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| Name | Class |
|---|---|
| Tilburg University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Short mindfulness-based intervention (5 minutes) prior to the external cephalic version |
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| Control group | No Intervention | Care as usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone MI Kuppens, MD, PhD | Contact | 0031402399300 | simone.kuppens@catharinaziekenhuis.nl | |
| Lianne P Hulsbosch, PhD | Contact | 0134664213 | l.p.hulsbosch@tilburguniversity.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catharina Hospital | Recruiting | Eindhoven | North Brabant | 5623 EJ | Netherlands |
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| ID | Term |
|---|---|
| D001946 | Breech Presentation |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Randomization stratified for parity.
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| 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. | 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version) |
| 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. | 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. | 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. | 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) | 1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version) |