Mindful Meditation for Epidural Catheter Placement

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687085
• Other study ID #: 2019P003456
• Status: Completed
• Phase: N/A
• Start date: December 21, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: March 2022
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety level after epidural catheter placement	Level of anxiety on a numerical rating scale	Measure 1 time, 10 minutes after epidural catheter placement
Primary	Pain level after epidural catheter placement	Level of pain on a numerical rating scale	Measure 1 time, 10 minutes after epidural catheter placement
Secondary	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