[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529506":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":40,"studyPopulation":32,"armGroups":41,"interventions":52,"overallOfficials":32,"centralContacts":57,"locations":66,"responsibleParty":84,"collaborators":32,"id":88,"slug":32,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":32,"enrollmentInfo":96,"targetDuration":32,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":32,"overallStatus":69,"whyStopped":32,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Universiteit Antwerpen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":32},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"pain perception level","Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level","Ten minutes before mobilization begins and ten minutes after mobilization is completed",{"measure":14,"description":15,"timeFrame":12},"stress perception level","Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's stress level.",{"measure":17,"description":18,"timeFrame":12},"anxiety perception level","Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's anxiety level.",[20,23,26,29],{"measure":21,"description":22,"timeFrame":12},"Time of mobilization","Time in minutes of mobilization",{"measure":24,"description":25,"timeFrame":12},"Blood pressure","Systolic Blood Pressure",{"measure":27,"description":28,"timeFrame":12},"Heart rate","Heart frequency per minute",{"measure":30,"description":31,"timeFrame":12},"Respiratory frequency","Respiratory frequency per minute",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","PARALLEL","Randomized controlled trial (RCT) with parallel arms: control and intervention group. Not blinded.","SUPPORTIVE_CARE",{"masking":39,"maskingDescription":32,"whoMasked":32},"NONE","There is a paucity of literature on the use of music therapy ('music care') in intensive care units (ICUs) during the process of mobilization. However, research suggests that mobilization can reduce the risk of depression and improve cognitive function (Chiang et al., 2006). This study aims to investigate the impact of music therapy on procedural comfort during sit-to-stand mobilization in ICU patients.\n\nSpecifically, the investigators seek to examine the effects of music therapy on pain perception, stress levels, anxiety levels, and vital parameters (blood pressure, heart rate, and respiratory rate) during this procedure. The investigators hypothesize that music therapy can improve procedural comfort by reducing pain, stress, and anxiety.\n\nThis study employs quantitative multicenter research, specifically a randomized controlled trial (RCT), involving ICU patients at three hospitals: AZ Monica Deurne, GZA campus Sint-Augustinus, and Sint-Vincentius.\n\nDuring the intervention, patients will listen to their preferred music through noise-canceling headphones. Patients will be able to select their preferred music.\n\nTo assess the effects of music therapy, the investigators developed a self-designed measurement tool, validated using content validation indices (CVI) with an expert panel including pain nurses. The tool measures various indicators, including:\n\nVital parameters: (arterial) blood pressure, heart rate, and respiratory rate\n\nPain perception: Using an 11-point Likert scale from 0 to 10, nurses will assess the patient's pain level. Zero indicates no pain, while 10 represents the worst imaginable pain.\n\nAnxiety and stress levels: Nurses will utilize 11-point Likert scales from 0 to 10 to measure the patient's anxiety and stress levels. The sum of these three scores will provide an overall measure of procedural distress.\n\nTo assess the duration of the effects of music therapy, we will record the above indicators at four time points:\n\nTime 0: Ten minutes before sit-to-stand mobilization begins\n\nTime 1: Ten minutes after sit-to-stand mobilization is completed\n\nTime 2: Immediately before returning the patient to bed, after music stops\n\nTime 3: Ten minutes after the patient is back in bed\n\nDelta calculations will be performed to measure changes between time points.\n\nThe selected music playlist will be briefly noted on the measurement tool, and a final Likert scale will assess patient satisfaction with the intervention.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"Music","EXPERIMENTAL","Music through noise cancelling headphones.",[47],"Device: Music",{"label":49,"type":50,"description":51,"interventionNames":32},"No music","NO_INTERVENTION","Control group receiving regular care. No music will be offered to the patient.",[53],{"type":54,"name":43,"description":55,"armGroupLabels":56,"otherNames":32},"DEVICE","The patient can decide the music genre (a standard playlist) and receives a noise-cancelling headphone playing the chosen music during mobilization.",[43],[58,63],{"name":59,"role":60,"phone":61,"phoneExt":32,"email":62},"Lotte Heirbaut, RN","CONTACT","003232659169","lotte.heirbaut@student.uantwerpen.be",{"name":64,"role":60,"phone":61,"phoneExt":32,"email":65},"Filip Haegdorens, PhD","filip.haegdorens@uantwerpen.be",[67],{"facility":68,"status":69,"city":70,"state":71,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"University of Antwerp","RECRUITING","Wilrijk","Antwerp","2610","Belgium","BE",{"type":76,"coordinates":77},"Point",[78,79],4.39513,51.16734,{"lat":79,"lon":78},[82],{"name":64,"role":60,"phone":83,"phoneExt":32,"email":65},"0032497769040",{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Filip Haegdorens","Assistant professor","100529506",false,"NCT06174662","The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial","MUSICU","Inclusion Criteria:\n\n* They are admitted to the ICU\n* They have a Richmond Agitation-Sedation Scale (RASS) score of +1, 0, or -1\n* They are able to speak Dutch\n\nExclusion Criteria:\n\n* They are younger than 18 years old\n* They have a hearing impairment\n* They are in isolation\n* They have a cranial dressing or intracranial pressure monitoring","ALL","18 Years",{"count":97,"type":98},128,"ESTIMATED","INTERVENTIONAL",[101],"NA","This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU).",[104,105,106],"Pain","Stress","Anxiety","2024-07-01",{"date":109,"type":110},"2024-07-03","ACTUAL",{"date":112,"type":110},"2024-02-02",{"date":114,"type":98},"2025-05-31",{"name":5,"class":6},1]