Therapeutic Effects of Music on Procedural Outcomes

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.

Before the procedure, baseline demographic and clinical information, and vital signs will be recorded. During the procedure, sedative medication use and physiologic parameters will be documented. Following the procedure, recovery and patient-reported outcomes will be assessed, including pain, satisfaction with the endoscopic experience, and time to discharge. The primary objective is to determine whether intra-procedural exposure to low-tempo instrumental music reduces sedative medication requirements compared with standard sedation alone. Secondary analyses will evaluate postoperative pain, recovery time, patient satisfaction, and physiologic outcomes.

Research personnel responsible for postoperative outcome assessment will remain unaware of treatment allocation. Participants will be instructed not to disclose whether they heard music during the procedure until all masked postoperative outcome assessments have been completed. Outcome assessors will not ask participants questions that could reveal their allocation before these assessments are completed. The statistical analysis will also be conducted using coded treatment groups, with the treatment code withheld from the statistician until the prespecified analysis has been completed.

Because participants may perceive whether music was present during the procedure, participant masking cannot be guaranteed despite the identical headphone setup and standardized procedures used in both groups. The masking strategy is primarily designed to prevent investigators, personnel responsible for intervention delivery, postoperative outcome assessors, and the statistician from knowing treatment allocation during the relevant stages of the trial.

The study is being conducted at Hammoud Hospital University Medical Center (HHUMC) in Saida, Lebanon. The music intervention does not replace or modify standard procedural sedation and is evaluated as an adjunct to usual endoscopic care. The findings may help determine whether a simple, inexpensive, and readily implementable intervention can reduce sedative requirements and improve recovery and patient-centered outcomes in adults undergoing gastrointestinal endoscopy.

• Low-Tempo Instrumental Music (Other): 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.
• Silent Audio Control (Other): 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.

Primary outcomes

• Mean Total Propofol Dose Requirement During the Endoscopic Procedure [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]: Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Mean NRS scores will be compared between randomized groups at each prespecified post-procedure assessment.
• Mean Time From End of Procedure to Recovery Room Discharge [From end of the endoscopic procedure until exit from the recovery room]: Recovery time will be calculated in minutes from the end of the endoscopic procedure, defined as the time the participant is detached from procedural monitoring, until the participant exits the recovery room. Mean recovery time will be compared between randomized groups.
• Overall Patient Satisfaction With the Endoscopic Procedure [Before discharge from the recovery room on the day of the procedure]: Overall patient satisfaction will be assessed using the custom item, "Overall, I am satisfied with the procedure I underwent." Responses will be recorded on a 4-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = agree, and 4 = strongly agree. Higher scores indicate greater satisfaction.
• Requirement for Rescue Analgesia in the Recovery Room [From entry into the recovery room until recovery room discharge on the day of the procedure]: The requirement for rescue analgesia will be assessed from entry into the recovery room until recovery room discharge. The proportion of participants receiving at least one analgesic medication for post-procedural pain will be compared between the randomized groups. The analgesic medication administered and its dose will also be recorded.

Other outcomes

• Mean Intra-Procedural Mean Arterial Pressure [From initiation of procedural sedation until the end of the endoscopic procedure, assessed at 10-minute intervals]: Mean arterial pressure (MAP) will be calculated from systolic and diastolic blood pressure measurements. MAP will be recorded at prespecified 10-minute intervals during the endoscopic procedure. For each participant, the mean of all scheduled intra-procedural MAP measurements will be calculated, and participant-level mean MAP will be compared between the randomized groups. MAP will also be compared between groups at prespecified measurement time points.
• Mean Intra-Procedural Heart Rate [From initiation of procedural sedation until the end of the endoscopic procedure, assessed at 10-minute intervals]: Heart rate will be recorded at prespecified 10-minute intervals during the endoscopic procedure. For each participant, the mean of all scheduled intra-procedural heart rate measurements will be calculated, and participant-level mean heart rate will be compared between the randomized groups. Heart rate will also be compared between groups at prespecified measurement time points.
• Mean Intra-Procedural Peripheral Oxygen Saturation [From initiation of procedural sedation until the end of the endoscopic procedure, assessed at 10-minute intervals]: Peripheral oxygen saturation (SpO₂) will be recorded at prespecified 10-minute intervals during the endoscopic procedure. For each participant, the mean of all scheduled intra-procedural SpO₂ measurements will be calculated, and participant-level mean SpO₂ will be compared between the randomized groups. SpO₂ will also be compared between groups at prespecified measurement time points.
• Additional Patient Experience and Satisfaction Ratings [Before discharge from the recovery room on the day of the procedure]: Additional aspects of the patient experience will be assessed using custom, non-validated 4-point Likert items. Participants will rate: comfort during the procedure; satisfaction with the level of sedation received; feeling safe and well cared for by the healthcare team; satisfaction with the overall hospital experience; and willingness to undergo the same procedure again if needed. Each item will be scored from 1 = strongly disagree to 4 = strongly agree, with higher scores indicating a more favorable experience. Each item will be analyzed separately; no composite score will be calculated.
• Proportion of Participants Experiencing Sedation-Related Intra-Procedural Adverse Events [From first administration of procedural sedation until the end of the endoscopic procedure]: Proportion of participants experiencing at least one prespecified sedation-related adverse event during the endoscopic procedure. Events assessed will include apnea, hypotension, bradycardia, and requirement for vasopressor treatment.

Sex: All, ages: 18 Years to any

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.

• Bahaa W Bou Dargham, MD, Principal investigator, Beirut Arab University / Hammoud Hospital University Medical Center