[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575113":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":42,"studyPopulation":42,"armGroups":47,"interventions":58,"overallOfficials":42,"centralContacts":64,"locations":74,"responsibleParty":92,"collaborators":96,"id":99,"slug":42,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":42,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":42,"enrollmentInfo":107,"targetDuration":42,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":117,"overallStatus":77,"whyStopped":42,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Catharina Ziekenhuis Eindhoven","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Post-intervention external cephalic version success rate","The success rate of the external cephalic versions (successful\u002Fnot successful) will be compared between the intervention and control group.","1 hour after enrollment (i.e., in hospital, after intervention and external cephalic version)",[14,17],{"measure":15,"description":16,"timeFrame":12},"Post-intervention pain perception","The pain experienced during the external cephalic version will be assessed with a visual analogue scale (VAS). The mean\u002Fmedian 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.",{"measure":18,"description":19,"timeFrame":12},"Post-intervention comfort","Comfort during the external cephalic version will be assessed with a visual analogue scale (VAS). The mean\u002Fmedian 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.",[21,25,28,31,34],{"measure":22,"description":23,"timeFrame":24},"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.","At baseline (i.e., in hospital, prior to intervention and external cephalic version)",{"measure":26,"description":27,"timeFrame":24},"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.",{"measure":29,"description":30,"timeFrame":24},"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.",{"measure":32,"description":33,"timeFrame":12},"Post-intervention general questions","Three general questions about the information that women received during the external cephalic version, and the familiarity with mindfulness\u002Fyoga.",{"measure":35,"description":36,"timeFrame":12},"Post-intervention evaluation of the intervention","Four questions about how women perceived the intervention (intervention group only)",{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":42,"timePerspective":42,"maskingInfo":43},"RANDOMIZED","PARALLEL","Randomization stratified for parity.","TREATMENT",null,{"masking":44,"maskingDescription":42,"whoMasked":45},"SINGLE",[46],"CARE_PROVIDER",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Intervention group","EXPERIMENTAL","Short mindfulness-based intervention (5 minutes) prior to the external cephalic version",[53],"Behavioral: Short mindfulness-based intervention",{"label":55,"type":56,"description":57,"interventionNames":42},"Control group","NO_INTERVENTION","Care as usual",[59],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":42},"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.",[49],[65,70],{"name":66,"role":67,"phone":68,"phoneExt":42,"email":69},"Simone MI Kuppens, MD, PhD","CONTACT","0031402399300","simone.kuppens@catharinaziekenhuis.nl",{"name":71,"role":67,"phone":72,"phoneExt":42,"email":73},"Lianne P Hulsbosch, PhD","0134664213","l.p.hulsbosch@tilburguniversity.edu",[75],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Catharina Hospital","RECRUITING","Eindhoven","North Brabant","5623 EJ","Netherlands","NL",{"type":84,"coordinates":85},"Point",[86,87],5.47778,51.44083,{"lat":87,"lon":86},[90,91],{"name":66,"role":67,"phone":68,"phoneExt":42,"email":69},{"name":71,"role":67,"phone":72,"phoneExt":42,"email":73},{"type":93,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"PRINCIPAL_INVESTIGATOR","Simone Kuppens","Principal Investigator",[97],{"name":98,"class":6},"Tilburg University","100575113",false,"NCT06768060","Mindfulness-based Intervention Prior to External Cephalic Version","Preparing Mothers for External Cephalic Version: a Mindfulness-based Intervention for Pregnant Women With a Baby in Breech Presentation","Inclusion Criteria:\n\n* Pregnant women (18+y).\n* With a breech presenting fetus undergoing external cephalic version.\n* Dutch\u002FEnglish-speaking or understanding Dutch\u002FEnglish.","FEMALE","18 Years",{"count":108,"type":109},148,"ESTIMATED","INTERVENTIONAL",[112],"NA","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.",[115,116],"Breech Presentation in Pregnancy","External Cephalic Version",[118,119,120,121],"Breech presentation","Pregnancy","External cephalic version","Mindfulness intervention","2026-03-17",{"date":124,"type":125},"2026-03-18","ACTUAL",{"date":127,"type":125},"2025-02-27",{"date":129,"type":109},"2028-01-31",{"name":5,"class":6},1]