Presence of a Companion During Performance of Neuraxial Labor Analgesia

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02982213
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Actual Duration (Months): 4
• Patients Per Site Per Month: 37.7

Study Details

Study Description

Brief Summary

The purpose of the study is to evaluate if maternal anxiety is improved when a parturient gets her choice with regard to the presence of a companion during epidural catheter placement for labor analgesia. It will be focused on parturients having their first child with the current partner. Additionally, it will investigate the effect of ethnicity, health literacy (as evaluated by the Newest Vital Sign questionnaire), catastrophizing (as evaluated by the Pain Catastrophizing Scale), and the relationship of the support person to the parturient. The investigators hypothesize that there may be specific subgroups in which maternal anxiety is improved when a parturient gets her choice regarding the presence of a companion during labor epidural catheter placement; however, a significant improvement in maternal anxiety, when including all participants, will not be appreciated.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Pain; Health Knowledge, Attitudes, Practice	Other: Companion Present	N/A

Detailed Description

Parturients who have been admitted to the Labor and Delivery ward at Prentice Women's Hospital will be approached by a member of the anesthesia team prior to the placement of a labor epidural catheter. They will be asked if they are considering neuraxial labor analgesia, and if they are they will be screened using the inclusion and exclusion criteria to determine study eligibility. Once they have been evaluated and found to be appropriate for the study, they will be invited to participate.

Participants will be asked to fill out the STAI questionnaire to assess the level of anxiety prior to placement of the labor epidural catheter, and before knowing their group assignment. They will then complete the pre procedure questionnaire. This questionnaire asks about expectations she has for the labor epidural procedure. They will then be given the page of the Newest Vital Signs questionnaire with the Nutrition Facts, and be asked the 6 questions by the recruiter. Then they will be handed the Pain Catastrophizing Scale form with 13 statements, and asked to fill it out as directed in the instructions at the top. They will then be asked who their primary support person is. A form will be handed to that person to confidentially record if he/she would prefer to be present for the procedure. This form will be collected from the companion, and without the parturient aware of the support person's response, she will be asked for her preference with regard to the presence of a companion in the room, which will be recorded on this form as well. Finally, she will be asked which ethnicity she most relates to, also to be recorded on this form.

After all these data have been collected, the parturient will be randomized as to whether her companion will be allowed in the room or will be asked to leave. This will not be communicated to the parturient until the time of the labor epidural catheter placement. When she requests the neuraxial labor analgesia, the provider placing the labor epidural catheter will be made aware of which group she has been randomized to, and will either ask the companion to leave for placement, or provide the support person a non-mobile chair to sit on in front of the parturient for placement of the labor epidural. The companion will be asked to remain in the chair. He/she will be asked to focus on the parturient. It will be emphasized that he/she must remain seated and will not be allowed to observe the procedure being performed. This is to prevent loss of consciousness in the support person, which has been documented in the literature (Devore and Asrani, 1978; Crosby and Halpern, 1989). One violation will result in a warning, and after a second the companion will be escorted out of the room and the participant will be removed from the study.

The provider will place the labor epidural catheter in the regular fashion, as is common practice at Prentice Women's Hospital. After preparation and draping of the skin in the sitting position, infiltration with Lidocaine 1% will be conducted at L3-L4 or L4-L5. A 17g Tuohy needle will be advanced into the epidural space, using a loss of resistance with either saline or air, depending on the provider's preference. After the epidural space has been located, a 27g pencil-tip spinal needle will be placed through the Tuohy, into the intrathecal space, and an intrathecal dose of medication will be administered. The exact dose to be injected will be left up to the discretion of the provider, who will determine the appropriate dose based on the patient's situation at that time. After the intrathecal dose is administered, the spinal needle will be removed and a 19g epidural catheter will be placed through the Tuohy into the epidural space. It will be secured at the skin with a sterile dressing and tape, leaving 5cm of the catheter in the epidural space. The patient will then be placed in a lateral position.

After the completion of the neuraxial procedure, the study participant will then be asked to fill out the STAI questionnaire again. Additionally, she will be asked to record her perception of pain during the placement of the labor epidural catheter, using a VAS (Visual Analogue Scale) from 0-100mm. At that point the parturient's participation in the study will be complete.

