Procedural AnxietyMUSICOLNCT04628052
The Effect of Music on Colonoscopy (MUSICOL)
A study testing Colonoscopy in people with Procedural Anxiety and Colon Polyp, run by University of Illinois Chicago at 1 site in United States.
Trial summary
Colonoscopy is an essential tool for diagnostic evaluation for a wide range of gastrointestinal complaints and is considered the gold standard for colorectal cancer screening. This procedure is often associated with patient anxiety both prior to and during the procedure, as well as discomfort,which is managed with… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Procedural Anxiety, Colon Polyp
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 3 Mar 2023
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80
- Outpatient
- Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
- Procedure is to be performed solely by an attending gastroenterologist
- Sedation plan is moderate sedation (midazolam, fentanyl, and/or diphenhydramine administered by RN)
Who cannot join
- Age < 18 and > 80
- Inpatients
- Deafness or hearing loss requiring use of hearing aids
- Patient is prescribed and taking opiate pain medications or benzodiazepine anxiety medications
- Previous history of colon cancer
- Previous history of colon resection
Show all 13Show fewer
- History of incomplete or aborted colonoscopy procedures
- Participation of an anesthesia professional for administration of monitored anesthesia care of general anesthesia
- ASA PS Classification > 4
- Double procedures (EGD \& Colonoscopy)
- A gastroenterology fellow will be participating in the procedure
- Endoscopist cancels the colonoscopy before scope insertion (most commonly due to believing the prep is inadequate or a contraindication identified)
- Minors, and non-English speaking subjects will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: The Effect of Music on Colonoscopy (MUSICOL): A Randomized Controlled Trial
Colonoscopy is an essential tool for diagnostic evaluation for a wide range of gastrointestinal complaints and is considered the gold standard for colorectal cancer screening. This procedure is often associated with patient anxiety both prior to and during the procedure, as well as discomfort,which is managed with procedural sedation.Anticipation of an uncomfortable experience can deter patients from undergoing the procedure despite it being medically indicated. Music has a number of beneficial effects including improving senses of relaxation and well being. Use of music during colonoscopy is inconsistent and there are no society guidelines or recommendations regarding its use. The investigators hypothesize that music will improve the overall patient experience and enhance endoscopist performance.The investigators propose a randomized controlled trial to study effects of music on both the patient experience and endoscopist performance during colonoscopy. Eligible patients will be randomized to two groups: a "music group" and a "no music"control group.Patients in the music group will be asked for their preference of music to be played during their colonoscopy. For patients in the music group, this music will be played in the procedure room during the procedure, while those in the control group will have no music playing. Patient anxiety and pain will be assessed both before and after the procedure.Overall patient experience after the procedure will be assessed on a likert scale. The performance of the endoscopist will be assessed by measuring adenoma detection rate and adenomas per colonoscopy. Additional outcomes to be assessed include total procedure time and amount of sedation required.
Read the detailed description
Background/Scientific Rationale:
Colorectal cancer is the third most common diagnosed cancer in the United States and is second only to lung cancer in number of deaths. Widespread adoption of colorectal cancer screening has resulted in earlier detection as well as reduction in mortality. Colonoscopy, compared to other methods of screening has additional benefit in its ability to prevent the development of colon cancer through removal of precancerous polyps.Besides it being considered the gold standard for colorectal cancer screening, colonoscopy is an essential tool for diagnostic evaluation for a wide range of gastrointestinal complaints.Despite the proven success of colorectal cancer screening programs and public understanding of its importance, there remains a gap in adherence. In a recent study, about 64% of eligible patients received CRC screening within the past 10 years, which is far behind the "80% by 2018"target. Besides colonoscopy, alternative tools have been developed in an effort to improve adherence to screening including fecal immunochemical testing and fecal DNA testing. However, these tests still have low sensitivity for advanced adenomas of 24% and 42%, respectively, and lack the added benefit of colonoscopy for prevention of development of colon cancer.Patients often experience feelings of anxiety and anticipated discomfort both prior to and during the procedure; one study reported greater than 50% of patients have moderate to severe anxiety about undergoing the procedure. These concerns regarding an anticipated unpleasant experience deter some patients for whom the procedure is indicated from undergoing this valuable test.Sedation is administered during the procedure to alleviate patient discomfort, but this is associated with potential adverse effects, especially if increasing doses are required in response to increased discomfort or anxiety.Sources of patient anxiety about colonoscopy include the necessary bowel preparation,fear of embarrassment, pain, potential complications, sedation, and the potential of a diagnosis of cancer.This anxiety can increase pain perception in patients: a key predictor of pain during colonoscopy is a patient's pre-procedural anxiety level.This anxiety and pain can manifest in the need for increased sedation, increased length of procedure, and reduced patient satisfaction.One way to improve the patient experience that has been investigated is reduced volume bowel preparations. But, prior studies have also suggested that music during a colonoscopy can significantly improve patient satisfaction, reduce anxiety and pain, and reduce the total sedation medication requirement
The performance of gastroenterologists is measured by quality factors such as adenoma detection rate and adenomas per colonoscopy. A number of techniques have been studied to improve these parameters, including use of colonoscope caps and second looks on the right side of the colon and right-sided retroflexion. Additionally, prior studies have suggested improvement from music being played in the endoscopy suite. An intervention that is inexpensive and without adverse effects that can potentially improve the patient experience and as a consequence hypothetically adherence to screening programs, and improve endoscopist performance, would be expected to be widely adopted. Yet, use of music during colonoscopy is inconsistent and there are no society guidelines or recommendations regarding its use. Potential reasons for this include a sense of a lack of adequate body of evidence and inconsistency in the method of administration.The investigators aim to provide more convincing data to support or refute the benefit of music during colonoscopy to aid the decision on whether routinely offering music during the procedure should be considered a standard of care.
