Mindfulness-based Intervention Prior to External Cephalic Version
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCatharina Ziekenhuis Eindhoven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women (18+y).
With a breech presenting fetus undergoing external cephalic version.
Dutch/English-speaking or understanding Dutch/English.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Short mindfulness-based intervention
BehavioralThe 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.
Treatment groups
148 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)Other outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Catharina Ziekenhuis Eindhoven
Lead sponsor
Tilburg University
Collaborator
Source ClinicalTrials.gov