Mindful Meditation for Epidural Catheter Placement

Sponsor
Brigham and Women's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04687085
Collaborator
(none)
100
1
2
11.3
8.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 10 minute mindful meditation recording
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effects of a Brief Mindful Meditation Intervention on Patient Anxiety and Satisfaction for Labor Epidural Catheter Placement: a Randomized Controlled Trial
Actual Study Start Date :
Dec 21, 2020
Actual Primary Completion Date :
Nov 30, 2021
Actual Study Completion Date :
Nov 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Neutral Content

Participants will listen to a 10 minute neutral content recording just prior to epidural catheter placement.

Other: 10 minute mindful meditation recording
10 minute mindful meditation recording

Experimental: Mindful Meditation

Participants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement.

Other: 10 minute mindful meditation recording
10 minute mindful meditation recording

Outcome Measures

Primary Outcome Measures

  1. Anxiety level after epidural catheter placement [Measure 1 time, 10 minutes after epidural catheter placement]

    Level of anxiety on a numerical rating scale

  2. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dominique Arce, Instructor in Anesthesia, Harvard Medical School, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT04687085
Other Study ID Numbers:
  • 2019P003456
First Posted:
Dec 29, 2020
Last Update Posted:
Mar 4, 2022
Last Verified:
Mar 1, 2022
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 4, 2022