[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Claudia Aristizábal\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":173},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,49,72,100,122,151],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100561543","the-effect-of-music-therapy-on-vital-signs-and-heart-rate-variability-of-pediatric-patients-during-the-extubation-process-100561543",false,"NCT06591533","The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.","The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process in the Pediatric Intensive Care Unit","Inclusion Criteria:\n\n* Pediatric patients hospitalized who are undergoing an extubation process.\n\nExclusion Criteria:\n\n* Pediatric patients with accidental extubation will be excluded.","ALL","1 Month","17 Years",{"count":20,"type":21},82,"ESTIMATED","INTERVENTIONAL",[24],"NA","The extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety, or discomfort in the patients, which results in an increased likelihood of reintubation. Music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients, but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking.\n\nThe aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia.\n\nThis study is a Randomized clinical trial (RCT) with two parallel arms. The intervention group (IG) will receive standard care during the extubation process + music therapy and the control group (CG) will receive standard care only. The primary outcome measure is heart rate (HR) measured every minute for 5 minutes before extubation, during extubation, and up to 10 minutes after extubation. Secondary measures are: oxygen saturation, respiratory rate, blood pressure, duration of the procedure, number of reintubations, and heart rate variability.",[27,28],"Respiratory Failure","Intensive Care Pediatric",[30,31,32,33,34,35],"vital signs","Pediatric Intensive Care Unit","extubation","music therapy","mechanical ventilation","hear rate","RECRUITING","2025-09-19",{"date":39,"type":40},"2025-09-24","ACTUAL",{"date":42,"type":40},"2025-09-01",{"date":44,"type":21},"2026-12-31",{"name":46,"class":47},"Claudia Aristizábal","OTHER",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100587964","steri-strip-tape-use-in-unilateral-ectropion-surgery-100587964","NCT06935227","Steri-Strip Tape Use in Unilateral Ectropion Surgery","Postoperative Outcomes of Steri-Strip Surgical Tape Use in Unilateral Ectropion Surgery: A Parallel-Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients aged 18 years or older who are scheduled to undergo unilateral ectropion surgery.\n\nExclusion Criteria:\n\n* Underlying conditions associated with skin hyperlaxity, such as cutis laxa and Ehlers-Danlos syndrome.\n* Skin diseases that predispose to cicatricial ectropion, such as ichthyosis, scleroderma, and psoriasis.\n* Paralytic ectropion.\n* Current use of oral isotretinoin.","18 Years",{"count":58,"type":21},74,[24],"Currently, the incidence of involutional and chronic eyelid disorders, such as ectropion, has been increasing, as human life expectancy has risen worldwide (more than 600 million people are aged ≥ 60 years). Ectropion is a common eyelid malposition that causes visual morbidity. It is characterized by eversion of the eyelid margin and has multiple etiologies.\n\nSteri-Strip tapes have been used in some ophthalmologic procedures, such as blepharoplasties, where they help prevent infections by acting as a barrier method, are resistant enough to reduce the risk of wound dehiscence, simplify postoperative care, and allow for proper eyelid fissure closure. Their use has been recommended in patients with facial paralysis to prevent keratitis or exposure ulcers. However, current evidence is limited, as their use has only been documented in case series and letters to the editor. Therefore, a randomized controlled clinical trial is proposed to evaluate the postoperative outcomes of Steri-Strip tape use in unilateral ectropion surgery compared to standard postoperative management.",[62],"Ectropion","2025-06-06",{"date":65,"type":40},"2025-06-11",{"date":67,"type":40},"2025-05-01",{"date":69,"type":21},"2026-02",{"name":46,"class":47},1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100566347","feasibility-and-safety-of-early-mobilization-and-rehabilitation-in-intensive-care-unit-patients-100566347","NCT06653998","Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients","Feasibility and Safety of Early Mobilization and Rehabilitation in Intensive Care Unit Patients. A Prospective, Multicenter Study","Inclusion Criteria:\n\n* Patients ≥ 18 years of age admitted to the intensive care units.