Mindful Meditation for Epidural Catheter Placement

Study Overview
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Brief Summary
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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
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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: Decrease anxiety 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.

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

Conditions
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Anxiety, Pain

Intervention / Treatment
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* Other: 10 minute mindful meditation recording


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Neutral Content<br>Participants will listen to a 10 minute neutral content recording just prior to epidural catheter placement. | Other: 10 minute mindful meditation recording<br>* 10 minute mindful meditation recording<br>|
| Experimental: Mindful Meditation<br>Participants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement. | Other: 10 minute mindful meditation recording<br>* 10 minute mindful meditation recording<br>|

What is the study measuring?
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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 |