Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 8:10 PM
Study NCT ID:
NCT07454993
Status:
RECRUITING
Last Update Posted:
2026-03-16
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Music During Colonoscopy
Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Organization:
Study Overview
Official Title:
The Effect of Music During Colonoscopy: A Randomized Controlled Trial on Pain
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
Detailed Description
Colonoscopy is a cornerstone in the diagnosis and surveillance of colorectal diseases, including inflammatory bowel disease and colorectal cancer. Despite its clinical importance and widespread use, colonoscopy is frequently associated with discomfort, pain, and anxiety. Even with standard analgesia and sedation practices, a substantial proportion of patients report moderate to severe procedural pain. Fear of pain and discomfort is also recognized as a barrier to participation in colorectal cancer screening programs.
Music has been investigated as a non-pharmacological intervention in multiple clinical settings. Proposed mechanisms include distraction, modulation of emotional processing, reduction of anxiety, and activation of descending inhibitory pain pathways. Music interventions have demonstrated beneficial effects on anxiety and perceived pain in perioperative and procedural contexts. However, previous studies examining music during colonoscopy have produced inconsistent results. Many have been limited by small sample sizes, heterogeneous methodologies, and variations in sedation practices and outcome assessment. A sufficiently powered randomized trial is therefore warranted to clarify whether music has a clinically meaningful analgesic effect during colonoscopy.
This trial is designed to evaluate the effect of music played during colonoscopy on patient-reported pain. The intervention consists of background playback of preselected popular pop and rock music during the entire colonoscopy procedure. The music is delivered via a speaker in the procedure room at a volume that allows normal communication between patient and staff. The music can be adjusted or discontinued at any time upon request. The control condition reflects standard practice without music.
The colonoscopy procedure itself, including preparation, monitoring, sedation, analgesia, and post-procedure care, follows standard departmental protocols and is not altered by participation in the study. Clinical management decisions, including medication dosing, are made by the treating healthcare professionals according to routine practice and are not protocol-driven.
Pain intensity is assessed using a numeric rating scale (0-10), a widely validated and clinically applicable measure of acute procedural pain. Pain data are collected both during and immediately after the procedure to capture both staff-assessed and patient-reported perspectives. Additional procedural variables, including use of sedatives and analgesics, are recorded to allow interpretation of outcomes in the context of routine clinical practice.
The study is conducted at a single center in a real-world endoscopy unit setting to enhance external validity. The pragmatic design aims to determine whether music, as a simple and low-cost environmental modification, can meaningfully improve patient comfort without interfering with workflow or patient safety.
Because the intervention is non-invasive and does not alter medical treatment, the associated risk is considered minimal. Should the intervention demonstrate a reduction in patient-reported pain, it may support implementation of music as a scalable, low-cost strategy to improve the patient experience during colonoscopy.
Colonoscopy is a cornerstone in the diagnosis and surveillance of colorectal diseases, including inflammatory bowel disease and colorectal cancer. Despite its clinical importance and widespread use, colonoscopy is frequently associated with discomfort, pain, and anxiety. Even with standard analgesia and sedation practices, a substantial proportion of patients report moderate to severe procedural pain. Fear of pain and discomfort is also recognized as a barrier to participation in colorectal cancer screening programs.
Music has been investigated as a non-pharmacological intervention in multiple clinical settings. Proposed mechanisms include distraction, modulation of emotional processing, reduction of anxiety, and activation of descending inhibitory pain pathways. Music interventions have demonstrated beneficial effects on anxiety and perceived pain in perioperative and procedural contexts. However, previous studies examining music during colonoscopy have produced inconsistent results. Many have been limited by small sample sizes, heterogeneous methodologies, and variations in sedation practices and outcome assessment. A sufficiently powered randomized trial is therefore warranted to clarify whether music has a clinically meaningful analgesic effect during colonoscopy.
This trial is designed to evaluate the effect of music played during colonoscopy on patient-reported pain. The intervention consists of background playback of preselected popular pop and rock music during the entire colonoscopy procedure. The music is delivered via a speaker in the procedure room at a volume that allows normal communication between patient and staff. The music can be adjusted or discontinued at any time upon request. The control condition reflects standard practice without music.
The colonoscopy procedure itself, including preparation, monitoring, sedation, analgesia, and post-procedure care, follows standard departmental protocols and is not altered by participation in the study. Clinical management decisions, including medication dosing, are made by the treating healthcare professionals according to routine practice and are not protocol-driven.
Pain intensity is assessed using a numeric rating scale (0-10), a widely validated and clinically applicable measure of acute procedural pain. Pain data are collected both during and immediately after the procedure to capture both staff-assessed and patient-reported perspectives. Additional procedural variables, including use of sedatives and analgesics, are recorded to allow interpretation of outcomes in the context of routine clinical practice.
The study is conducted at a single center in a real-world endoscopy unit setting to enhance external validity. The pragmatic design aims to determine whether music, as a simple and low-cost environmental modification, can meaningfully improve patient comfort without interfering with workflow or patient safety.
Because the intervention is non-invasive and does not alter medical treatment, the associated risk is considered minimal. Should the intervention demonstrate a reduction in patient-reported pain, it may support implementation of music as a scalable, low-cost strategy to improve the patient experience during colonoscopy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: