The Effect of Music on Colonoscopy (MUSICOL)

NCT04628052 | Terminated DMC

• 1 other identifier: 2020-0548
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Procedural Anxiety; Colon Polyp

Outcome Measures

Primary Outcomes (4)

• 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.

  Up to 1 hour

• Dose of Sedative required

  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.

  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'.

  Upto 3 hours

Secondary Outcomes (5)

• Total procedure time

  Upto 2 hours

• Time to reach cecum

  Upto 1 hour

• Withdrawal time

  Upto 1 hour

• Adenoma detection rate

  Upto 2 hours

• Adenomas per colonoscopy

  Upto 2 hours

Study Arms (2)

Music

EXPERIMENTAL

Procedure: Colonoscopy

No-Music

NO INTERVENTION

Interventions

Colonoscopy PROCEDURE

Music vs. No-Music

Music

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (5)

• 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.

  PMID: 29500250 BACKGROUND

• 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.

  PMID: 27895817 BACKGROUND

• 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.

  PMID: 30385831 BACKGROUND

• 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.

  PMID: 26551213 BACKGROUND

• 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.

  PMID: 30260780 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Asim Shuja, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: November 13, 2020
• Study Start: November 20, 2020
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: February 14, 2024

Record last verified: 2024-02

Locations

US (1)