| NCT ID | NCT07454993 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Esbjerg Hospital - University Hospital of Southern Denmark |
| Condition | Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,042 participants |
| Start Date | 2026-03-12 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,042 participants in total. It began in 2026-03-12 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or older * Scheduled for ambulatory (outpatient) colonoscopy * Able to provide written informed consent * Able to understand and read Danish Exclusion Criteria: * Planned colonoscopy under propofol sedation or general anesthesia * Planned endoscopic mucosal resection (EMR)
Contact & Investigator
Magnus Ploug, MD, PhD
PRINCIPAL INVESTIGATOR
Institute of Regional Health Research, University of Southern Denmark
Frequently Asked Questions
Who can join the NCT07454993 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07454993 currently recruiting?
Yes, NCT07454993 is actively recruiting participants. Contact the research team at magnus.ploug@rsyd.dk for enrollment information.
Where is the NCT07454993 trial being conducted?
This trial is being conducted at Esbjerg, Denmark.
Who is sponsoring the NCT07454993 clinical trial?
NCT07454993 is sponsored by Esbjerg Hospital - University Hospital of Southern Denmark. The principal investigator is Magnus Ploug, MD, PhD at Institute of Regional Health Research, University of Southern Denmark. The trial plans to enroll 1,042 participants.