The provider placing the labor epidural catheter will be asked to evaluate his/her ability to palpate landmarks for placement, the positioning of the patient, and overall perceived difficulty with the epidural placement, using a VAS from 0-100mm for each, which will be kept confidential.

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Presence of a Companion During Performance of Neuraxial Labor Analgesia
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No companion present No companion is present during the placement of the epidural catheter.
Active Comparator: Companion present A companion will be present during the placement of the epidural catheter.	Other: Companion Present; A companion will be present during the epidural catheter placement.

Outcome Measures

Primary Outcome Measures

1. Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia. [Average 12 hours, up to 24 hours after epidural placement]

   The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied

Secondary Outcome Measures

1. Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire. [24 hours after epidural placement]

   Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from "Almost Never" to "Almost Always"). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group.

2. Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter. [After epidural placement]

   Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).

3. What is the Preference of Subjects to Have a Companion Present for Future Procedures. [24 hours after epidural placement]

   What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.

4. Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure. [24 hours after epidural]

   Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Delivering the first child

• Planning to labor with neuraxial analgesia.

• Additionally, there will need to be sufficient time before delivery to allow the completion of the Pre procedure questionnaire, State-Trait Anxiety Inventory (STAI) questionnaire both before and after the procedure, as well as the Newest Vital Sign questionnaire and the Pain Catastrophizing Scale questionnaire before the procedure.

• They will be included if they are ASA (American Society of Anesthesiologists) 2.

• Able to read and comprehend the English language, as the Newest Vital Sign questionnaire requires them to read and interpret a nutrition label.

Physician Inclusion:

• Anesthesiology Attending Physician, fellow or resident who participants in the placement of the epidural catheter placement

Companion Inclusion:

• Primary companion identified by parturient over the age of 18

Exclusion Criteria:

• Parturients will be excluded if they are receiving neuraxial anesthesia for a cesarean delivery,

• External cephalic version

• Non-labor procedure.

• Subjects will be excluded if they begin to push for delivery before completion of the STAI questionnaire following labor epidural catheter placement.

• They will be excluded if there is no support person present at the time of the neuraxial procedure.

• They will be excluded if they are ASA 3 or greater, or if they have a contraindication to receiving any of the medications routinely used in the placement of a labor epidural catheter (lidocaine, bupivacaine, epinephrine, fentanyl).

• Adults who are unable to consent and minors will be excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prentice Women's Hospital	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University

Investigators

• Principal Investigator: Feyce Peralta, MD, Northwestern University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 11, 2016

More Information

Publications

None provided.

• Responsible Party: Feyce M. Peralta, MD, MS, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT02982213
• Other Study ID Numbers: STU00203896
• First Posted: Dec 5, 2016
• Last Update Posted: Nov 12, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Feyce M. Peralta, MD, MS, Principal Investigator, Northwestern University: Newest Vital Sign; Anxiety; Health literacy; Neuraxial Analgesia; Epidural catheter placement; Pregnancy; Parturients; Pain Catastrophizing Scale; STAI questionnaire; Companion

Study Results

Participant Flow

Arm/Group Title	No Companion Present	Companion Present
Arm/Group Description	No companion is present during the placement of the epidural catheter.	A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Period Title: Overall Study
STARTED	75	75
COMPLETED	70	74
NOT COMPLETED	5	1

