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NCT04628052: MUSICOL
The Effect of Music on Colonoscopy (MUSICOL)
NA trial testing Colonoscopy in Procedural Anxiety in 83 participants. Terminated before completion.
3 March 2023
Quick facts
| Lead sponsor | University of Illinois at Chicago |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 83 |
| Start date | 20 November 2020 |
| Primary completion | 3 March 2023 |
| Estimated completion | 3 March 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Colonoscopy
Conditions studied
- Procedural Anxiety — all drugs for Procedural Anxiety →
- Colon Polyp — all drugs for Colon Polyp →
Sponsor
University of Illinois at Chicago
Who can join
Adults 18 to 80, any sex, with Procedural Anxiety or Colon Polyp. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04628052
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04628052 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Illinois at Chicago
- Last refreshed: 14 February 2024
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