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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Mean Total Propofol Dose Requirement During the Endoscopic Procedure
Study Overview
Brief 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.
Detailed Description
Gastroscopy and colonoscopy are commonly performed procedures that may be associated with anxiety, discomfort, and the need for procedural sedation. Greater exposure to sedative medications may contribute to delayed recovery and sedation-related adverse effects. Non-pharmacological interventions that promote relaxation and improve patient comfort may therefore be useful adjuncts to routine endoscopic care. Music is a simple, low-cost intervention that may reduce physiologic arousal and improve the procedural experience. Low-tempo instrumental music can also be standardized and delivered without interfering with routine clinical care.
TEMPO is a single-center, randomized, parallel-group superiority trial evaluating the effect of intra-procedural low-tempo instrumental music in adults undergoing elective gastroscopy and/or colonoscopy with sedation. Participants will be randomly assigned in a 1:1 ratio to either low-tempo instrumental music in addition to standard sedation or standard sedation alone. In the intervention group, instrumental music with a tempo of 60-80 beats per minute will be delivered through headphones during the endoscopic procedure. In the control group, participants will wear the same headphones and an assigned silent audio file will be played. Sedation and all other aspects of clinical care will otherwise follow routine practice and clinical judgment in both groups.
A standardized masking procedure will be used for both groups. Before the procedure, all participants will have headphones applied and a short test audio will be played to confirm that the headphones are functioning correctly and to adjust the volume to a comfortable level. This pre-procedure test will be performed before the participant's treatment allocation is revealed through the study system.
Randomization and allocation concealment will be managed independently from participant enrollment and intervention delivery. The allocation sequence and the correspondence between study participants, treatment groups, and assigned audio files will be maintained by an independent individual who is not involved in participant recruitment, intervention delivery, outcome assessment, or statistical analysis. Research personnel enrolling participants will not have access to the allocation sequence.
At the time of study enrollment, the researcher will access a dedicated study platform and obtain an audio file assigned specifically to that participant. Each file will have a unique one-time identifier and filename. The researcher will download the assigned file, apply the headphones, and initiate playback without knowing whether the file contains low-tempo music or silence. For participants randomized to the intervention group, the file will contain the standardized low-tempo instrumental music. For participants randomized to the control group, the file will contain a silent audio track. Playback will appear and progress in the same manner in both groups. Unique filenames and identifiers will be used so that previous assignments cannot be used to infer current or future treatment allocation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants in both groups will undergo an identical headphone setup and pre-procedure test audio. After enrollment, a dedicated study platform will provide the investigator with a uniquely identified audio file corresponding to the randomized allocation. Investigators and care providers will not have access to the allocation sequence or know whether the assigned file contains low-tempo music or silence. The allocation sequence and audio-file mapping will be maintained by an independent individual not involved in enrollment, intervention delivery, outcome assessment, or analysis. Post-procedure outcome assessors will remain masked, and participants will be instructed not to disclose whether they heard music until all masked assessments are completed. Statistical analysis will be performed using coded groups, with the statistician masked to allocation until the prespecified analysis is completed.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years.
- •Scheduled for elective gastroscopy (upper gastrointestinal endoscopy), colonoscopy, or both under procedural sedation.
- •Able to provide written informed consent.
Exclusion Criteria
- •Emergency or urgent endoscopic procedure.
- •Hearing impairment that prevents adequate perception of the standardized test audio through the study headphones.
- •American Society of Anesthesiologists (ASA) Physical Status IV or higher.
- •Cognitive impairment, altered mental status, or another condition that prevents provision of informed consent or reliable completion of study assessments.
- •Any condition that prevents safe or appropriate use of the study headphones.
Arms & Interventions
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.
Intervention: Low-Tempo Instrumental Music (Other)
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.
Intervention: Silent Audio Control (Other)
Outcomes
Primary Outcomes
Mean Total Propofol Dose Requirement During the Endoscopic Procedure
Time Frame: From first administration of procedural sedation until the end of the endoscopic procedure on the day of enrollment
Total propofol dose administered to each participant during procedural sedation will be calculated as the cumulative dose administered from the start of sedation until the end of the gastroscopy and/or colonoscopy and normalized to body weight (mg/kg). The mean total propofol dose in mg/kg will be compared between the randomized groups.
Secondary Outcomes
- Mean Post-Procedural Pain Intensity on the 0-10 Numeric Rating Scale(10 minutes after entry to the recovery room and immediately before discharge from the recovery room)
- Mean Time From End of Procedure to Recovery Room Discharge(From end of the endoscopic procedure until exit from the recovery room)
- Overall Patient Satisfaction With the Endoscopic Procedure(Before discharge from the recovery room on the day of the procedure)
- Requirement for Rescue Analgesia in the Recovery Room(From entry into the recovery room until recovery room discharge on the day of the procedure)
Investigators
Bahaa Bou Dargham
Anesthesia & Reanimation Consultant and Lecturer of Anesthesia
Beirut Arab University