Baseline Characteristics

Arm/Group Title	No Companion Present	Companion Present	Total
Arm/Group Description	No companion is present during the placement of the epidural catheter.	A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.	Total of all reporting groups
Overall Participants	75	75	150
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.2 (3.8)	31.8 (3.6)	32 (3.7)
Sex: Female, Male (Count of Participants)
Female	75 100%	75 100%	150 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Caucasian	52 69.3%	48 64%	100 66.7%
African American	4 5.3%	5 6.7%	9 6%
Asian	11 14.7%	11 14.7%	22 14.7%
Latino/Hispanic	6 8%	10 13.3%	16 10.7%
Question not answered	2 2.7%	1 1.3%	3 2%
Region of Enrollment (participants) [Number]
United States	75 100%	75 100%	147 98%
Body Mass Index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	29.2 (4.7)	29.6 (7.3)	29.4 (6.1)
Gestational Age (Weeks) [Mean (Full Range) ]
Mean (Full Range) [Weeks]	40	40	40
NRS pain score (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	7	7	7
Cervical Dilation (centimeters) [Mean (Full Range) ]
Mean (Full Range) [centimeters]	3	3.5	3
Labor Type (Count of Participants)
Induction	44 58.7%	38 50.7%	82 54.7%
Spontaneous labor	29 38.7%	36 48%	65 43.3%
Labor epidural procedural expectations (Count of Participants)
None	4 5.3%	4 5.3%	8 5.3%
Short procedure minimal pain	49 65.3%	53 70.7%	102 68%
Long procedure pain not mentioned	3 4%	0 0%	3 2%
Painful procedure	13 17.3%	13 17.3%	26 17.3%
Other than pain or duration	4 5.3%	4 5.3%	8 5.3%
Greatest concern regarding epidural procedure (Count of Participants)
Pain during procedure	23 30.7%	20 26.7%	43 28.7%
Unable to tolerate procedure	4 5.3%	4 5.3%	8 5.3%
Ineffective analgesia	17 22.7%	14 18.7%	31 20.7%
Complications	23 30.7%	28 37.3%	51 34%
Other	6 8%	9 12%	15 10%
Have you spoken to friends or family about labor epidurals? (Count of Participants)
Yes-positive comments	53 70.7%	49 65.3%	102 68%
Yes-mixed comments	13 17.3%	13 17.3%	26 17.3%
Yes-mostly negative comments	1 1.3%	3 4%	4 2.7%
Did not respond	6 8%	9 12%	15 10%
Researched epidurals through social media? (Count of Participants)
Yes	37 49.3%	43 57.3%	80 53.3%
No	36 48%	31 41.3%	67 44.7%
Relationship of primary companion (Count of Participants)
Male partner	62 82.7%	65 86.7%	127 84.7%
Female partner	10 13.3%	6 8%	16 10.7%
Brother	1 1.3%	0 0%	1 0.7%
Aunt	0 0%	1 1.3%	1 0.7%
Friend	2 2.7%	3 4%	5 3.3%
How long have you known your companion (years)? (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	7.5	7	7
Work in medical field? (Count of Participants)
Yes	12 16%	12 16%	24 16%
No	61 81.3%	62 82.7%	123 82%
Preprocedure pain catastrophizing scale (units on a scale) [Median (Inter-Quartile Range) ]
Median (quartile)	12	17	14
Upper (quartile)	18	23	21
Newest vital sign (Count of Participants)
Good health literacy	62 82.7%	65 86.7%	127 84.7%
Low health literacy	13 17.3%	9 12%	22 14.7%
State-Trait (STAI) Anxiety Inventory (Score on a scale) [Mean (Full Range) ]
State	38	38	38
Trait	29	31	30
Labor Epidural Performance: Trainee Level (Count of Participants)
Clinical Anesthesia 1	6 8%	6 8%	12 8%
Clinical Anesthesia 2	48 64%	46 61.3%	94 62.7%
Clinical Anesthesia 3	16 21.3%	20 26.7%	36 24%
Fellow	0 0%	2 2.7%	2 1.3%
Number of Participants Categorized by Number of Epidural Catheter Attempts (Count of Participants)
1 Attempt	59 78.7%	65 86.7%	124 82.7%
2 Attempts	5 6.7%	5 6.7%	10 6.7%
Attempts not recorded	6 8%	4 5.3%	10 6.7%
Number of Attending Anesthesiologist Takeover of Epidural Placement (Attending Takeovers) [Number]
Number [Attending Takeovers]	8	4	12
Resident Assessment of Difficulty of Epidural Procedure (Score on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Score on a scale]	80	78	79
Resident Assessment of Ability to Position Patient (0-100) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	77	78	77
Resident Assessment of Ability to Palpate Landmarks (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	78	70	75
Resident Comfort Performing Procedure (0-10) (units on a scale) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [units on a scale]	8	8	8

