Therapeutic Effects of Music on Procedural Outcomes

NCT07763860 | Recruiting

• 1 other identifier: IRB-July2026-VII
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Sedation; Gastrointestinal Endoscopy; Music Intervention

Keywords

Music; Low-Tempo Music; Gastroscopy; Colonoscopy; Procedural Sedation; Sedation; Propofol; Pain; Patient Satisfaction; Recovery Time

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (4)

• 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

Other Outcomes (5)

• Mean Intra-Procedural Mean Arterial Pressure

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

• Mean Intra-Procedural Heart Rate

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

• Mean Intra-Procedural Peripheral Oxygen Saturation

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

Study Arms (2)

Low-Tempo Music Intervention

EXPERIMENTAL

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.

Other: Low-Tempo Instrumental Music

Silent Audio Control

SHAM COMPARATOR

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.

Other: Silent Audio Control

Interventions

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.

Low-Tempo Music Intervention

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.

Silent Audio Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Scheduled for elective gastroscopy (upper gastrointestinal endoscopy), colonoscopy, or both under procedural sedation.
• Able to provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahaa Bou Dargham: lead
• Beirut Arab University: collaborator
• Hammoud Hospital University Medical Center: collaborator

Study Sites (1)

Hammoud Hospital University Medical Center (HHUMC)

Sidon, Lebanon

RECRUITING

MeSH Terms

Conditions

Pain; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Bahaa W Bou Dargham, MD

  Beirut Arab University / Hammoud Hospital University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahaa W Bou Dargham, MD

CONTACT

+961 3 537 986; bahaa_boudargham@hotmail.com

Miralynn S Awwad

CONTACT

+961 76 329 066; msa172@student.bau.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesia & Reanimation Consultant and Lecturer of Anesthesia

Model Details: Participants will be randomized in a 1:1 ratio to two parallel groups: low-tempo instrumental music (60-80 beats per minute) delivered through headphones during the endoscopic procedure in addition to standard sedation, or a control group receiving standard sedation with an identically administered silent audio file through headphones. Each participant will remain in the assigned group for the duration of the study.

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start: August 1, 2026
• Primary Completion: October 1, 2026
• Study Completion: October 1, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)