[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658661":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":28,"studyPopulation":20,"armGroups":29,"interventions":40,"overallOfficials":45,"centralContacts":50,"locations":59,"responsibleParty":73,"collaborators":20,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":20,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":20,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":103,"whyStopped":20,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Sakarya University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Perception of Traumatic Childbirth Scale score","The 13-item Perception of Traumatic Childbirth Scale measures anticipated traumatic childbirth perception. Total scores range from 0 to 130; higher scores indicate a stronger perception of traumatic childbirth. Change from baseline will be compared between groups.","Baseline, immediately after the 4-week intervention, and 1 and 3 months after the intervention",[14,17],{"measure":15,"description":16,"timeFrame":12},"Change in Behavioral Emotion Regulation Questionnaire subscale scores","The 20-item Behavioral Emotion Regulation Questionnaire assesses five behavioral strategies: seeking distraction, withdrawal, actively approaching, seeking social support, and ignoring. Items are rated from 1 to 5. Higher subscale scores indicate more frequent use of the corresponding strategy. Changes in subscale scores will be compared between groups.",{"measure":18,"description":19,"timeFrame":12},"Change in Brief Resilience Scale score","The 6-item Brief Resilience Scale assesses psychological resilience. Items are rated from 1 to 5, with items 2, 4, and 6 reverse-coded. Higher scores indicate greater psychological resilience. Change from baseline will be compared between groups.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":24,"primaryPurpose":25,"observationalModel":20,"timePerspective":20,"maskingInfo":26},"RANDOMIZED","PARALLEL","experimental and control group","PREVENTION",{"masking":27,"maskingDescription":20,"whoMasked":20},"NONE","This is a two-arm, parallel-group randomized controlled study with assessments before the intervention, immediately after the intervention, and at one-month and three-month follow-up. The study will be conducted with pregnant women attending antenatal education services in Bartın, Türkiye.\n\nEligible participants will be randomly allocated to the intervention or control group using a randomization sequence prepared by a person who is not involved in the study. Because of the nature of the intervention, participants and intervention providers cannot be blinded.\n\nThe mandala-based program consists of eight sessions delivered twice weekly over four weeks. Each session lasts approximately 45 minutes: a five-minute introduction and breathing exercise, 35 minutes of themed mandala coloring, and five minutes for participants to reflect on their experience. Session themes address present-moment awareness, adjustment to bodily changes, personal strengths, hope, motherhood, preparation for childbirth, and integration of the program experience. The control group will not receive the study intervention.\n\nThe study will assess perceived traumatic childbirth using the Perception of Traumatic Childbirth Scale, behavioral emotion regulation using the Behavioral Emotion Regulation Questionnaire, and psychological resilience using the Brief Resilience Scale. These measures will be administered to both groups at baseline, immediately after the four-week intervention period, and at one and three months after the intervention.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"Experimental group","EXPERIMENTAL","Eight 45-minute mandala-based sessions over four weeks, delivered twice weekly.",[35],"Behavioral: Mandala-Based",{"label":37,"type":38,"description":39,"interventionNames":20},"control","NO_INTERVENTION","Participants will receive no study intervention. Outcome assessments will be performed at the same time points as in the intervention group.",[41],{"type":42,"name":43,"description":33,"armGroupLabels":44,"otherNames":20},"BEHAVIORAL","Mandala-Based",[31],[46],{"name":47,"affiliation":48,"role":49},"Güleser ADA, PhD","Bartın Unıversity","PRINCIPAL_INVESTIGATOR",[51,55],{"name":47,"role":52,"phone":53,"phoneExt":20,"email":54},"CONTACT","538-450-85-47","gada@bartin.edu.tr",{"name":56,"role":52,"phone":57,"phoneExt":20,"email":58},"Ebru CİRBAN EKREM, PhD","534-392-16-20","ecirban@bartin.edu.tr",[60],{"facility":61,"status":20,"city":62,"state":62,"zip":63,"country":64,"countryCode":20,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Bartın University","Bartın","74100","Turkey (Türkiye)",{"type":66,"coordinates":67},"Point",[68,69],32.3375,41.63583,{"lat":69,"lon":68},[72],{"name":47,"role":52,"phone":20,"phoneExt":20,"email":54},{"type":49,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":48,"oldNameTitle":20,"oldOrganization":20},"GÜLESER ADA","Assistant Professor","100658661","mandala-based-intervention-in-pregnancy-a-randomized-controlled-trial-100658661",false,"NCT07855289","Mandala-Based Intervention in Pregnancy: A Randomized Controlled Trial","The Effect of a Mandala-Based Intervention on Traumatic Childbirth Perception, Behavioral Emotion Regulation, and Psychological Resilience in Pregnant Women: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Being between the ages of 18 and 49,\n* Being in the 1st, 2nd, or 3rd trimester,\n* Volunteering to participate in the study,\n* Completing the forms in full,\n\nExclusion Criteria:\n\n* Having a diagnosis of a high-risk pregnancy,\n* Not wishing to continue with the study,\n* Experiencing communication difficulties (not knowing Turkish, or having hearing, speech, or comprehension impairments),",true,"FEMALE","18 Years","49 Years",{"count":88,"type":89},58,"ESTIMATED","INTERVENTIONAL",[92],"NA","This study will examine whether a mandala-based coloring program affects pregnant women's perceptions of traumatic childbirth, behavioral emotion regulation, and psychological resilience. Pregnant women aged 18 to 49 years will be randomly assigned to a mandala intervention group or a control group.\n\nParticipants in the intervention group will attend eight 45-minute sessions over four weeks (two sessions per week). Sessions will include brief preparation and breathing exercises, mandala coloring, and a short discussion. The control group will receive no study intervention. Participants in both groups will complete questionnaires before the intervention, immediately afterward, and at one-month and three-month follow-up assessments. Researchers will compare changes in the groups' questionnaire scores.",[95,96,97],"Perception of Traumatic Childbirth","Psychological Resilience","Behavioral Emotion Regulation",[99,100,101,102],"Pregnancy","Mandala Coloring","Antenatal Care","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-09-28",{"date":106,"type":107},"2026-10-02","ACTUAL",{"date":109,"type":89},"2026-10-30",{"date":111,"type":89},"2027-09-30",{"name":5,"class":6},1]