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NCT Number: NCT06768060

Mindfulness-based Intervention Prior to External Cephalic Version

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.

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Key information

Conditions

Breech Presentation in Pregnancy Breech Presentation External Cephalic Version Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Short mindfulness-based intervention

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.

Primary outcomes

  1. Post-intervention external cephalic version success rate

    Time frame: 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 outcomes

  1. Post-intervention pain perception

    Time frame: 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.

  2. Post-intervention comfort

    Time frame: 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.

Other outcomes

  1. Baseline mindfulness skills

    Time frame: At baseline (i.e., in hospital, prior to intervention and external cephalic version)

    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.

  2. Baseline depressive symptoms

    Time frame: At baseline (i.e., in hospital, prior to intervention and external cephalic version)

    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.

  3. Baseline fear of external cephalic version

    Time frame: At baseline (i.e., in hospital, prior to intervention and 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.

  4. Post-intervention general questions

    Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)

    Three general questions about the information that women received during the external cephalic version, and the familiarity with mindfulness/yoga.

  5. Post-intervention evaluation of the intervention

    Time frame: 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)

    Four questions about how women perceived the intervention (intervention group only)

Study contacts

Contact information is provided by the study sponsor or research team.

Lianne P Hulsbosch, PhD

CONTACT

[email protected]

0134664213

Simone MI Kuppens, MD, PhD

CONTACT

[email protected]

0031402399300

Sponsors and collaborators

Lead sponsor

Catharina Ziekenhuis Eindhoven

Other

Collaborators

  • Tilburg University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 10, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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