[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651704":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":65,"collaborators":69,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":25,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Beirut Arab University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-Tempo Music Intervention","EXPERIMENTAL","Participants will receive standard procedural sedation and will listen to low-tempo instrumental music (60-80 beats per minute) through headphones throughout the gastroscopy and\u002For colonoscopy. Before randomization, headphones will be tested using a standardized test audio and the volume will be adjusted to a comfortable level. During the procedure, a uniquely identified audio file containing the study music will be played by masked research personnel.",[13],"Other: Low-Tempo Instrumental Music",{"label":15,"type":16,"description":17,"interventionNames":18},"Silent Audio Control","SHAM_COMPARATOR","Participants will receive standard procedural sedation and will wear identical headphones throughout the gastroscopy and\u002For colonoscopy. Before randomization, headphones will be tested using the same standardized test audio and the volume will be adjusted to a comfortable level. During the procedure, a uniquely identified silent audio file will be played by masked research personnel. The audio player will progress in the same manner as in the intervention group.",[19],"Other: Silent Audio Control",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Low-Tempo Instrumental Music","Standardized instrumental music with a tempo of 60-80 beats per minute will be delivered through headphones during the endoscopic procedure. Playback will begin after application of the headphones and continue throughout the procedure. The intervention is provided in addition to standard procedural sedation.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"A silent audio file will be delivered through identical headphones during the endoscopic procedure. The file will play and progress in the same manner as the active music file but will contain no audible music. The control procedure is provided in addition to standard procedural sedation.",[15],[30],{"name":31,"affiliation":32,"role":33},"Bahaa W Bou Dargham, MD","Beirut Arab University \u002F Hammoud Hospital University Medical Center","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+961 3 537 986","bahaa_boudargham@hotmail.com",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Miralynn S Awwad","+961 76 329 066","msa172@student.bau.edu.lb",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":25,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Hammoud Hospital University Medical Center (HHUMC)","RECRUITING","Sidon","Lebanon","LB",{"type":51,"coordinates":52},"Point",[53,54],35.37148,33.55751,{"lat":54,"lon":53},[57,62,63],{"name":58,"role":36,"phone":59,"phoneExt":60,"email":61},"Ghada Aoun","+961 7 723 111","1956","medical@hhumc.org.lb",{"name":31,"role":33,"phone":25,"phoneExt":25,"email":25},{"name":40,"role":64,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Bahaa Bou Dargham","Anesthesia & Reanimation Consultant and Lecturer of Anesthesia",[70,73],{"name":71,"class":72},"Hammoud Hospital University Medical Center","OTHER_GOV",{"name":5,"class":6},"100651704","therapeutic-effects-of-music-on-procedural-outcomes-100651704",false,"NCT07763860","Therapeutic Effects of Music on Procedural Outcomes","Effect of Intra-Procedural Low-Tempo Instrumental Music Plus Standard Sedation Versus Standard Sedation Alone on Sedative Requirements in Adults Undergoing Gastroscopy and\u002For Colonoscopy: a Single-Center, Parallel-Group, Randomized Superiority Trial With Blinded Outcome Assessors and Statisticians","TEMPO","Inclusion Criteria:\n\n* Age ≥18 years.\n* Scheduled for elective gastroscopy (upper gastrointestinal endoscopy), colonoscopy, or both under procedural sedation.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Emergency or urgent endoscopic procedure.\n* Hearing impairment that prevents adequate perception of the standardized test audio through the study headphones.\n* American Society of Anesthesiologists (ASA) Physical Status IV or higher.\n* Cognitive impairment, altered mental status, or another condition that prevents provision of informed consent or reliable completion of study assessments.\n* Any condition that prevents safe or appropriate use of the study headphones.","ALL","18 Years",{"count":85,"type":86},180,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study will evaluate whether listening to low-tempo instrumental music during gastroscopy and\u002For colonoscopy can reduce the amount of sedative medication needed during the procedure. Adults undergoing elective gastroscopy and\u002For colonoscopy with sedation will be randomly assigned to one of two groups. One group will listen to low-tempo instrumental music (60-80 beats per minute) through headphones during the procedure in addition to receiving standard sedation. The other group will receive standard sedation without music.\n\nThe main outcome of the study is the amount of sedative medication required during the procedure. The study will also compare pain after the procedure, time until discharge, patient satisfaction, and changes in heart rate and blood pressure between the two groups. The researchers hypothesize that patients who listen to low-tempo music will require less sedative medication and may have improved recovery and patient-reported outcomes compared with patients receiving standard sedation alone.",[92,93,94],"Procedural Sedation","Gastrointestinal Endoscopy","Music Intervention",[96,97,98,99,92,100,101,102,103,104],"Music","Low-Tempo Music","Gastroscopy","Colonoscopy","Sedation","Propofol","Pain","Patient Satisfaction","Recovery Time","2026-08-09",{"date":107,"type":108},"2026-08-13","ACTUAL",{"date":110,"type":86},"2026-08",{"date":112,"type":86},"2026-10",{"name":67,"class":6},1]