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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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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

Other trials in United States

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.

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 groups in NCT04628052
Study groupRoleWhat they receive
MusicExperimentalNot described
Receives: Procedure: Colonoscopy
No-MusicNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Dose of Sedative required

    Measured: Up to 3 hours

  3. 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

  4. 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)
  1. 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

  2. Time to reach cecum

    Time taken from insertion of the colonoscope in rectum till it reaches the cecum

    Measured: Upto 1 hour

  3. Withdrawal time

    Time taken from the start of inspection of cecum till the withdrawal of the scope from rectum

    Measured: Upto 1 hour

  4. 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

  5. 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.

  1. First posted13 Nov 2020
  2. Study start20 Nov 2020
  3. Primary completion3 Mar 2023
  4. Study completion3 Mar 2023

Why it stopped: Administratively Closed

Resources

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)
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 29500250
  • Song 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 27895817
  • Yang 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 30385831
  • Hsueh 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 26551213
  • Bashiri 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

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.

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