Music during endoscopy to reduce sedative need

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, parallel-group trial, adults undergoing elective gastroscopy and/or colonoscopy with sedation will be assigned to receive either low-tempo instrumental music through headphones in addition to standard sedation or standard sedation with a silent audio control. The primary outcome is the amount of sedative used during the procedure; secondary outcomes include post-procedure pain, time to discharge, patient satisfaction, and changes in heart rate and blood pressure. The music intervention is standardized at 60-80 beats per minute and is delivered during the endoscopic procedure. Sedation and other clinical care follow routine practice in both groups, with masking of audio conditions to minimize bias. The study aims to determine if non-pharmacologic music can improve the procedural experience and recovery without altering standard care.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hammoud Hospital University Medical Center (HHUMC)
  Sidon, Lebanon Recruiting

Study contacts

• Principal investigator: Bahaa W Bou Dargham, MD — Beirut Arab University / Hammoud Hospital University Medical Center
• Study coordinator: Bahaa W Bou Dargham, MD
• Email: bahaa_boudargham@hotmail.com
• Phone: +961 3 537 986

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.