients were recruited and randomly assigned to treatments. Four patients (including the only male) withdrew after entering the biopsy suite before starting with the intervention in the Intervention Groups or data collection in the Standard Care Group.

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Period Title: Overall Study
STARTED	76	82	78
COMPLETED	76	82	78
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation	Total
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.	Total of all reporting groups
Overall Participants	76	82	78	236
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	69 90.8%	74 90.2%	73 93.6%	216 91.5%
>=65 years	7 9.2%	8 9.8%	5 6.4%	20 8.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.2 (13.4)	48.0 (13.22)	47.8 (13.7)	48.3 (13.4)
Sex: Female, Male (Count of Participants)
Female	76 100%	82 100%	78 100%	236 100%
Male	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	76 100%	82 100%	78 100%	236 100%

Outcome Measures

1. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety to 10=worst possible anxiety. Patients self-reported anxiety at the beginning (time 0), every 10 minutes, and at the end of their biopsy procedure on a 0-10 numeric verbal anxiety scale (0=no anxiety at all, 10=worst possible anxiety). Participants were followed for the duration of the biopsy procedure, an average of 43 min.
Time Frame	0 min

Outcome Measure Data

Analysis Population Description

Intention to Treat; patients on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	76	82	78
Median (Inter-Quartile Range) [units on a scale]	4.5	5	5

2. Secondary Outcome

Title	Salivary Cortisol Secretion
Description	Secretion of cortisol over time is customarily described in terms of a slope with the time of day of cortisol measurement as the x variable and the natural logarithm of the measured cortisol concentration as the y variable. Cortisol slope is expressed as the natural logarithm of cortisol (micrograms per deciliter) per hour, with 1g/dL corresponding to 27.8 nmol/L. In general, greater negative slopes (with steeper decreases from high morning values to low evening values) are considered better adapted and healthier than flatter (less negative) slopes.
Time Frame	Patients were followed for the 5 days following their breast biopsy

Outcome Measure Data

Analysis Population Description

Women learned their diagnosis between Day 1 and 6 (mean day 2.4). Analysis was truncated at day 5 when sufficient numbers of patients for meaningful analysis were available in each group: 16 in the "known malignant" group, 37 in the "known benign" group, and 73 in the "uncertain group" totaling 126 patients.

Arm/Group Title	Known Benign Disease	Known Malignant Disease	Uncertain Diagnosis
Arm/Group Description	Women who were diagnosed to have benign disease	Women who were diagnosed to have malignant disease	were in the "uncertain" diagnostic group, either because their result had not been communicated yet (n=54); their LCBB could not be performed for technical reasons and they were waiting for a surgical excision (n=14); or histology showed at risk lesions (n=4) or benign cells with surgery recommended for excision and final diagnosis (n=1).
Measure Participants	37	16	73
Mean (95% Confidence Interval) [ln (microgram/dL)/hr]	-0.154	-0.110	-0.092

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Self-Hypnotic Relaxation
	Comments	The impact of knowing or not knowing the diagnosis became so overwhelming and group composition with regard of whether and which result had been communicated changed daily in the post-biopsy follow-up, so that the originally planned analysis of the impact of Self-Hynotic Relaxation or Empathic Attention on cortisol measures became underpowered. Therefore we focused on the analysis of the impact of diagnosis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments	Bonferoni correction was made so that results with p<0.0167 are considered significant
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Empathic Attention, Self-Hypnotic Relaxation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.421
	Comments	Bonferoni correction was made so that results with p<0.0167 are considered significant.
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Empathic Attention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.138
	Comments	Bonferoni correction was made so that results with p<0.0167 are considered significant.
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Impact of Event Scale (IES-15)
Description	The IES is a measure of subjective distress for any specific life event. This 15-item self-report instrument is used to assess experiences of intrusive thoughts (Intrusion subscale) and attempts to consciously avoid such experiences (Avoidance subscale) that are commonly associated with subjective distress about life situations. Answers are given in four ratings from not at all (score 0) to often (score 5), with a possible TOTAL overall range of scores from zero to 75. ≥26 indicates moderate to severe distress) of women who at the time of return for breast surgery after their initial biopsy
Time Frame	Patients were followed for up to 3 weeks after their biopsy until the time of their surgery

Outcome Measure Data

Analysis Population Description

These 19 patients were the only ones who could be captured for their return to surgery after their initial biopsy.

