Mindfulness-based Intervention Prior to External Cephalic Version

NCT06768060 | Recruiting

• 1 other identifier: W24.245
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomized controlled trial examining the effectiveness of a short mindfulness-based intervention on the success rate of external cephalic version in pregnant women with breech presentation. It is hypothesized that this intervention will increase the ECV success rate and decrease the pain experienced after the ECV.

Conditions

Breech Presentation in Pregnancy; External Cephalic Version

Keywords

Breech presentation; Pregnancy; External cephalic version; Mindfulness intervention

Outcome Measures

Primary Outcomes (1)

• Post-intervention external cephalic version success rate

  The success rate of the external cephalic versions (successful/not successful) will be compared between the intervention and control group.

  1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)

Secondary Outcomes (2)

• Post-intervention pain perception

  1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)

• Post-intervention comfort

  1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)

Other Outcomes (5)

• Baseline mindfulness skills

  At baseline (i.e., in hospital, prior to intervention and external cephalic version)

• Baseline depressive symptoms

  At baseline (i.e., in hospital, prior to intervention and external cephalic version)

• Baseline fear of external cephalic version

  At baseline (i.e., in hospital, prior to intervention and external cephalic version)

Study Arms (2)

Intervention group

EXPERIMENTAL

Short mindfulness-based intervention (5 minutes) prior to the external cephalic version

Behavioral: Short mindfulness-based intervention

Control group

NO INTERVENTION

Care as usual

Interventions

Short mindfulness-based intervention BEHAVIORAL

The intervention includes a short mindfulness-based intervention with a duration of 5 minutes. It involves a sitting mediation focused on breath adapted from the existing protocols of the Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT). The intervention is audio-guided and will be delivered via headphones.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women (18+y).
• With a breech presenting fetus undergoing external cephalic version.
• Dutch/English-speaking or understanding Dutch/English.

Sponsors & Collaborators

• Catharina Ziekenhuis Eindhoven: lead
• Tilburg University: collaborator

Study Sites (1)

Catharina Hospital

Eindhoven, North Brabant, 5623 EJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Breech Presentation

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Simone MI Kuppens, MD, PhD

CONTACT

0031402399300; simone.kuppens@catharinaziekenhuis.nl

Lianne P Hulsbosch, PhD

CONTACT

0134664213; l.p.hulsbosch@tilburguniversity.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomization stratified for parity.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 10, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

NL (1)