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.

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.