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	7	4	8
Mean (Standard Deviation) [Scores on a Scale]	25 (10.7)	27 (13.7)	24 (15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Empathic Attention, Self-Hypnotic Relaxation
	Comments	The null-hypothesis was that there would be no difference among groups.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.56
	Comments
	Method	ANOVA
	Comments

4. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	10 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	76	81	77
Median (Inter-Quartile Range) [units on a scale]	4	4	4

5. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	20 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	76	81	75
Median (Inter-Quartile Range) [units on a scale]	4	4	3

6. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	30 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	70	72	66
Median (Inter-Quartile Range) [units on a scale]	4	4.5	4

7. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	40 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	59	57	52
Median (Inter-Quartile Range) [units on a scale]	5	5	4

8. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	50 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	42	45	39
Median (Inter-Quartile Range) [units on a scale]	6	4	3

9. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	60 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	32	31	26
Median (Inter-Quartile Range) [units on a scale]	5	4	2.5

10. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	70 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	23	23	20
Median (Inter-Quartile Range) [units on a scale]	5	3	2.5

11. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	80 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	15	12	8
Median (Inter-Quartile Range) [units on a scale]	5	4	3

12. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	90 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table (please note that the data in the hypnosis group encompass only 4 patients since the 5th patient did not indicate her anxiety level at that time point)

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	8	7	5
Median (Inter-Quartile Range) [units on a scale]	5	7	0.5

13. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	100 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	7	5	5
Median (Inter-Quartile Range) [units on a scale]	4	3	2

14. Primary Outcome

Title	Anxiety Ratings at Specified Time Point During the Procedure
Description	Self-reported anxiety on a scale of 0-10 with 0=no anxiety and 10=worst possible anxiety
Time Frame	110 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	4	2	1
Median (Inter-Quartile Range) [units on a scale]	4.5	2	5

15. Primary Outcome

Title	Time Trends of Anxiety Experience
Description	Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported anxiety scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with anxiety scores reported between 0=no anxiety and 10=worst possible anxiety. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.
Time Frame	0-110 min

Outcome Measure Data

Analysis Population Description

Intent to Treat; patients undergoing breast biopsy

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	76	82	78
Number [logit slopes]	0.18	-0.04	-0.27

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Ordinal regression
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Empathic Attention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.45
	Comments
	Method	Ordinal regression
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Self-Hypnotic Relaxation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Ordinal regression
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Empathic Attention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Proportional odds model
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Self-Hypnotic Relaxation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Proportional odds model
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Empathic Attention, Self-Hypnotic Relaxation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments
	Method	Proportional odds model
	Comments

16. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	0 min

Outcome Measure Data

Analysis Population Description

Intent to Treat; patients on procedure table. (Please note that the data in the empathy group encompass 81 data points since one patient did not indicate her pain level at that time point).

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	76	82	78
Median (Inter-Quartile Range) [units on a scale]	0	0	0

17. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	10 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	76	81	77
Median (Inter-Quartile Range) [units on a scale]	0	0	0

18. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	20 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	76	81	75
Median (Inter-Quartile Range) [units on a scale]	1	0	0

19. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	30 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	70	72	65
Median (Inter-Quartile Range) [units on a scale]	2	0	0

20. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	40 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	59	57	52
Median (Inter-Quartile Range) [units on a scale]	2	2	0

21. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	50 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	41	45	39
Median (Inter-Quartile Range) [units on a scale]	4	2	1

22. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	60 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	32	31	26
Median (Inter-Quartile Range) [units on a scale]	2.5	2	1

23. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	70 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	23	23	20
Median (Inter-Quartile Range) [units on a scale]	4	2	2

24. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	80 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	15	12	8
Median (Inter-Quartile Range) [units on a scale]	5	3.5	2.5

25. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	90 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table. (Please note that the data in the hypnosis group encompass 4 data points since one patient did not indicate her anxiety level at that time point).

