Therapeutic Effects of Music on Procedural Outcomes

ConditionsProcedural Sedation Gastrointestinal Endoscopy Music Intervention

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBahaa Bou Dargham

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years.

Scheduled for elective gastroscopy (upper gastrointestinal endoscopy), colonoscopy, or both under procedural sedation.

Able to provide written informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Low-Tempo Instrumental Music
Other intervention
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 intervention
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.

Treatment groups

180 Participants

are divided into 2 treatment groups

Group A: Low-Tempo Music InterventionExperimental treatment 1 intervention

Group B: Silent Audio ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

Mean Total Propofol Dose Requirement During the Endoscopic Procedure

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.

Time frame

From first administration of procedural sedation until the end of the endoscopic procedure on the day of enrollment

Secondary outcomes

Mean Post-Procedural Pain Intensity on the 0-10 Numeric Rating Scale

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.

Time frame

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

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.

Time frame

From end of the endoscopic procedure until exit from the recovery room

Overall Patient Satisfaction With the Endoscopic 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.

Time frame

Before discharge from the recovery room on the day of the procedure

Requirement for Rescue Analgesia in the Recovery Room

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.

Time frame

From entry into the recovery room until recovery room discharge on the day of the procedure

Other outcomes

Mean Intra-Procedural Mean Arterial Pressure

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.

Time frame

From initiation of procedural sedation until the end of the endoscopic procedure, assessed at 10-minute intervals

Mean Intra-Procedural Heart Rate

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.

Time frame

From initiation of procedural sedation until the end of the endoscopic procedure, assessed at 10-minute intervals

Mean Intra-Procedural Peripheral Oxygen Saturation

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.

Time frame

From initiation of procedural sedation until the end of the endoscopic procedure, assessed at 10-minute intervals

Additional Patient Experience and Satisfaction Ratings

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.

Time frame

Before discharge from the recovery room on the day of the procedure