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Completed

NCT Number: NCT04687085

Mindful Meditation for Epidural Catheter Placement

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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:

  • Experience an increase in satisfaction with labor epidural catheter placement.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

10 minute mindful meditation recording

Other

10 minute mindful meditation recording

Primary outcomes

  1. Anxiety level after epidural catheter placement

    Time frame: Measure 1 time, 10 minutes after epidural catheter placement

    Level of anxiety on a numerical rating scale

  2. Pain level after epidural catheter placement

    Time frame: Measure 1 time, 10 minutes after epidural catheter placement

    Level of pain on a numerical rating scale

Secondary outcomes

  1. Provider satisfaction level after epidural catheter placement

    Time frame: Measure 1 time, 10 minutes after epidural catheter placement

    Anesthesia provider placing the epidural catheter satisfaction with placement conditions on a numerical rating scale

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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