Mindfulness-based Intervention Prior to External Cephalic Version

Not Applicable

Not yet recruiting

• Conditions: Breech Presentation in Pregnancy; External Cephalic Version

• Registration Number: NCT06768060
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-17
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-06
• Last Update Submitted: 2025-01-06
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Study Start: 2025-02-01
• Primary Completion: 2027-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 148

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-intervention external cephalic version success rate	1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)	The success rate of the external cephalic versions (successful/not successful) will be compared between the intervention and control group.

Secondary Outcome Measures

Name	Time	Method
Post-intervention pain perception	1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)	The pain experienced during the external cephalic version will be assessed with a visual analogue scale (VAS). The mean/median VAS scores will be compared between the intervention and control group. The scores range between 0 and 10, with a higher score indicating more experienced pain.
Post-intervention comfort	1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)	Comfort during the external cephalic version will be assessed with a visual analogue scale (VAS). The mean/median VAS scores will be compared between the intervention and control group. The scores range between 0 and 10, with a higher score indicating more comfort.

Trial Locations

Locations (1)

Catharina Hospital; 🇳🇱 Eindhoven, North Brabant, Netherlands