Mindful Meditation for Epidural Catheter Placement

Effects of a Brief Mindful Meditation Intervention on Patient Anxiety and Satisfaction for Labor Epidural Catheter Placement: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Other: 10 minute mindful meditation recording

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 21, 2020
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (ACTUAL): December 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2019P003456

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To maintain privacy and confidentiality, patient data will be labeled with an alphanumeric code, the key to the code will be kept in a secure location separate from other data forms and will only be accessible to the investigators.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No