Effect of Intra-Procedural Low-Tempo Instrumental Music Plus Standard Sedation Versus Standard Sedation Alone on Sedative Requirements in Adults Undergoing Gastroscopy and/or Colonoscopy: a Single-Center, Parallel-Group, Randomized Superiority Trial With Blinded Outcome Assessors and Statisticians
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study will evaluate whether listening to low-tempo instrumental music during gastroscopy and/or colonoscopy can reduce the amount of sedative medication needed during the procedure. Adults undergoing elective gastroscopy and/or 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. The 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years.
• Scheduled for elective gastroscopy (upper gastrointestinal endoscopy), colonoscopy, or both under procedural sedation.
• Able to provide written informed consent.
Locations
Other Locations
Lebanon
Hammoud Hospital University Medical Center (HHUMC)
RECRUITING
Sidon
Contact Information
Primary
Bahaa W Bou Dargham, MD
bahaa_boudargham@hotmail.com
+961 3 537 986
Backup
Miralynn S Awwad
msa172@student.bau.edu.lb
+961 76 329 066
Time Frame
Start Date:2026-08
Estimated Completion Date:2026-10
Participants
Target number of participants:180
Treatments
Experimental: Low-Tempo Music Intervention
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/or 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.
Sham_comparator: Silent Audio Control
Participants will receive standard procedural sedation and will wear identical headphones throughout the gastroscopy and/or 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.