\n\nExclusion Criteria:\n\n* Patients requiring extracorporeal membrane oxygenation (ECMO).\n* Patients without indication for early mobilisation in the ICU (severe hemodynamic instability, acute brain or spinal injury with rest orders, anaemia (Hb \\<8 mg\u002Fdl), thrombocytopenia (platelets \\<50,000), active systemic inflammatory response according to institutional protocols).\n* Patients in the postoperative period of cardiac transplantation.",{"count":80,"type":21},220,"OBSERVATIONAL","Intensive Care Unit Acquired Weakness (ICU-AW) is a common complication of critical illnesses, occurring in approximately 50% of ICU patients and is strongly associated with increased morbidity, physical impairments, and both short- and long-term mortality. The main characteristics of ICU-AW are symmetrical generalised muscle weakness affecting both respiratory and limb muscles; however, the clinical phenotype may differ depending on age, disease burden, length of ICU stay, and mechanical ventilation duration.\n\nThe objective of the present study is to evaluate the feasibility achieved and the safety outcomes reported in a cohort of critically ill patients who undergo early mobilisation and rehabilitation in intensive care units. This research is a multicentre prospective cohort study.",[84,85],"Intensive Care Unit Acquired Weakness","Intensive Care Unit Patients",[87,88,89,90],"Intensive Care Units","Muscle Weakness","Early Mobilization","Rehabilitation","2024-10-21",{"date":93,"type":40},"2024-10-23",{"date":95,"type":40},"2024-05-10",{"date":97,"type":21},"2025-04",{"name":46,"class":47},4,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},"100548599","music-therapy-songwriting-and-mental-health-in-neonatel-intensive-care-unit-nicu-parents-100548599","NCT06423092","Music Therapy Songwriting and Mental Health in Neonatel Intensive Care Unit (NICU) Parents","Short-term Effectiveness of Music Therapy Songwriting on Mental Health Outcomes of At-risk Parents in the Neonatal Intensive Care Unit: an International Multicenter Mixed-methods Study.","Inclusion Criteria:\n\n* The study population consisted of parents\u002Fcaregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected hospitalizations of at least three weeks. In the case of a twin pregnancy, the firstborn infant was randomly assigned to one of the intervention groups, while both infants received the same treatment according to the outcome of randomization.\n* Mother a total score of ≥10 and\u002For father a total score of ≥7 on the EPDS (Edinburgh Postnatal Depression Scale)\n* Mother and\u002For father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale)\n\nExclusion Criteria:\n\n* Parents\u002Fcaregivers with known auditory problems that prevent participation in MT.\n\nMoreover parents\u002Fcaregivers with a documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments.\n\n* Parents\u002Fcaregivers of premature infants in palliative or end-of-life care, infants with known hearing impairment, or infants in the custody of social services.",{"count":108,"type":21},102,[24],"The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health.\n\nThe main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.",[112],"Mental Health Impairment","2024-09-06",{"date":115,"type":40},"2024-09-19",{"date":117,"type":40},"2024-07-30",{"date":119,"type":21},"2026-06",{"name":46,"class":47},5,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":138,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":48},"100555289","music-therapy-and-pre-recorded-music-on-patients-and-caregivers-in-the-emergency-unit-100555289","NCT06510153","Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit","Effect of Live Environmental Music Therapy and Pre-recorded Music on State-Anxiety, Stress, Pain, and Wellbeing Levels of Patients and Caregivers in the Emergency Unit Waiting Area: A Multi-Center Randomized Clinical Trial Study Protocol","Inclusion Criteria:\n\n* Patients and caregivers\u002Fcompanions of legal age present in the emergency waiting room present during the intervention and control conditions.\n* Patients whose triage does not represent immediate threat to life or severely ill patients (i.e., triage 3, 4 and 5)\n* Patients and caregivers\u002Fcompanions with literacy skills.\n\nExclusion Criteria:\n\n* Patients and caregivers\u002Fcompanions who report having hearing problems\n* Patients and caregivers\u002Fcompanions with difficulties in understanding and\u002For filling out the questionnaires.\n* Patients and\u002For caregivers\u002Fcompanions who do not consent to participate in the study.",true,{"count":131,"type":21},243,[24],"Patients and caregivers attending emergency units often experience elevated levels of stress and anxiety. Music has been used in waiting rooms to reduce stress and anxiety, but existing studies on music in emergency unit waiting areas are scarce and have limitations such as low statistical power and limited music selection. The aim of this study is to determine the effect of live Environmental Music Therapy (EMT) and pre-recorded music on state-anxiety, stress, pain and well-being levels in patients and caregivers in the emergency unit waiting areas of two hospitals in Colombia.\n\nThis study is a multi-center randomized clinical trial, with three arms: standard care + live EMT, standard care + pre-recorded music, and standard care only. The primary outcome measure is the six-item State-Trait Anxiety Inventory (STAI-6). Secondary outcome measures are pain and stress levels, both measured with a Visual Analogue Scales (VAS), and well-being, measured with the Well-Being Numerical Rating Scales (WB-NRSs). The scales will be applied before and after each intervention.\n\nThis study seeks to contribute to improving mental health, wellbeing, and quality of care of patients and caregivers in the waiting area of the emergency units. This is the first study in Colombia investigating the effect live music therapy and pre-recorded music interventions in the emergency department.",[135,136,137],"Anxiety","Stress","Well-Being, Psychological",[139,140,135,136,141,142,143],"Music Therapy","Recorded Music","Wellbeing","Emergency Care","Waiting Room","2024-09-04",{"date":115,"type":40},{"date":147,"type":40},"2024-07-31",{"date":149,"type":21},"2025-09-30",{"name":46,"class":47},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":165,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":172,"locationsCount":71},"100560452","music-therapy-on-state-anxiety-levels-and-well-being-during-chemotherapy-100560452","NCT06577324","Music Therapy on State Anxiety Levels and Well-being During Chemotherapy","Effect of a Single Session of Live Group Music Therapy on State Anxiety Levels and Well-being During Chemotherapy: A Multicenter Randomized Clinical Trial","Inclusion Criteria:\n\n* Patients with a cancer diagnosis, attending intravenous chemotherapy sessions at the Sebastián de Belalcázar and del Carmen clinics.\n* Patients over 18 years old.\n* Patients who have never previously received music therapy.\n* Patients with literacy skills.\n\nExclusion Criteria:\n\n* Patients who report having hearing problems.\n* Patients who express a desire not to participate in the study.\n* Patients with difficulties understanding and completing questionnaires.",{"count":108,"type":21},[24],"Introduction: Many cancer patients experience high levels of anxiety during chemotherapy, which can negatively impact their mental health and physiological, emotional, and spiritual well-being. Various complementary therapies exist to mitigate these effects, including music therapy. Although preliminary evidence supports the positive effects of music therapy and music-based interventions in chemotherapy, few studies report live group interventions conducted by accredited music therapists.\n\nObjective: To determine the effect of a single session of live group music therapy on state anxiety levels and well-being in adult cancer patients undergoing chemotherapy.\n\nMethodology: This study is a multicenter, randomized clinical trial with two arms. The intervention group will receive standard care plus a live group music therapy session, while the control group will receive standard care only. The primary outcome measure is the State-Trait Anxiety Inventory (STAI-E), and the secondary outcome measure is well-being, assessed using the Well-being Numerical Rating Scales (WB-NRSs). The scales will be administered before and after each intervention. The sample size is 102 patients.\n\nExpected Results: This study aims to improve the psycho-emotional health and well-being of cancer patients during chemotherapy, thereby enhancing the quality of care.",[162,137],"Anxiety State",[135,164,139],"Well-Being","NOT_YET_RECRUITING","2024-08-27",{"date":168,"type":40},"2024-08-29",{"date":170,"type":21},"2024-09-01",{"date":42,"type":21},{"name":46,"class":47},""]