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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04687085
Enrollment
100
Registered
2020-12-29
Start date
2020-12-21
Completion date
2021-11-30
Last updated
2022-03-04

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

Conditions

Anxiety, Pain

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.

Interventions

OTHER10 minute mindful meditation recording

10 minute mindful meditation recording

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Anxiety level after epidural catheter placementMeasure 1 time, 10 minutes after epidural catheter placementLevel of anxiety on a numerical rating scale
Pain level after epidural catheter placementMeasure 1 time, 10 minutes after epidural catheter placementLevel of pain on a numerical rating scale

Secondary

MeasureTime frameDescription
Provider satisfaction level after epidural catheter placementMeasure 1 time, 10 minutes after epidural catheter placementAnesthesia provider placing the epidural catheter satisfaction with placement conditions on a numerical rating scale

Countries

United States

Outcome results

None listed

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