Mindful Meditation for Epidural Catheter Placement

NCT04687085 | Completed

• 1 other identifier: 2019P003456
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Provider satisfaction level after epidural catheter placement

  Measure 1 time, 10 minutes after epidural catheter placement

Study Arms (2)

Neutral Content

PLACEBO COMPARATOR

Participants will listen to a 10 minute neutral content recording just prior to epidural catheter placement.

Other: 10 minute mindful meditation recording

Mindful Meditation

EXPERIMENTAL

Participants will listen to a 10 minute mindful meditation recording just prior to epidural catheter placement.

Other: 10 minute mindful meditation recording

Interventions

10 minute mindful meditation recording OTHER

10 minute mindful meditation recording

Mindful Meditation; Neutral Content

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Do not speak English or admitted for cesarean delivery will be excluded from the study

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Lumbreras-Marquez MI, Lazaridou A, Villela-Franyutti D, Fields KG, Farber MK, Nelson ER, Schreiber KL, Arce DY. Mindful meditation for epidural catheter placement during labor: a single-center randomized controlled trial. Pain Med. 2026 Jan 1;27(1):26-32. doi: 10.1093/pm/pnaf075.

  PMID: 40570097 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Anesthesia, Harvard Medical School

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 29, 2020
• Study Start: December 21, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)