Mindfulness-based Intervention Prior to External Cephalic Version

Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women With a Baby in Breech Presentation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06768060

Enrollment

148

Registered

2025-01-10

Start date

2025-02-27

Completion date

2028-01-31

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breech Presentation in Pregnancy, External Cephalic Version

Keywords

Breech presentation, Pregnancy, External cephalic version, Mindfulness intervention

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.

Interventions

BEHAVIORALShort 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Intervention model description

Randomization stratified for parity.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Netherlands

Contacts

CONTACTSimone MI Kuppens, MD, PhD

simone.kuppens@catharinaziekenhuis.nl0031402399300

CONTACTLianne P Hulsbosch, PhD

l.p.hulsbosch@tilburguniversity.edu0134664213

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026