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	8	7	5
Median (Inter-Quartile Range) [units on a scale]	5	2	1.5

26. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	100 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	7	5	5
Median (Inter-Quartile Range) [units on a scale]	9	2	2

27. Primary Outcome

Title	Pain Ratings at Specified Time Point During the Procedure
Description	Self-reported pain on a scale of 0-10 with 0=no pain at all and 10=worst possible pain
Time Frame	110 min

Outcome Measure Data

Analysis Population Description

Patients remaining on procedure table

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	4	2	1
Median (Inter-Quartile Range) [units on a scale]	8.5	3	10

28. Primary Outcome

Title	Time Trends of Pain Experience
Description	Ordinal regression analysis looks at data as a series of possible splits of patient responses and assesses the odds of experiencing a value at or above as compared to the split; e.g. the probability of experiencing self-reported pain scores of 0 vs 1-10; 0-2 vs 3-10 ; 0-4 vs 5-10 etc with pain scores reported between 0=no pain, and 10=worst possible pain. The summary analysis with logit slopes gives in the time trend estimate the cumulative probabilities of the response categories over the variable N=procedure time (min). Positive slopes indicate increasing scores above the split point over time, negative slopes indicate decreasing scores, and flat lines no significant change. In the proportional odds model, an encompassing slope - a probability function of linear trend - is generated that not only applies to the logit forms of the individual splits but to the logic forms of graphs that portray all other splits. The resultant slopes then facilitate comparison among groups.
Time Frame	0-110 min

Outcome Measure Data

Analysis Population Description

Intent to Treat; patients undergoing breast biopsy

Arm/Group Title	Standard of Care	Empathic Attention	Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.	The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)	In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
Measure Participants	76	82	78
Number [logit slopes]	0.53	0.37	0.34

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard of Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Ordinal regression
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Empathic Attention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Ordinal regression
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Self-Hypnotic Relaxation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Ordinal regression
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Empathic Attention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.024
	Comments
	Method	Proportional odds model
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Standard of Care, Self-Hypnotic Relaxation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	Proportional odds model
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Empathic Attention, Self-Hypnotic Relaxation
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	Proportional odds model
	Comments

Adverse Events

Time Frame	Patients were followed for up to one week after their biopsy
Adverse Event Reporting Description	Adverse event reporting was done using the Reporting Standard of the Society of Interventional Radiology
Arm/Group Title	Standard of Care		Empathic Attention		Self-Hypnotic Relaxation
Arm/Group Description	As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.		The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)		In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
All Cause Mortality
	Standard of Care		Empathic Attention		Self-Hypnotic Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard of Care		Empathic Attention		Self-Hypnotic Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/82 (0%)		0/78 (0%)
Other (Not Including Serious) Adverse Events
	Standard of Care		Empathic Attention		Self-Hypnotic Relaxation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/76 (9.2%)		11/82 (13.4%)		3/78 (3.8%)
Surgical and medical procedures
Hematoma	5/76 (6.6%)	5	9/82 (11%)	9	3/78 (3.8%)	3
Vasovagal episode	1/76 (1.3%)	1	2/82 (2.4%)	2	0/78 (0%)	0
Vomiting	1/76 (1.3%)	1	0/82 (0%)	0	0/78 (0%)	0

Limitations/Caveats

For the assessment of the Secondary Outcome parameter we were able to recruit only 19 women whom we could contact early enough on the day of their breast cancer surgery to fill out the IES. This limits the power of the statistical analysis.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.