[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590704":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":33,"locations":42,"responsibleParty":60,"collaborators":64,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":22,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":22,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":92,"whyStopped":22,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Ege University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Rhythm-Based Active Music Engagement Group","EXPERIMENTAL","Participants will engage in active rhythm-based music making sessions under the guidance of the researcher. Sessions will be conducted once daily for 3 consecutive days. Each session will last approximately 30 minutes and involve creating rhythms using hand drums and body percussion. Participants will follow simple rhythmic patterns designed to promote relaxation and engagement.",[13],"Behavioral: Rhythm-Based Music Intervention",{"label":15,"type":10,"description":16,"interventionNames":17},"Rhythm-Based Music Listening Group","Participants will passively listen to pre-recorded rhythm-based music selected by the researcher. Listening sessions will occur once daily for 3 consecutive days. Each session will last approximately 30 minutes. Participants will be seated comfortably and instructed to focus on the rhythm and flow of the music without actively creating sounds.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Control Group","NO_INTERVENTION","Participants in the control group will receive routine prenatal care without any additional music intervention during the study period.",null,[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":22},"BEHAVIORAL","Rhythm-Based Music Intervention","The rhythm-based music intervention is designed to reduce anxiety and improve emotional well-being in pregnant women with gestational diabetes. This intervention involves structured music sessions, utilizing rhythm as a therapeutic tool to engage participants in either active creation or passive listening. The intervention aims to promote relaxation, reduce stress, and support overall psychological health by leveraging the emotional and cognitive effects of rhythm and music.",[9,15],[30],{"name":31,"affiliation":5,"role":32},"Esin Ceber Turfan, Prof","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":22,"email":38},"Tuğba Yilmaz, MSc","CONTACT","+905356790850","tugbayilmaz101@gmail.com",{"name":31,"role":36,"phone":40,"phoneExt":22,"email":41},"+905369662353","esin.ceber@ege.edu.tr",[43],{"facility":44,"status":22,"city":45,"state":22,"zip":46,"country":47,"countryCode":22,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"İzmir City Hospital","Izmir","35000","Turkey (Türkiye)",{"type":49,"coordinates":50},"Point",[51,52],27.13838,38.41273,{"lat":52,"lon":51},[55,59],{"name":56,"role":36,"phone":57,"phoneExt":22,"email":58},"Atalay Ekin, Prof","+905357410380","atalay.ekin@sbu.edu.tr",{"name":31,"role":36,"phone":40,"phoneExt":22,"email":41},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Esin Ceber Turfan, Professor","Dean, Faculty of Health Sciences",[65],{"name":5,"class":6},"100590704","effects-of-rhythm-based-music-on-pregnancies-with-gestational-diabetes-100590704",false,"NCT06970886","Effects of Rhythm-Based Music on Pregnancies With Gestational Diabetes","Effects of Rhythm-Based Music on Anxiety, Glucose, and Cortisol in Pregnancies With Gestational Diabetes","Inclusion Criteria:\n\n* Voluntarily agree to participate in the study with informed written consent\n* Diagnosed with Gestational Diabetes Mellitus (GDM) and currently hospitalised\n* In the third trimester of pregnancy\n* Over the age of 18\n* Have a live, single fetus\n\nExclusion Criteria:\n\n* Any condition preventing participation in rhythm-based music making and listening (e.g., hearing, vision, or speech impairments)\n* Regular and routine music listening habits during pregnancy\n* Physical limitations or restrictions\n* Mental or cognitive disorders requiring medication\n* Use of corticosteroids or medications containing corticosteroids\n* Known fetal abnormalities\n* Systemic diseases other than GDM (e.g., Hypertension, Type 1 or Type 2 Diabetes, Thyroid disorders, etc.)\n* Body mass index (BMI) of 30 or higher\n* Discharge from the hospital before the 3rd day of the intervention",true,"FEMALE","18 Years","35 Years",{"count":78,"type":79},180,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study is for people who have gestational diabetes, a type of diabetes that happens during pregnancy. People with gestational diabetes may feel more anxious than others during pregnancy. This anxiety can affect their health and their baby's health.\n\nThe goal of this study is to see if rhythm-based music can help lower anxiety and improve blood sugar and stress hormone levels. Music may be a safe and low-cost way to support emotional and physical health during pregnancy.\n\nResearchers will test two types of music activities:\n\nListening to rhythm-based music\n\nDoing rhythm-based music and breathing exercises\n\nThe study will include 180 pregnant participants. They will be randomly placed into one of three groups. Each group will be at a different hospital to prevent crossover. Two groups will receive music activities, and the third group will receive usual care.\n\nParticipants will stay in the hospital for 3 days. During that time:\n\nAnxiety will be measured on day 1 and day 3 using a short questionnaire\n\nBlood sugar will be measured 3 times a day (morning, afternoon, evening)\n\nSaliva samples will be collected on day 3 to measure cortisol (a stress hormone)\n\nResearchers will also record any medications used by participants.\n\nThis study may show that music helps lower anxiety and improve health for people with gestational diabetes. It may also support the use of music as a helpful, non-drug option during pregnancy.",[85,86,87],"Gestational Diabetes Mellitus in Pregnancy","Anxiety","Blood Sugar; High",[86,89,90,91],"Blood glucose","Gestational diabetes","Salivary cortisol","NOT_YET_RECRUITING","2025-05-18",{"date":95,"type":96},"2025-05-22","ACTUAL",{"date":98,"type":79},"2025-09-01",{"date":100,"type":79},"2027-04-25",{"name":62,"class":6},1]