Mindfulness-based Intervention Prior to External Cephalic Version

NCT ID: NCT06768060

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breech Presentation in Pregnancy External Cephalic Version

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization stratified for parity.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Short mindfulness-based intervention

Intervention Type 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.

Control group

Care as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Short mindfulness-based intervention

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tilburg University

OTHER

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role lead

Responsible Party

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Simone Kuppens

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Catharina Hospital

Eindhoven, North Brabant, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Simone MI Kuppens, MD, PhD

Role: CONTACT

0031402399300

Lianne P Hulsbosch, PhD

Role: CONTACT

0134664213

Facility Contacts

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Simone MI Kuppens, MD, PhD

Role: primary

0031402399300

Lianne P Hulsbosch, PhD

Role: backup

0134664213

Other Identifiers

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W24.245

Identifier Type: -

Identifier Source: org_study_id

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