HPMADOP: Hypnosis in Pain Management, Anxiety and Depression in Oncological Patients

• Sponsor: Gil Montenegro (Other)
• Overall Status: Completed
• CT.gov ID: NCT02105740
• Collaborator: University of Brasilia (Other)
• Enrollment: 24
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

The aim of this trial is to compare and evaluate the effects of hypnosis in cancer patients, to reduce the level of pain, anxiety and depression. The comparison was made through the scores on the Visual Analogue Scale (VAS) and the Hospital Anxiety and Depression Scale (HADS).

Condition or Disease	Intervention/Treatment	Phase
Pain; Depression Anxiety Disorder	Behavioral: Hypnosis; Behavioral: Control	N/A

Detailed Description

Volunteers cancer patients of both gender, aged between 40 and 70 years, susceptible to hypnosis, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS), will be randomized into two groups of 12 participants each. They might or might not present metastasis, whether or not performed cancer surgery, regardless of the location of the primary tumor, with or without concomitant surgical indication. It will be used the Visual Analogue Scale (VAS) and Hospital Anxiety and Depression Scale (HADS) at 3 different times: at baseline, after 7 days and after 2 weeks of the first assessment. It will be done, in the hypnosis group, an hypnosis intervention. It consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression. Then, it will be evaluated the intensity of the pain as well as depression and anxiety in both groups. Finally, the results of both groups will be compared.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Hypnosis as a Complementary Practice in Pain Management, Anxiety and Depression in Oncological Patients
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypnosis Use of hypnosis in the reduction of the levels of pain, depression and anxiety.	Behavioral: Hypnosis; The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same.
Active Comparator: Control Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.	Behavioral: Control; The control and experimental groups respond in 3 different moments to Visual Analogue Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting will be made before the hypnosis. In the second meeting, within an interval of 7 days, the scales will be applied in all patients. Before applying the scales, the hypnosis group will be submitted to the session. The third meeting will occur two weeks later, where the scales will be only applied to compare the groups.

Outcome Measures

Primary Outcome Measures

1. Change of Pain Score in the Visual Analogue Scale [The study was done with each patient in the first three consecutive weeks after randomization]

   Comparison was made through the scores in the Visual Analogue Scale (VAS) to measure the effect of hypnosis in pain among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale ranged from 0 to 10 points, without subscales. The better outcome occurs when the mean of the second or the third week decrease 3 points comparing with the first week, or when the mean of the third week decrease 3 points comparing with the second week.

Secondary Outcome Measures

1. Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS) [The study was done with each patient in the first three consecutive weeks after randomization]

   Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients of Both sexes

• Aged 40-70 years susceptible to hypnosis

• Who have cancer of the digestive tract and pain resulting from this cancer treatment These may or may not have metastasis, have done or not cancer surgery, regardless of the location of the primary tumor or its presence,with or without concomitant surgical indication.This will include patients who have pain scores ≥ 3 in the Visual Analogue Scale (VAS).

Exclusion Criteria:

• Patient not suggestible to hypnosis

• Psychotropic drug users,

• Patients with severe psychiatric disorder, except depression and anxiety

,- Patient terminally ill cancer

• Patients with tumor or cancer metastasis in the central nervous system, _ Deaf and people with mental disabilities and cognitive.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNB- Universidade de Brasilia	Brasilia	Distrito Federal	Brazil	70910900

