[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625267":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":25,"studyPopulation":16,"armGroups":26,"interventions":37,"overallOfficials":43,"centralContacts":47,"locations":58,"responsibleParty":78,"collaborators":16,"id":80,"slug":16,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":16,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":16,"enrollmentInfo":88,"targetDuration":16,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":61,"whyStopped":16,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Selcuk University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change in State Anxiety Score","State anxiety will be measured using the State Anxiety Inventory (STAI-State). The primary outcome is the change in anxiety score from baseline at hospital admission to immediately after completion of the mandala coloring session during hospitalization. Higher scores indicate greater anxiety.","At hospital admission (baseline) and immediately after completion of the mandala coloring session (minimum 30 minutes) during hospitalization",{"measure":14,"description":15,"timeFrame":12},"Change in Perceived Stress Score","Perceived stress will be measured using the Perceived Stress Scale (PSS). The secondary outcome is the change in stress score from baseline at hospital admission to immediately after completion of the mandala coloring session during hospitalization. Higher scores indicate greater perceived stress.",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":20,"primaryPurpose":21,"observationalModel":16,"timePerspective":16,"maskingInfo":22},"RANDOMIZED","PARALLEL","Participants are randomized to either a mandala coloring activity group or a control group receiving standard care, and outcomes are assessed and compared between groups during hospitalization.","SUPPORTIVE_CARE",{"masking":23,"maskingDescription":24,"whoMasked":16},"NONE","This is an open-label study due to the nature of the behavioral intervention.","Missed abortion is a distressing pregnancy loss experience that may lead to increased anxiety, stress, and emotional burden in affected women. In addition to psychological distress, acute stress responses may also influence physiological parameters such as heart rate, blood pressure, oxygen saturation, and body temperature. Supportive, non-pharmacological interventions may help reduce emotional and physical discomfort during hospitalization.\n\nMandala coloring is a structured, repetitive art-based activity that may promote relaxation and emotional regulation. It is considered a simple, low-cost, and non-invasive supportive intervention that can be easily implemented in clinical settings.\n\nThis randomized controlled trial is designed to evaluate the effectiveness of mandala coloring activity in women diagnosed with missed abortion. Participants are randomly assigned to either a mandala coloring group receiving the intervention in addition to standard care, or a control group receiving standard care alone. The mandala session lasts a minimum of 30 minutes and is conducted during hospitalization.\n\nStress, state anxiety, and pain levels, along with physiological parameters (heart rate, blood pressure, oxygen saturation, and body temperature), are assessed at baseline (hospital admission) and immediately after completion of the intervention. The study aims to determine whether mandala coloring contributes to improved psychological well-being and physiological stability in women experiencing pregnancy loss.",[27,33],{"label":28,"type":29,"description":30,"interventionNames":31},"Mandala Coloring Group","EXPERIMENTAL","Participants receive mandala coloring activity in addition to standard care during hospitalization.",[32],"Behavioral: Mandala Coloring Activity",{"label":34,"type":35,"description":36,"interventionNames":16},"Control Group","NO_INTERVENTION","Participants receive standard care only during hospitalization.",[38],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":16},"BEHAVIORAL","Mandala Coloring Activity","Participants engage in a structured mandala coloring activity session during hospitalization in addition to standard care. The activity is conducted individually in a quiet environment.",[28],[44],{"name":45,"affiliation":5,"role":46},"Rukiye Arslantaş, MSc","PRINCIPAL_INVESTIGATOR",[48,54],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Rukiye Arslantaş","CONTACT","+905379671005","MSc","rukiyearslantas96@gmail.com",{"name":55,"role":50,"phone":56,"phoneExt":16,"email":57},"Bihter Akın, PhD","+05056703228","bihterakin@yahoo.com",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":16,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Konya City Hospital","RECRUITING","Konya","Selçuklu","42250","Turkey (Türkiye)",{"type":67,"coordinates":68},"Point",[69,70],32.48464,37.87135,{"lat":70,"lon":69},[73,76,77],{"name":74,"role":50,"phone":75,"phoneExt":16,"email":53},"Rukiye Arslantaş, Msc","05379671005",{"name":55,"role":50,"phone":56,"phoneExt":16,"email":57},{"name":45,"role":46,"phone":16,"phoneExt":16,"email":16},{"type":46,"investigatorFullName":49,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Principal Investigator","100625267",false,"NCT07420413","Effects of Mandala Coloring in Missed Abortion","The Effect of Mandala Coloring Activity on Stress, Anxiety, Pain and Physiological Parameters in Women Diagnosed With Missed Abortion: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Women aged 18 years and older\n* Hospitalized with a diagnosis of missed abortion\n\nGestational age of 10 weeks or less\n\nMentally healthy and able to communicate\n\nAble to read, understand, and speak Turkish\n\nLiterate\n\nWilling to participate and provide written informed consent\n\nExcluPhysical limitations preventing participation in the coloring activity\n\nHistory of previous pregnancy loss\n\nPresence of chronic medical disease\n\nDiagnosis of a psychiatric disordersion Criteria:","FEMALE","18 Years",{"count":89,"type":90},126,"ESTIMATED","INTERVENTIONAL",[93],"NA","This randomized controlled study aims to evaluate the effects of mandala coloring activity on stress, anxiety, pain, and physiological parameters in women diagnosed with missed abortion. Participants will be randomly assigned to either a mandala coloring group or a control group receiving standard care. Outcomes will be measured at hospital admission and after completion of the mandala coloring session.",[96],"Missed Abortion",[96,98,99,100,101,102],"Mandala Coloring","Pregnancy Loss","Stress","Pain","Anxiety","2026-02-20",{"date":105,"type":106},"2026-02-24","ACTUAL",{"date":108,"type":106},"2025-10-30",{"date":110,"type":90},"2026-05",{"name":5,"class":6},1]