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Presence of a Companion During Performance of Neuraxial Labor Analgesia

Presence of a Companion During Performance of Neuraxial Labor Analgesia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02982213
Acronym
Companion
Enrollment
150
Registered
2016-12-05
Start date
2016-12-01
Completion date
2017-04-01
Last updated
2021-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Health Knowledge, Attitudes, Practice, Pain

Keywords

Newest Vital Sign, Anxiety, Health literacy, Neuraxial Analgesia, Epidural catheter placement, Pregnancy, Parturients, Pain Catastrophizing Scale, STAI questionnaire, Companion

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.

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.

Interventions

OTHERCompanion Present

A companion will be present during the epidural catheter placement.

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
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 placementThe 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

MeasureTime frameDescription
Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.24 hours after epiduralRecommend care based on presence or absence of a companion received based on Likert type scale of highly unlikely to highly likely.
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 placementAnalysis 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.
Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.After epidural placementAnalysis of the perceived difficulty for the anesthesia resident physician, through utilization of a scale of 0 (severe discomfort to 10 (extremely comfortable).
What is the Preference of Subjects to Have a Companion Present for Future Procedures.24 hours after epidural placementWhat is the preference of subjects having a companion present using 5 point Likert like scale of highly unlikely to highly likely.

Countries

United States

Participant flow

Participants by arm

ArmCount
No Companion Present
No companion is present during the placement of the epidural catheter.
75
Companion Present
A companion will be present during the placement of the epidural catheter. Companion Present: A companion will be present during the epidural catheter placement.
75
Total150

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid not complete follow up questionnaire51

Baseline characteristics

CharacteristicTotalNo Companion PresentCompanion Present
Age, Continuous32 years
STANDARD_DEVIATION 3.7
32.2 years
STANDARD_DEVIATION 3.8
31.8 years
STANDARD_DEVIATION 3.6
Body Mass Index29.4 kg/m2
STANDARD_DEVIATION 6.1
29.2 kg/m2
STANDARD_DEVIATION 4.7
29.6 kg/m2
STANDARD_DEVIATION 7.3
Cervical Dilation3 centimeters3 centimeters3.5 centimeters
Gestational Age40 Weeks40 Weeks40 Weeks
Greatest concern regarding epidural procedure
Complications
51 Participants23 Participants28 Participants
Greatest concern regarding epidural procedure
Ineffective analgesia
31 Participants17 Participants14 Participants
Greatest concern regarding epidural procedure
Other
15 Participants6 Participants9 Participants
Greatest concern regarding epidural procedure
Pain during procedure
43 Participants23 Participants20 Participants
Greatest concern regarding epidural procedure
Unable to tolerate procedure
8 Participants4 Participants4 Participants
Have you spoken to friends or family about labor epidurals?
Did not respond
15 Participants6 Participants9 Participants
Have you spoken to friends or family about labor epidurals?
Yes-mixed comments
26 Participants13 Participants13 Participants
Have you spoken to friends or family about labor epidurals?
Yes-mostly negative comments
4 Participants1 Participants3 Participants
Have you spoken to friends or family about labor epidurals?
Yes-positive comments
102 Participants53 Participants49 Participants
How long have you known your companion (years)?7 Years7.5 Years7 Years
Labor Epidural Performance: Trainee Level
Clinical Anesthesia 1
12 Participants6 Participants6 Participants
Labor Epidural Performance: Trainee Level
Clinical Anesthesia 2
94 Participants48 Participants46 Participants
Labor Epidural Performance: Trainee Level
Clinical Anesthesia 3
36 Participants16 Participants20 Participants
Labor Epidural Performance: Trainee Level
Fellow
2 Participants0 Participants2 Participants
Labor epidural procedural expectations
Long procedure pain not mentioned
3 Participants3 Participants0 Participants
Labor epidural procedural expectations
None
8 Participants4 Participants4 Participants
Labor epidural procedural expectations
Other than pain or duration
8 Participants4 Participants4 Participants
Labor epidural procedural expectations
Painful procedure
26 Participants13 Participants13 Participants
Labor epidural procedural expectations
Short procedure minimal pain
102 Participants49 Participants53 Participants
Labor Type
Induction
82 Participants44 Participants38 Participants
Labor Type
Spontaneous labor
65 Participants29 Participants36 Participants
Newest vital sign
Good health literacy
127 Participants62 Participants65 Participants
Newest vital sign
Low health literacy
22 Participants13 Participants9 Participants
NRS pain score7 units on a scale7 units on a scale7 units on a scale
Number of Attending Anesthesiologist Takeover of Epidural Placement12 Attending Takeovers8 Attending Takeovers4 Attending Takeovers
Number of Participants Categorized by Number of Epidural Catheter Attempts
1 Attempt
124 Participants59 Participants65 Participants
Number of Participants Categorized by Number of Epidural Catheter Attempts
2 Attempts
10 Participants5 Participants5 Participants
Number of Participants Categorized by Number of Epidural Catheter Attempts
Attempts not recorded
10 Participants6 Participants4 Participants
Preprocedure pain catastrophizing scale
Median (quartile)
14 units on a scale12 units on a scale17 units on a scale
Preprocedure pain catastrophizing scale
Upper (quartile)
21 units on a scale18 units on a scale23 units on a scale
Race/Ethnicity, Customized
African American
9 Participants4 Participants5 Participants
Race/Ethnicity, Customized
Asian
22 Participants11 Participants11 Participants
Race/Ethnicity, Customized
Caucasian
100 Participants52 Participants48 Participants
Race/Ethnicity, Customized
Latino/Hispanic
16 Participants6 Participants10 Participants
Race/Ethnicity, Customized
Question not answered
3 Participants2 Participants1 Participants
Region of Enrollment
United States
147 participants75 participants75 participants
Relationship of primary companion
Aunt
1 Participants0 Participants1 Participants
Relationship of primary companion
Brother
1 Participants1 Participants0 Participants
Relationship of primary companion
Female partner
16 Participants10 Participants6 Participants
Relationship of primary companion
Friend
5 Participants2 Participants3 Participants
Relationship of primary companion
Male partner
127 Participants62 Participants65 Participants
Researched epidurals through social media?
No
67 Participants36 Participants31 Participants
Researched epidurals through social media?
Yes
80 Participants37 Participants43 Participants
Resident Assessment of Ability to Palpate Landmarks75 units on a scale78 units on a scale70 units on a scale
Resident Assessment of Ability to Position Patient (0-100)77 units on a scale77 units on a scale78 units on a scale
Resident Assessment of Difficulty of Epidural Procedure79 Score on a scale80 Score on a scale78 Score on a scale
Resident Comfort Performing Procedure (0-10)8 units on a scale8 units on a scale8 units on a scale
Sex: Female, Male
Female
150 Participants75 Participants75 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
State-Trait (STAI) Anxiety Inventory
State
38 Score on a scale38 Score on a scale38 Score on a scale
State-Trait (STAI) Anxiety Inventory
Trait
30 Score on a scale29 Score on a scale31 Score on a scale
Work in medical field?
No
123 Participants61 Participants62 Participants
Work in medical field?
Yes
24 Participants12 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 750 / 75
other
Total, other adverse events
0 / 750 / 75
serious
Total, serious adverse events
0 / 750 / 75

Outcome results

Primary

Maternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
No Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Dissatisfied3 Participants
No Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Satisfied15 Participants
No Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Neutral11 Participants
No Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Highly Satisfied39 Participants
No Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Highly Dissatisfied2 Participants
Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Highly Satisfied61 Participants
Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Highly Dissatisfied2 Participants
Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Dissatisfied0 Participants
Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Neutral1 Participants
Companion PresentMaternal Satisfaction and the Presence of a Companion During the Placement of Epidural Catheter for Labor Analgesia.Satisfied10 Participants
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary

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.

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

ArmMeasureValue (MEDIAN)
No Companion PresentDoes the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire.-7 score on scale
Companion PresentDoes the Desire of Subject to Have the Companion Present Affect the Anxiety of the Subject Measured Using the STAI (State-Trait Anxiety Inventory) Questionnaire.-11 score on scale
Secondary

Does the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.

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

ArmMeasureValue (MEDIAN)
No Companion PresentDoes the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.8 score on scale
Companion PresentDoes the Presence of a Companion Affect the Perceived Difficulty of the Procedure by the Resident Physician Placing the Labor Epidural Catheter.8 score on scale
Secondary

Recommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.

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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
No Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Highly likely32 Participants
No Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.LIkely10 Participants
No Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Neutral22 Participants
No Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Unlikely3 Participants
No Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Highly unlikely3 Participants
No Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Did not respond3 Participants
Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Highly unlikely2 Participants
Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Highly likely59 Participants
Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Unlikely0 Participants
Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.LIkely11 Participants
Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Did not respond0 Participants
Companion PresentRecommend Care Received Based on Experience of Companion Presence in Room During Epidural Procedure.Neutral2 Participants
p-value: 0.001McNemar
Secondary

What is the Preference of Subjects to Have a Companion Present for Future Procedures.

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
No Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Highly likely17 Participants
No Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Likely14 Participants
No Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Neutral22 Participants
No Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Unlikely7 Participants
No Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Highly unlikely10 Participants
No Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Did not respond3 Participants
Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Highly unlikely10 Participants
Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Highly likely30 Participants
Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Unlikely5 Participants
Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Likely15 Participants
Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Did not respond0 Participants
Companion PresentWhat is the Preference of Subjects to Have a Companion Present for Future Procedures.Neutral14 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026