Sponsors and Collaborators

• Gil Montenegro
• University of Brasilia

Investigators

• Principal Investigator: GIL MONTENEGRO, DOUTORANDO,

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bardia A, Barton DL, Prokop LJ, Bauer BA, Moynihan TJ. Efficacy of complementary and alternative medicine therapies in relieving cancer pain: a systematic review. J Clin Oncol. 2006 Dec 1;24(34):5457-64. Review.
• Lalla RV, Sonis ST, Peterson DE. Management of oral mucositis in patients who have cancer. Dent Clin North Am. 2008 Jan;52(1):61-77, viii. Review.
• Landier W, Tse AM. Use of complementary and alternative medical interventions for the management of procedure-related pain, anxiety, and distress in pediatric oncology: an integrative review. J Pediatr Nurs. 2010 Dec;25(6):566-79. doi: 10.1016/j.pedn.2010.01.009. Epub 2010 Mar 12. Review.
• Montgomery GH, Bovbjerg DH, Schnur JB, David D, Goldfarb A, Weltz CR, Schechter C, Graff-Zivin J, Tatrow K, Price DD, Silverstein JH. A randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients. J Natl Cancer Inst. 2007 Sep 5;99(17):1304-12. Epub 2007 Aug 28.
• Porter LS, Keefe FJ. Psychosocial issues in cancer pain. Curr Pain Headache Rep. 2011 Aug;15(4):263-70. doi: 10.1007/s11916-011-0190-6. Review.
• Spiegel D, Bloom JR. Group therapy and hypnosis reduce metastatic breast carcinoma pain. Psychosom Med. 1983 Aug;45(4):333-9.
• Trijsburg RW, van Knippenberg FC, Rijpma SE. Effects of psychological treatment on cancer patients: a critical review. Psychosom Med. 1992 Jul-Aug;54(4):489-517. Review.

• Responsible Party: Gil Montenegro, PhD student in medical science, University of Brasilia
• ClinicalTrials.gov Identifier: NCT02105740
• Other Study ID Numbers: UNB19739513900000030
• First Posted: Apr 7, 2014
• Last Update Posted: Mar 30, 2017
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Gil Montenegro, PhD student in medical science, University of Brasilia: BEHAVIORAL; HYPNOSIS; ANXIETY; DEPRESSION
• Additional relevant MeSH terms: Depression; Depressive Disorder; Anxiety Disorders

Study Results

Participant Flow

Recruitment Details	The recruitment process was conducted from March to December 2015. Thirty nine patients were invited. They had cancer of digestive tract from both genders, of 40-70 years, with pain scores ≥ 3 by (EVA). Were excluded: patients that used psychotropic drugs, with psychiatric disorders, terminally ill cancer, hearing impaired and mentally disabled.
Pre-assignment Detail	Were excluded: 3 patients weren't suggestible, 3 patients who had terminal cancer, 2 patients who reported low scores, and 7 patients for other reasons such as religious issues or not accepting the technique. One patient dropped out the treatment because he had limited mobility to return to the hospital.

Arm/Group Title	Hypnosis	Control
Arm/Group Description	Use of hypnosis in the reduction of the levels of pain, depression and anxiety. Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression.	Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain, anxiety and depression with the application of the scales. Control x Hypnosis Group: The control and hypnosis groups respond in 3 different distinct moments, with the Visual Analogue Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group, after the follow-up visit. The third evaluation will occur two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety.
Period Title: Overall Study
STARTED	12	12
Second	12	11
COMPLETED	12	11
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Hypnosis	Control	Total
Arm/Group Description	Use of hypnosis to reduct the levels of pain, depression and anxiety. Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same.	Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales. Control : The control and experimental groups respond in 3 different moments to Visual Analog Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting was made before the hypnosis. In the second meeting, within an interval of 7 days, the scales were applied in all patients. Before applying the scales, the hypnosis group was submitted to the session. The third meeting occurred two weeks later, where the scales were only applied to compare the groups.	Total of all reporting groups
Overall Participants	12	12	24
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.4 (6.6)	55.8 (7.5)	55.5 (6.5)
Sex: Female, Male (Count of Participants)
Female	6 50%	7 58.3%	13 54.2%
Male	6 50%	5 41.7%	11 45.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	12 100%	12 100%	24 100%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Brazil	12 100%	12 100%	24 100%
Pain (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	7.3 (2.4)	5.6 (2.0)	6.4 (2.3)
Anxiety (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	11.5 (4.6)	11.3 (4.4)	11.4 (4.4)
Depression (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	9.8 (5.3)	9.0 (3.8)	9.4 (4.5)

Outcome Measures

1. Primary Outcome

Title	Change of Pain Score in the Visual Analogue Scale
Description	Comparison was made through the scores in the Visual Analogue Scale (VAS) to measure the effect of hypnosis in pain among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale ranged from 0 to 10 points, without subscales. The better outcome occurs when the mean of the second or the third week decrease 3 points comparing with the first week, or when the mean of the third week decrease 3 points comparing with the second week.
Time Frame	The study was done with each patient in the first three consecutive weeks after randomization

Outcome Measure Data

Analysis Population Description

24 cancer patients were allocated. They were aged between 40-70 years, of both genders, with pain scores ≥ 3 measured by Visual Analogue Scale (VAS). One patient of the control group left the research.