Objectives/Aims:
The investigators' aim is to assess whether playing music during a colonoscopy procedure improves the patient experience and willingness to undergo the procedure again(measured on a Likert scale), improves endoscopist performance (as measured by adenoma detection rate and time to reach cecum), and reduces the mean dose of sedatives required during the procedure (both midazolam and fentanyl).Secondary endpoints include reduction in pain,total procedure time, and withdrawal time.The delay between the time the procedure was scheduled for and the time the procedure actually commenced will also be measured, as long delays are a not uncommon occurrence that can separately negatively impact the patient experience and therefore this variable maybe used for post-hoc analysis. The investigators anticipate the study to take place over the course of 1 year.
- Conditions
- Procedural Anxiety, Colon Polyp
- Being tested
- Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Music vs. No-Music
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Not described Receives: Procedure: Colonoscopy |
| No-Music | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Score
Will be using PROMIS anxiety short forms. Patients will be asked if in the past 7 days, they felt anxious or fearful or worried or unable to focus or nervous or uneasy or tense. They will have to choose one option like Never or Rarely or Sometimes or Often or Always.
Measured: Up to 1 hour
Dose of Sedative required
Measured: Up to 3 hours
Level of Pain
Pain will be measured using a 'Likert Scale' on a scale from 0 to 10, 0 being no pain and 10 being the worse possible pain.
Measured: Change from baseline pain level at 2 hours
Willingness to undergo procedure in future
Patient willingness to undergo procedure in future will be measure using a '5-point Likert scale' on a scale from 1 to 5, 1 means 'I would never do this procedure again' while 5 means 'I would do it again without any hesitation'.
Measured: Upto 3 hours
Secondary outcomes (5)
Total procedure time
Total time for completion of the procedure, starting from insertion of the scope till the scope is out from the colon.
Measured: Upto 2 hours
Time to reach cecum
Time taken from insertion of the colonoscope in rectum till it reaches the cecum
Measured: Upto 1 hour
Withdrawal time
Time taken from the start of inspection of cecum till the withdrawal of the scope from rectum
Measured: Upto 1 hour
Adenoma detection rate
Number of screening colonoscopies in which one or more adenomas are detected, divided by the total number of screening colonoscopies.
Measured: Upto 2 hours
Adenomas per colonoscopy
Number of detected adenomas divided by the total number of screening colonoscopies.
Measured: Upto 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start20 Nov 2020
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Why it stopped: Administratively Closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Procedural AnxietyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asim Shuja, University of Illinois Chicago
- Investigators
- Asim Shuja, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628052
- Sponsor's protocol ID
- 2020-0548
- Acronym
- MUSICOL
- Status last verified
- Feb 2024
- First submitted
- 19 Jun 2020
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berkowitz Z, Zhang X, Richards TB, Nadel M, Peipins LA, Holt J. Multilevel Small-Area Estimation of Colorectal Cancer Screening in the United States. Cancer Epidemiol Biomarkers Prev. 2018 Mar;27(3):245-253. doi: 10.1158/1055-9965.EPI-17-0488.
PubMed 29500250Song LL, Li YM. Current noninvasive tests for colorectal cancer screening: An overview of colorectal cancer screening tests. World J Gastrointest Oncol. 2016 Nov 15;8(11):793-800. doi: 10.4251/wjgo.v8.i11.793.
PubMed 27895817Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.
PubMed 30385831Hsueh FC, Chen CM, Sun CA, Chou YC, Hsiao SM, Yang T. A Study on the Effects of a Health Education Intervention on Anxiety and Pain During Colonoscopy Procedures. J Nurs Res. 2016 Jun;24(2):181-9. doi: 10.1097/jnr.0000000000000112.
PubMed 26551213Bashiri M, Akcali D, Coskun D, Cindoruk M, Dikmen A, Cifdaloz BU. Evaluation of pain and patient satisfaction by music therapy in patients with endoscopy/colonoscopy. Turk J Gastroenterol. 2018 Sep;29(5):574-579. doi: 10.5152/tjg.2018.18200.
PubMed 30260780
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Colonoscopy (MUSICOL): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04628052
- Acronym / sponsor ID
- MUSICOL / 2020-0548
- Conditions
- Procedural Anxiety, Colon Polyp
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively Closed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 13 Nov 2020 (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 essential tool for diagnostic evaluation for a wide range of gastrointestinal complaints and is considered the gold standard for colorectal cancer screening. This procedure is often associated with patient anxiety both prior to and during the procedure, as well as discomfort,which is managed with procedural sedation.Anticipation of an uncomfortable experience can deter patients from undergoing the procedure despite it being medically indicated. Music has a number of beneficial effects including improving senses of relaxation and well being. Use of music during colonoscopy is inconsistent and there are no society guidelines or recommendations regarding its use. The investigators hypothesize that music will improve the overall patient experience and enhance endoscopist performance.The investigators propose a randomized controlled trial to study effects of music on both the patient experience and endoscopist performance during colonoscopy. Eligible patients will be randomized to two groups: a "music group" and a "no music"control group.Patients in the music group will be asked for their preference of music to be played during their colonoscopy. For patients in the music group, this music will be played in the procedure room during the procedure, while those in the control group will have no music playing. Patient anxiety and pain will be assessed both before and after the procedure.Overall patient experience after the procedure will be assessed on a likert scale. The performance of the endoscopist will be assessed by measuring adenoma detection rate and adenomas per colonoscopy. Additional outcomes to be assessed include total procedure time and amount of sedation required.
Detailed description
Background/Scientific Rationale:
Colorectal cancer is the third most common diagnosed cancer in the United States and is second only to lung cancer in number of deaths. Widespread adoption of colorectal cancer screening has resulted in earlier detection as well as reduction in mortality. Colonoscopy, compared to other methods of screening has additional benefit in its ability to prevent the development of colon cancer through removal of precancerous polyps.Besides it being considered the gold standard for colorectal cancer screening, colonoscopy is an essential tool for diagnostic evaluation for a wide range of gastrointestinal complaints.Despite the proven success of colorectal cancer screening programs and public understanding of its importance, there remains a gap in adherence. In a recent study, about 64% of eligible patients received CRC screening within the past 10 years, which is far behind the "80% by 2018"target. Besides colonoscopy, alternative tools have been developed in an effort to improve adherence to screening including fecal immunochemical testing and fecal DNA testing. However, these tests still have low sensitivity for advanced adenomas of 24% and 42%, respectively, and lack the added benefit of colonoscopy for prevention of development of colon cancer.Patients often experience feelings of anxiety and anticipated discomfort both prior to and during the procedure; one study reported greater than 50% of patients have moderate to severe anxiety about undergoing the procedure. These concerns regarding an anticipated unpleasant experience deter some patients for whom the procedure is indicated from undergoing this valuable test.Sedation is administered during the procedure to alleviate patient discomfort, but this is associated with potential adverse effects, especially if increasing doses are required in response to increased discomfort or anxiety.Sources of patient anxiety about colonoscopy include the necessary bowel preparation,fear of embarrassment, pain, potential complications, sedation, and the potential of a diagnosis of cancer.This anxiety can increase pain perception in patients: a key predictor of pain during colonoscopy is a patient's pre-procedural anxiety level.This anxiety and pain can manifest in the need for increased sedation, increased length of procedure, and reduced patient satisfaction.One way to improve the patient experience that has been investigated is reduced volume bowel preparations. But, prior studies have also suggested that music during a colonoscopy can significantly improve patient satisfaction, reduce anxiety and pain, and reduce the total sedation medication requirement
The performance of gastroenterologists is measured by quality factors such as adenoma detection rate and adenomas per colonoscopy. A number of techniques have been studied to improve these parameters, including use of colonoscope caps and second looks on the right side of the colon and right-sided retroflexion. Additionally, prior studies have suggested improvement from music being played in the endoscopy suite. An intervention that is inexpensive and without adverse effects that can potentially improve the patient experience and as a consequence hypothetically adherence to screening programs, and improve endoscopist performance, would be expected to be widely adopted. Yet, use of music during colonoscopy is inconsistent and there are no society guidelines or recommendations regarding its use. Potential reasons for this include a sense of a lack of adequate body of evidence and inconsistency in the method of administration.The investigators aim to provide more convincing data to support or refute the benefit of music during colonoscopy to aid the decision on whether routinely offering music during the procedure should be considered a standard of care.
