[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555289":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":36,"centralContacts":41,"locations":46,"responsibleParty":88,"collaborators":92,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":29,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":29,"enrollmentInfo":104,"targetDuration":29,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":115,"overallStatus":49,"whyStopped":29,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Sanitas University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Environmental Music Therapy","EXPERIMENTAL","Environmental Music Therapy (EMT) is a music therapy technique that uses live music to modulate the potentially stressful effects of the environment towards an atmosphere that provides a sense of comfort and security. The instruments used will be an acoustic guitar (Yamaha C-40), an ocean drum (a drum with a double skin on which small metal balls roll imitating the sound of the waves) and a Samafon (an instrument consisting of aluminum tubes of different sizes that are struck with a soft mallet producing long-lasting single or combined tones). The music will consist of improvised music at a slow to moderate tempo, using free-flowing melodies, and simple chord progressions, focusing on creating moments of tension and resolution. The music therapist will also use his\u002Fher voice, but without any lyrics or words. After approximately 20 minutes, the music therapist will gradually decrease the volume until the music stops.",[13],"Other: Environmental Music Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Pre-recorded music","The protocol for pre-recorded music is the same as for EMT, but instead of using live improvised music, a recording will be used that will consist of the same musical features and musical instruments as the live music. The recording will be made by the same music therapists who will perform the EMT intervention.",[18],"Other: Pre-recorded music",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard care only","PLACEBO_COMPARATOR","The control group will receive standard care in the emergency room waiting room as provided by each hospital, but without being exposed to EMT or pre-recorded music.",[24],"Other: Standard care only",[26,30,33],{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"The music will consist of improvised music at a slow to moderate tempo, using free-flowing melodies, and simple chord progressions, focusing on creating moments of tension and resolution during approximately 20 minutes.",[9],null,{"type":6,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"The protocol for pre-recorded music is the same as for EMT.",[15],{"type":6,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Standard care in the emergency room waiting room as provided by each hospital without being exposed to EMT or pre-recorded music.",[20],[37],{"name":38,"affiliation":39,"role":40},"Mark Ettenberger, PhD","keralty","PRINCIPAL_INVESTIGATOR",[42],{"name":38,"role":43,"phone":44,"phoneExt":29,"email":45},"CONTACT","+57 311 2847635","mark.ettenberger@gmx.at",[47,69],{"facility":48,"status":49,"city":50,"state":51,"zip":29,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Clínica Iberoamérica","RECRUITING","Barranquilla","Atlántico","Colombia","CO",{"type":55,"coordinates":56},"Point",[57,58],-74.78132,10.96854,{"lat":58,"lon":57},[61,62,65,67],{"name":38,"role":43,"phone":44,"phoneExt":29,"email":45},{"name":63,"role":64,"phone":29,"phoneExt":29,"email":29},"Ana Diaz","SUB_INVESTIGATOR",{"name":66,"role":64,"phone":29,"phoneExt":29,"email":29},"Raúl Suarez",{"name":68,"role":64,"phone":29,"phoneExt":29,"email":29},"Ornella Moreno",{"facility":70,"status":49,"city":71,"state":72,"zip":29,"country":52,"countryCode":53,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Clínica Keralty Ibagué","Ibague","Tolima Department",{"type":55,"coordinates":74},[75,76],-75.20289,4.43573,{"lat":76,"lon":75},[79,80,82,84,86],{"name":38,"role":43,"phone":44,"phoneExt":29,"email":45},{"name":81,"role":64,"phone":29,"phoneExt":29,"email":29},"Angélica Hernandez, MSc",{"name":83,"role":64,"phone":29,"phoneExt":29,"email":29},"Ana Moreno",{"name":85,"role":64,"phone":29,"phoneExt":29,"email":29},"Bryan Ríos",{"name":87,"role":64,"phone":29,"phoneExt":29,"email":29},"Alexandra Cristancho",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"SPONSOR_INVESTIGATOR","Claudia Aristizábal","Director",[93],{"name":5,"class":6},"100555289","music-therapy-and-pre-recorded-music-on-patients-and-caregivers-in-the-emergency-unit-100555289",false,"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,"ALL","18 Years",{"count":105,"type":106},243,"ESTIMATED","INTERVENTIONAL",[109],"NA","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.",[112,113,114],"Anxiety","Stress","Well-Being, Psychological",[116,117,112,113,118,119,120],"Music Therapy","Recorded Music","Wellbeing","Emergency Care","Waiting Room","2024-09-04",{"date":123,"type":124},"2024-09-19","ACTUAL",{"date":126,"type":124},"2024-07-31",{"date":128,"type":106},"2025-09-30",{"name":90,"class":6},2]