The Effect of Music on Colonoscopy (MUSICOL) (MUSICOL)

• ClinicalTrials.gov Identifier: NCT04628052
• Recruitment Status: Recruiting
• First Posted: November 13, 2020
• Last Update Posted: July 13, 2021
• Sponsor: University of Illinois at Chicago
• Information provided by (Responsible Party): Asim Shuja, University of Illinois at Chicago

Study Description

Brief 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 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.

Condition or disease	Intervention/treatment	Phase
Procedural Anxiety; Colon Polyp	Procedure: Colonoscopy	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: The Effect of Music on Colonoscopy (MUSICOL): A Randomized Controlled Trial
• Actual Study Start Date: November 20, 2020
• Estimated Primary Completion Date: July 2022
• Estimated Study Completion Date: August 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Music	Procedure: Colonoscopy; Music vs. No-Music
No Intervention: No-Music

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Dose of Sedative required [ Time Frame: Up to 3 hours ]
3. 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.
4. 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'.

Secondary Outcome Measures :

1. Total procedure time [ Time Frame: Upto 2 hours ]
   Total time for completion of the procedure, starting from insertion of the scope till the scope is out from the colon.
2. Time to reach cecum [ Time Frame: Upto 1 hour ]
   Time taken from insertion of the colonoscope in rectum till it reaches the cecum
3. Withdrawal time [ Time Frame: Upto 1 hour ]
   Time taken from the start of inspection of cecum till the withdrawal of the scope from rectum
4. Adenoma detection rate [ Time Frame: Upto 2 hours ]
   Number of screening colonoscopies in which one or more adenomas are detected, divided by the total number of screening colonoscopies.
5. Adenomas per colonoscopy [ Time Frame: Upto 2 hours ]
   Number of detected adenomas divided by the total number of screening colonoscopies.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• 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.

Contacts and Locations

Contacts

Contact: Asim Shuja, MD; 312-355-9984; ashuja@uic.edu

Locations

United States, Illinois

University of Illinois at Chicago; Recruiting

Chicago, Illinois, United States, 60612

Contact: Asim Shuja

Sponsors and Collaborators

University of Illinois at Chicago

Investigators

• Principal Investigator: Asim Shuja, MD; University of Illinois at Chicago

More Information

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.

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. Review.

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.

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.

Bashiri M, Akçalı D, Coşkun D, Cindoruk M, Dikmen A, Çifdalöz 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.

• Responsible Party: Asim Shuja, Assistant Professor of Medicine, University of Illinois at Chicago
• ClinicalTrials.gov Identifier: NCT04628052
• Other Study ID Numbers: 2020-0548
• First Posted: November 13, 2020
• Last Update Posted: July 13, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Colonic Polyps; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical