Mindful Meditation for Epidural Catheter Placement

Not Applicable

Completed

• Conditions: Pain; Anxiety
• Interventions: Other: 10 minute mindful meditation recording

• Registration Number: NCT04687085
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

Given the high prevalence of neuraxial analgesia use during labor and the anxiety associated with these procedures, a method to decrease this anxiety could benefit millions of laboring women each year. Mindfulness practice has been used by many groups to decrease anxiety during pregnancy with optimistic results. However, there has been no major study evaluating the role of mindfulness interventions on anxiety associated with neuraxial placement. The purpose of our study is to address this gap in knowledge.

Detailed Description

The primary objective of this study is to evaluate the effects of a brief mindful meditation intervention on anxiety and satisfaction regarding epidural catheter placement for laboring parturients.The investigators hypothesize that a brief mindful meditation intervention, consisting of a 10 minute auditory instructional practice, implemented before epidural catheter placement will:

1. Decrease anxiety

2. Increase satisfaction

compared to a neutral 10 minute auditory recording control, in participants undergoing labor epidural catheter placement.

The secondary objective of this study is to evaluate whether anesthesia providers experience a difference in satisfaction with labor epidural catheter placement in participants who listen to a brief mindful meditation intervention prior to epidural catheter placement. The investigators hypothesize that anesthesia providers placing labor epidural catheters in patients who listen to a brief mindful meditation intervention prior to labor epidural catheter placement will:

1. Experience an increase in satisfaction with labor epidural catheter placement.

Study Timeline

• Study Start: 2020-12-21
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-29
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Patients are eligible for enrollment if they are greater than 18 years of age, admitted for vaginal delivery, anticipating epidural analgesia, and report a numerical pain scale rating of 3 or less at the time of enrollment.

Exclusion Criteria

• Do not speak English or admitted for cesarean delivery will be excluded from the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neutral Content	10 minute mindful meditation recording	Participants will listen to a 10 minute neutral content recording just prior to epidural catheter placement.
Mindful Meditation	10 minute mindful meditation recording	Participants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement.

Primary Outcome Measures

Name	Time	Method
Anxiety level after epidural catheter placement	Measure 1 time, 10 minutes after epidural catheter placement	Level of anxiety on a numerical rating scale
Pain level after epidural catheter placement	Measure 1 time, 10 minutes after epidural catheter placement	Level of pain on a numerical rating scale

Secondary Outcome Measures

Name	Time	Method
Provider satisfaction level after epidural catheter placement	Measure 1 time, 10 minutes after epidural catheter placement	Anesthesia provider placing the epidural catheter satisfaction with placement conditions on a numerical rating scale

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States