An interventional study of Short mindfulness-based intervention in Breech Presentation in Pregnancy and External Cephalic Version, sponsored by Catharina Ziekenhuis Eindhoven. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Catharina Ziekenhuis Eindhoven · Not applicable, Interventional, and Treatment
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.
41 studies on the registry are indexed under Breech Presentation; 10 are open to participants now.
This study's planned enrollment of 148 is above the median of 119 across 31 interventional studies indexed under Breech Presentation.
Browse Breech Presentation studies →Catharina Ziekenhuis Eindhoven is the lead sponsor of 85 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Short mindfulness-based intervention (5 minutes) prior to the external cephalic version
Behavioral: Short mindfulness-based intervention
Care as usual
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.
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.
Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Post-intervention pain perception
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.
Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Post-intervention comfort
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.
Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Baseline mindfulness skills
Baseline mindfulness skills are assessed with the 15-item Three Facet Mindfulness Questionnaire Short Form (TFMQ-SF), consisting of the facets acting with awareness, non-judging and non-reacting. The total score ranges from 0 to 60, with higher scores indicating better mindfulness skills. The validity of the measure is established and indices of internal reliability were found to be adequate.
Time frame: At baseline (i.e., in hospital, prior to intervention and external cephalic version)
Baseline depressive symptoms
Assessed with the 10-item Edinburgh Postnatal Depression Scale (EPDS). The EPDS is the most widely used self-rating scale to assess depressive symptoms in the perinatal period. The EPDS total score ranges from 0 to 30, with higher scores indicating more depressive symptoms. The questionnaire has been validated in Dutch postpartum women.
Time frame: At baseline (i.e., in hospital, prior to intervention and external cephalic version)
Baseline fear of external cephalic version
Assessed with a visual analogue skill (VAS), by which participants indicate how anxious they feel about the upcoming external cephalic version. The scores range from 0 to 10, with higher scores indicating more anxiety about the upcoming external cephalic version.
Time frame: At baseline (i.e., in hospital, prior to intervention and external cephalic version)
Post-intervention general questions
Three general questions about the information that women received during the external cephalic version, and the familiarity with mindfulness/yoga.
Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
Post-intervention evaluation of the intervention
Four questions about how women perceived the intervention (intervention group only)
Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)
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Catharina Ziekenhuis Eindhoven