Arm/Group Title	Hypnosis	Control
Arm/Group Description	Use of hypnosis to change the levels of pain. Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms.	Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain with the application of the Visual Analogue Scale (VAS). Control x Hypnosis Group: The control and the hypnosis groups respond in 3 different distinct moments, using the Visual Analogue Scale (VAS) to evaluate the pain. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was made two weeks later, in order to provide a follow-up to assess the efficacy of the technique.
Measure Participants	12	11
First Week	7.33 (2.38)	5.58 (2.06)
Second Week	3.67 (2.77)	5.67 (3.36)
Third Week	2.08 (2.61)	4.75 (3.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hypnosis, Control
	Comments	The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) for both arms with a statistical power of 95%, significance level of 5%. Statistical analysis first compared the difference of means between hypnosis and control groups during three weeks.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.67
	Confidence Interval	(2-Sided) 95%; 0.224 to 5.110
	Parameter Dispersion	Type: Standard Deviation; Value: 1.178
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Hypnosis
	Comments	The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the second week in the hypnosis group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.66
	Confidence Interval	(2-Sided) 95%; 1.253 to 6.080
	Parameter Dispersion	Type: Standard Deviation; Value: 0.856
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Hypnosis
	Comments	The clinical significance was considered with a difference of 3 points on the Visual Analogue Scale (VAS) with a statistical power of 95%, significance level of 5%. Statistical analysis compared the difference in pain average between the first and the third week in the hypnosis group.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.000
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	5.25
	Confidence Interval	(2-Sided) 95%; 2.918 to 7.582
	Parameter Dispersion	Type: Standard Deviation; Value: 0.827
	Estimation Comments

2. Secondary Outcome

Title	Change of Anxiety and Depression in the Hospital Anxiety and Depression Scale (HADS)
Description	Comparison was made through the scores in the Hospital Anxiety and Depression Scale (HADS) to measure the effect of hypnosis in anxiety and depression among the 12 patients of the hypnosis group comparing to the 11 patients of the control group. The scale has 14 items, seven of which are directed to the evaluation of anxiety (HADS-A) and seven to depression (HADS-D). Each item can be scored from zero to three, establishing a score range of 0 to 21 points for each subscale. The better outcome occurs when the mean is lower or equal to 9 for each subscale. The subscales are independent for each result of depression and anxiety.
Time Frame	The study was done with each patient in the first three consecutive weeks after randomization

Outcome Measure Data

Analysis Population Description

Were allocated 24 cancer patients, aged between 40-70 years, of both genders, with depression and anxiety score ≥ 9 in Hospital Anxiety and Depression Scale (HADS). One patient of the control group left the research.

Arm/Group Title	Hypnosis	Control
Arm/Group Description	Use of hypnosis in the reduction of the levels depression and anxiety. Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same.	Comparison of the effects of hypnosis between the control group and the experimental group regarding anxiety and depression with the application of the Hospital Anxiety and Depression Scale (HADS). Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Hospital Anxiety and Depression Scale (HADS) to evaluate depression and anxiety. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group was compared in relation to the intensity of the depression and anxiety
Measure Participants	12	11
Anxiety First Week	11.50 (4.60)	11.33 (4.41)
Anxiety Second Week	8.17 (3.76)	11.50 (2.43)
Anxiety Third Week	7.50 (3.39)	8.89 (5.96)
Depression First Week	9.75 (5.32)	9.00 (3.76)
Depression Second Week	7.00 (5.46)	8.75 (4.75)
Depression Third Week	6.25 (3.98)	7.75 (5.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Hypnosis, Control
	Comments	Statistical analysis evaluated if the difference of averages of anxiety at the hypnosis and control groups in the third week.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.39
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Hypnosis, Control
	Comments	Statistical analysis evaluated if the difference of averages of depression at the hypnosis and control groups in the third week.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.5
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Hypnosis		Control
Arm/Group Description	Use of hypnosis in the reduction of the levels of pain, depression and anxiety. Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same.		Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales. Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Visual Analog Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation will be two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety
All Cause Mortality
	Hypnosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Hypnosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Hypnosis		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)

Limitations/Caveats

The hypnosis group were not blinded to the intervention. A short follow-up was given to each patient. The use of drugs was imbalanced among participants.

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.