Mindfulness-based Intervention Prior to External Cephalic Version
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Short mindfulness-based intervention.
- Who it may be relevant to
- Registry conditions: Breech Presentation in Pregnancy, External Cephalic Version. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women With a Baby in Breech Presentation
Overview
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
- Behavioral 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.
Primary outcome measures
- Post-intervention external cephalic version success rate [Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)]
Secondary outcome measures (2)
- Post-intervention pain perception [Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)]
- Post-intervention comfort [Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)]
Eligibility criteria
Inclusion criteria
- Pregnant women (18+y).
- With a breech presenting fetus undergoing external cephalic version.
- Dutch/English-speaking or understanding Dutch/English.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Catharina Hospital — Eindhoven
Identifiers
NCT: NCT06768060 · W24.245