Outcome Measures

1. Primary Outcome

Title	Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.
Description	The maternal satisfaction after epidural catheter placement for labor analgesia and the presence of a companion scored on a 5 point Likert scale of Highly Dissatisfied, Dissatisfied, Neutral, Satisfied and Highly Satisfied
Time Frame	Average 12 hours, up to 24 hours after epidural placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Companion Present	Companion Present
Arm/Group Description	No companion is present during the placement of the epidural catheter.	A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Measure Participants	70	74
Highly Dissatisfied	2 2.7%	2 2.7%
Dissatisfied	3 4%	0 0%
Neutral	11 14.7%	1 1.3%
Satisfied	15 20%	10 13.3%
Highly Satisfied	39 52%	61 81.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Companion Present, Companion Present
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	.025
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Does the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire.
Description	Analysis of maternal anxiety, pre and post placement of the epidural catheter, using the STAI questionnaire.The STAI is a two part 20 question per part anxiety scale survey. Range of scores for each subtest is 20-80, the higher score indicating greater anxiety. The State-Trait Anxiety Inventory (STAI) is used to measure of trait and state anxiety. There are 20 items for assessing trait anxiety and 20 for state anxiety. Both tests are scored on a 4-point scale (from "Almost Never" to "Almost Always"). Score limit for each test is 20 low to 80 high. Low to mild anxiety is a score of 20-37, moderate anxiety is a score of 38-44 and high anxiety is a score of 45-80. The score represents the difference between the pre STAI and the post procedure STAI in each group.
Time Frame	24 hours after epidural placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Companion Present	Companion Present
Arm/Group Description	No companion is present during the placement of the epidural catheter.	A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Measure Participants	70	74
Median (Inter-Quartile Range) [score on scale]	-7	-11

3. Secondary Outcome

Title	Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.
Description	Analysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).
Time Frame	After epidural placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Companion Present	Companion Present
Arm/Group Description	No companion is present during the placement of the epidural catheter.	A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Measure Participants	70	74
Median (Inter-Quartile Range) [score on scale]	8	8

4. Secondary Outcome

Title	What is the Preference of Subjects to Have a Companion Present for Future Procedures.
Description	What is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.
Time Frame	24 hours after epidural placement

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Companion Present	Companion Present
Arm/Group Description	No companion is present during the placement of the epidural catheter.	A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Measure Participants	73	74
Highly likely	17 22.7%	30 40%
Likely	14 18.7%	15 20%
Neutral	22 29.3%	14 18.7%
Unlikely	7 9.3%	5 6.7%
Highly unlikely	10 13.3%	10 13.3%
Did not respond	3 4%	0 0%

5. Secondary Outcome

Title	Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.
Description	Recommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.
Time Frame	24 hours after epidural

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Companion Present	Companion Present
Arm/Group Description	No companion is present during the placement of the epidural catheter.	A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
Measure Participants	73	74
Highly likely	32 42.7%	59 78.7%
LIkely	10 13.3%	11 14.7%
Neutral	22 29.3%	2 2.7%
Unlikely	3 4%	0 0%
Highly unlikely	3 4%	2 2.7%
Did not respond	3 4%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	No Companion Present, Companion Present
	Comments
	Type of Statistical Test	Equivalence
	Comments	Sample size of 5 per group to achieve 80% power to detect a change in the log odds ration of 1.0 at a .05 significance level using a two sided Mann Whitney U test.
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	McNemar
	Comments

Adverse Events

Time Frame	24 hours after delivery of the baby.
Adverse Event Reporting Description	Emotional distress answering some of the questionnaires as reported by the subject to the study team members.
Arm/Group Title	No Companion		Companion Present
Arm/Group Description	No companion in the room during the procedure		Companion present during the procedure
All Cause Mortality
	No Companion		Companion Present
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Serious Adverse Events
	No Companion		Companion Present
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)
Other (Not Including Serious) Adverse Events
	No Companion		Companion Present
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/75 (0%)		0/75 (0%)

Limitations/Caveats

The limitation is our sample was primarily Caucasian with mid to high socioeconomic status. Additionally, most of the companions were married to the study 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.