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NCT04258800: ColoRelaxTone

Impact of Music in Colonoscopy

Completed NA Last updated 27 March 2020
What this trial tests

NA trial testing Music during colonoscopy in Colonoscopy in 300 participants. Completed in 26 March 2020.

Timeline
12 November 2019
Primary endpoint
15 March 2020
26 March 2020

Quick facts

Lead sponsorUniversity of Ulm
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment300
Start date12 November 2019
Primary completion15 March 2020
Estimated completion26 March 2020
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

University of Ulm

Who can join

18 and older, any sex, with Colonoscopy or Music. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study examines the impact of music during colonoscopy on sympathetic - autonomic nervous system, whose activity is operationalized by biopotentials signals. The music is chosen by the patients themselves. The Null hypothesis: The comparison of the sympathetic - autonomic nervous system (operationalized by biopotentials) intensity between colonoscopy "with" vs. "without" music is not significant. Alternative hypothesis: The comparison of the sympathetic - autonomic nervous system intensity is significantly higher in colonoscopy "without" music vs. "with" music.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Autonomous Nervous Response During Sedation in Colonoscopy and the Relationship With Clinician Satisfaction.
    Hann A, Gruss S, Goetze S, Mehlhase N, et al · · 2021 · PMID 34222272 · DOI 10.3389/fmed.2021.643158

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Other recruiting trials for Colonoscopy

Currently open trials in the same condition.

Other University of Ulm trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04258800.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing