PainNCT07454993
The Effect of Music During Colonoscopy
A study testing Music intervention in people with Pain and Pain Management, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pain Management
- What is being tested?
- Music intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,042 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Mar 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Scheduled for ambulatory (outpatient) colonoscopy
- Able to provide written informed consent
- Able to understand and read Danish
Who cannot join
- Planned colonoscopy under propofol sedation or general anesthesia
- Planned endoscopic mucosal resection (EMR)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Esbjerg Hospital, University Hospital of Southern Denmark
Esbjerg, Region Syd, 6700
About this study
Official title: The Effect of Music During Colonoscopy: A Randomized Controlled Trial on Pain
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.
Read more
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.
Read the 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.
- Conditions
- Pain, Pain Management
- Being tested
- Music intervention
- Keywords
- pain, colonoscopy, music, procedural pain, pain management, colorectal cancer screening
- Medical subject headings
- Pain, Agnosia, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Music during colonoscopy | Experimental | Playback of pre-selected pop and rock music via speaker in the procedure room throughout colonoscopy. Receives: Other: Music intervention |
| Standard Colonoscopy (No Music) | No intervention | Participants undergo colonoscopy according to standard practice without music played during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Yes/no answer to questionaire item
Measured: 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?
Yes/no answer to questionaire item
Measured: Immediately after the procedure, before discharge from the endoscopy unit (minimum 15 minutes after procedure completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start12 Mar 2026
- Primary completion15 Sep 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,042 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Ploug, MD, PhD, Principal investigator, Institute of Regional Health Research, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454993
- Sponsor's protocol ID
- 25/60167
- Status last verified
- Oct 2026
- First submitted
- 23 Feb 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music During Colonoscopy: A Randomized Controlled Trial on Pain
- ClinicalTrials.gov ID
- NCT07454993
- Acronym / sponsor ID
- 25/60167
- Conditions
- Pain, Pain Management
- Keywords
- pain, colonoscopy, music, procedural pain, pain management, colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,042 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Study start
- 12 Mar 2026 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music during colonoscopy | Experimental | Other: Music interventionPlayback of pre-selected pop and rock music via speaker in the procedure room throughout colonoscopy. |
| Standard Colonoscopy (No Music) | No intervention | –Participants undergo colonoscopy according to standard practice without music played during the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Scheduled for ambulatory (outpatient) colonoscopy
- Able to provide written informed consent
- Able to understand and read Danish
Key exclusion criteria (2 listed)
- Planned colonoscopy under propofol sedation or general anesthesia
- Planned endoscopic mucosal resection (EMR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music interventionPlayback 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. | Other | Music during colonoscopy |
Primary outcome
Patient-Reported Pain During Colonoscopy
Time frame: Immediately after the procedure, before discharge from the endoscopy unit (minimum 15 minutes after procedure completion)
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.
2 secondary outcomes
Were the patients aware that music was being played during the colonoscopy
Time frame: 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?
Time frame: Immediately after the procedure, before discharge from the endoscopy unit (minimum 15 minutes after procedure completion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magnus Ploug, MD, PhD principal investigator
Institute of Regional Health Research, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music intervention in people with Pain and Pain Management, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Pain During Colonoscopy (time frame: Immediately after the procedure, before discharge from the endoscopy unit (minimum 15 minutes after procedure completion)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.