[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603673":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":31,"responsibleParty":49,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":18,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":18,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":79,"whyStopped":18,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Tunis El Manar","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Music group","EXPERIMENTAL","The intervention consists of music therapy administered during the latent and active phases of labor. Music is delivered through headphones or speakers and includes slow, instrumental, non-lyrical tracks (60-80 beats per minute), selected in collaboration with the participant. The intervention is applied for a minimum duration of 30 minutes and follows established clinical guidelines for therapeutic music use. Standard monitoring of maternal and fetal well-being is maintained throughout the intervention.",[13],"Other: Music Therapy During Labor",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","NO_INTERVENTION","This group received routine care during labor (monitoring of labor progression, vital signs, and fetal heart rate monitoring).\n\nNo specific pain management techniques were used for this group.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Music Therapy During Labor","This intervention involves the use of patient-selected, slow-tempo (60-80 bpm), non-lyrical instrumental music administered via headphones or speakers during the latent and active phases of labor. The music selection is guided to ensure therapeutic suitability (e.g., calming rhythm, absence of lyrics) and is delivered for a minimum of 30 minutes. The intervention is non-pharmacological, individualized, and adheres to WHO and clinical music therapy recommendations. It is distinguished by its personalized music choice, delivery timing, and structured application within labor progression monitoring.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"NESRINE SOUAYEH, Associate Professor","CONTACT","97816168","+216","nesrine.souayeh@fmt.utm.tn",[32],{"facility":33,"status":18,"city":34,"state":18,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Ben Arous regional Hospital","Ben Arous","2096","Tunisia","TN",{"type":39,"coordinates":40},"Point",[41,42],10.22167,36.75452,{"lat":42,"lon":41},[45,46],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},{"name":47,"role":48,"phone":18,"phoneExt":18,"email":18},"Oumaima Marzouki, Master's Student","PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Nesrine Souayeh","Associate Professor","100603673","music-therapy-for-labor-pain-and-anxiety-100603673",false,"NCT07139574","Music Therapy for Labor Pain and Anxiety","Impact of Music Therapy on Labor Pain and Anxiety: A Randomized Controlled Trial in Tunisian Women","Inclusion Criteria:\n\n* Married Tunisian women with a singleton, low-risk pregnancy.\n* Admitted in the latent phase of spontaneous labor, as diagnosed by a midwife or resident.\n* Planned vaginal delivery.\n* Parity \\\u003C 4.\n* Gestational age between 37 and 41 weeks of amenorrhea.\n* Attended at least 4 prenatal consultations.\n* Normal physical and mental health status.\n* No known fetal anomalies.\n* Estimated fetal weight between 2500-4000 g.\n* Cephalic presentation.\n* Normal fetal heart rate and uterine contraction tracings.\n* Able to read, write, and understand study-related information.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Women who received epidural analgesia during labor.\n* Presence of auricular malformations.\n* Difficulty in understanding or completing the VAS or STAI-Y assessments.\n* Serious medical or psychiatric disorders.\n* Multiple gestation or pregnancies requiring immediate intervention.\n* Preterm (\\\u003C37 weeks) or post-term (\\>41 weeks) pregnancies.\n* Premature rupture of membranes.\n* Clinical chorioamnionitis or other infections (including HIV).\n* History of severe obstetric complications (e.g., cephalopelvic disproportion, intrauterine fetal death )",true,"FEMALE","18 Years","45 Years",{"count":64,"type":65},70,"ESTIMATED","INTERVENTIONAL",[68],"NA","This multicenter randomized controlled trial evaluates the effectiveness of music therapy in reducing pain and anxiety during the latent and active phases of labor in Tunisian women. Participants are randomized to receive either music therapy or standard care. Primary outcomes are pain (VAS) and anxiety (STAI-Y). Secondary outcomes include labor duration, maternal and fetal vital signs, neonatal outcomes, and maternal satisfaction.",[71,72],"Labor Pain","Anxiety",[74,75,76,77,78],"music therapy","anxiety","pain management","labor","randomized controlled trial","NOT_YET_RECRUITING","2025-08-17",{"date":82,"type":83},"2025-08-24","ACTUAL",{"date":85,"type":65},"2025-09",{"date":87,"type":65},"2025-11",{"name":5,"class":6},1]