Objectives/Aims:
The investigators' aim is to assess whether playing music during a colonoscopy procedure improves the patient experience and willingness to undergo the procedure again(measured on a Likert scale), improves endoscopist performance (as measured by adenoma detection rate and time to reach cecum), and reduces the mean dose of sedatives required during the procedure (both midazolam and fentanyl).Secondary endpoints include reduction in pain,total procedure time, and withdrawal time.The delay between the time the procedure was scheduled for and the time the procedure actually commenced will also be measured, as long delays are a not uncommon occurrence that can separately negatively impact the patient experience and therefore this variable maybe used for post-hoc analysis. The investigators anticipate the study to take place over the course of 1 year.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Procedure: Colonoscopy |
| No-Music | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80
- Outpatient
- Undergoing colonoscopy for screening, surveillance, or diagnostic purposes
- Procedure is to be performed solely by an attending gastroenterologist
- Sedation plan is moderate sedation (midazolam, fentanyl, and/or diphenhydramine administered by RN)
Key exclusion criteria (13 listed)
- Age < 18 and > 80
- Inpatients
- Deafness or hearing loss requiring use of hearing aids
- Patient is prescribed and taking opiate pain medications or benzodiazepine anxiety medications
- Previous history of colon cancer
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 |
|---|---|---|
| ColonoscopyMusic vs. No-Music | Procedure or surgery | Music |
Primary outcome
Anxiety Score
Time frame: Up to 1 hour
Will be using PROMIS anxiety short forms. Patients will be asked if in the past 7 days, they felt anxious or fearful or worried or unable to focus or nervous or uneasy or tense. They will have to choose one option like Never or Rarely or Sometimes or Often or Always.
Dose of Sedative required
Time frame: Up to 3 hours
Level of Pain
Time frame: Change from baseline pain level at 2 hours
Pain will be measured using a 'Likert Scale' on a scale from 0 to 10, 0 being no pain and 10 being the worse possible pain.
Willingness to undergo procedure in future
Time frame: Upto 3 hours
Patient willingness to undergo procedure in future will be measure using a '5-point Likert scale' on a scale from 1 to 5, 1 means 'I would never do this procedure again' while 5 means 'I would do it again without any hesitation'.
5 secondary outcomes
Total procedure time
Time frame: Upto 2 hours
Time to reach cecum
Time frame: Upto 1 hour
Withdrawal time
Time frame: Upto 1 hour
Adenoma detection rate
Time frame: Upto 2 hours
Adenomas per colonoscopy
Time frame: Upto 2 hours
Results and safety
The study was stopped early (reason given: Administratively Closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 29500250Berkowitz Z, Zhang X, Richards TB, Nadel M, Peipins LA, Holt J. Multilevel Small-Area Estimation of Colorectal Cancer Screening in the United States. Cancer Epidemiol Biomarkers Prev. 2018 Mar;27(3):245-253. doi: 10.1158/1055-9965.EPI-17-0488.
- Background: PubMed 27895817Song LL, Li YM. Current noninvasive tests for colorectal cancer screening: An overview of colorectal cancer screening tests. World J Gastrointest Oncol. 2016 Nov 15;8(11):793-800. doi: 10.4251/wjgo.v8.i11.793.
- Background: PubMed 30385831Yang C, Sriranjan V, Abou-Setta AM, Poluha W, Walker JR, Singh H. Anxiety Associated with Colonoscopy and Flexible Sigmoidoscopy: A Systematic Review. Am J Gastroenterol. 2018 Dec;113(12):1810-1818. doi: 10.1038/s41395-018-0398-8. Epub 2018 Nov 1.
- Background: PubMed 26551213Hsueh FC, Chen CM, Sun CA, Chou YC, Hsiao SM, Yang T. A Study on the Effects of a Health Education Intervention on Anxiety and Pain During Colonoscopy Procedures. J Nurs Res. 2016 Jun;24(2):181-9. doi: 10.1097/jnr.0000000000000112.
- Background: PubMed 30260780Bashiri M, Akcali D, Coskun D, Cindoruk M, Dikmen A, Cifdaloz BU. Evaluation of pain and patient satisfaction by music therapy in patients with endoscopy/colonoscopy. Turk J Gastroenterol. 2018 Sep;29(5):574-579. doi: 10.5152/tjg.2018.18200.
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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.
Asim Shuja, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy in people with Procedural Anxiety and Colon Polyp, run by University of Illinois Chicago at 1 site in United States.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Feb 2024. 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 United States. 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 was stopped early (reason given: Administratively Closed). Results are not available in the source record.
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?
Anxiety Score (time frame: Up to 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04628052, which also lists 5 linked publications.
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 14 Feb 2024.