The Effect of Music During Colonoscopy

NCT07454993 | Recruiting

• 1 other identifier: 25/60167
• Study Type: interventional
• Target: 1,042
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is an important examination used to diagnose conditions such as inflammatory bowel disease and colorectal cancer and plays a central role in colorectal cancer screening programs. Although colonoscopy is a routine and generally safe procedure, many patients experience pain, discomfort, and anxiety during the examination. Approximately 25-30% of patients report moderate to severe pain. Fear of discomfort is also a known barrier to participation in colonoscopy, particularly in screening settings. Sedatives and pain-relieving medications are commonly used during colonoscopy to reduce discomfort. However, medication does not completely eliminate pain or anxiety for all patients. Therefore, it is important to investigate non-pharmacological interventions that may improve patient comfort without adding risk. Listening to music has been shown in various medical settings to reduce stress, anxiety, and perceived pain. Some previous studies have suggested that music during colonoscopy may reduce pain and anxiety, but results have been inconsistent and many studies have included relatively small numbers of participants. Larger, well-designed randomized trials are needed to clarify whether music has a meaningful clinical effect during colonoscopy. The aim of this study is to investigate whether playing music during colonoscopy reduces patient-reported pain. This study is a single-center, randomized controlled clinical trial. Patients scheduled for ambulatory colonoscopy will be randomly assigned in a 1:1 ratio to either colonoscopy with music (intervention group) or colonoscopy without music (control group). Randomization will be performed using variable block sizes to ensure balanced allocation between groups. In the intervention group, pop and rock music from a pre-designed playlist will be played from the start to the end of the colonoscopy. The music will be clearly audible but will not interfere with communication between the patient and healthcare staff. The volume may be adjusted as needed, and the music can be turned off at any time at the request of the patient or staff. Apart from the presence or absence of music, the colonoscopy procedure will be performed according to standard practice in both groups. There will be no changes to sedation, monitoring, or medical treatment as part of the study. Data will be collected prospectively in two ways. During the procedure, healthcare staff will record procedure-related information, including medications administered and their assessment of the patient's pain using a numeric rating scale (0-10). After the procedure, and before discharge, patients will complete a short electronic questionnaire, also rating their pain on a 0-10 numeric rating scale. The questionnaire will be completed regardless of whether the procedure was fully completed or what findings were observed. The study plans to include a total of 1,042 participants (521 in each group). The primary outcome is the difference in patient-reported pain between colonoscopy performed with music and colonoscopy performed without music. Playing music during colonoscopy is considered a low-risk intervention. If a patient finds the music uncomfortable or disturbing, it will be stopped immediately. Participation in the study will not otherwise affect the patient's treatment or care. If music is shown to reduce pain during colonoscopy, it may represent a simple, inexpensive, and easily implementable method to improve patient comfort during this common procedure.

Conditions

Pain; Pain Management

Keywords

pain; colonoscopy; music; procedural pain; pain management; colorectal cancer screening

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Pain During Colonoscopy

  Pain intensity measured using a Numeric Rating Scale (NRS) from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain. The score is reported by the participant using an electronic questionnaire completed after the procedure.

  Immediately after the procedure, before discharge from the endoscopy unit (minimum 15 minutes after procedure completion)

Secondary Outcomes (2)

• Were the patients aware that music was being played during the colonoscopy

  Immediately after the procedure, before discharge from the endoscopy unit (minimum 15 minutes after procedure completion)

• Would the patients prefer to have music during a future colonoscopy?

  Immediately after the procedure, before discharge from the endoscopy unit (minimum 15 minutes after procedure completion)

Study Arms (2)

Music during colonoscopy

EXPERIMENTAL

Playback of pre-selected pop and rock music via speaker in the procedure room throughout colonoscopy.

Other: Music intervention

Standard Colonoscopy (No Music)

NO INTERVENTION

Participants undergo colonoscopy according to standard practice without music played during the procedure.

Interventions

Music intervention OTHER

Playback of pre-selected pop and rock music from a standardized playlist during the entire colonoscopy procedure. The music is delivered via speaker in the procedure room at a volume that allows normal communication between patient and healthcare staff. The volume may be adjusted, and the music may be discontinued at any time upon request.

Music during colonoscopy

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Scheduled for ambulatory (outpatient) colonoscopy
• Able to provide written informed consent
• Able to understand and read Danish

You may not qualify if:

• Planned colonoscopy under propofol sedation or general anesthesia
• Planned endoscopic mucosal resection (EMR)

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead

Study Sites (1)

Esbjerg Hospital, University Hospital of Southern Denmark

Esbjerg, Region Syd, 6700, Denmark

RECRUITING

MeSH Terms

Conditions

Pain; Agnosia; Pain, Procedural

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Magnus Ploug, MD, PhD

  Institute of Regional Health Research, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Ploug, MD, PhD

CONTACT

26175029; magnus.ploug@rsyd.dk

Ulrik Lyngsø Madsen, MD

CONTACT

79184000; Ulrik.Lyngso.Madsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: March 6, 2026
• Study Start: March 12, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)