An interventional study of Music during colonoscopy in Colonoscopy, Music and Pain, sponsored by University of Ulm. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-27.
Sponsored by University of Ulm · Not applicable, Interventional, and Supportive care
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.
In the field of endoscopy, stress and pain play a relevant role before and during the examination. A variety of methods have been evaluated to date to provide the patient with relaxation/distraction during the examination. Especially the use of relaxation music. However, the previous studies refer to a subjective assessment of the participants after the examination. Here at least one potential bias is to be assumed from the post-procedural euphoria through the use of propofol and/or midazolam. Pain reactions express themselves explicitly in autonomous function. In contrast to our previous work, the present study uses biopotential signals for the objective operationalization of stress reduction.
The activity of the sympathetic - autonomic nervous system is operationalized by biopotentials fixed to the body surface:
University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Colonoscopy performed with music
Device: Music during colonoscopy
Colonoscopy performed without music
Music during colonoscopy
Impact of Music on EMG (M. Zygomaticus, M. Corrugator)
Evaluation of biopotential signals for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on EKG (heart rate, heart rate variability)
Evaluation of biopotential signals for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on skin conductance in micro Siemens
Evaluation of biopotential signals for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on skin temperature in degrees Celsius
Evaluation of biopotential signals for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on Propofol Dosis in millilitres
Evaluation of sedation requirements for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Impact of Music on procedure time in minutes
Evaluation of examination time for the objective operationalization of stress reduction
Time frame: During colonoscopy procedure
Patient satisfaction with endoscopical procedure by means of questionnaire
Satisfaction of the patient with endoscopical procedure rated on a scale from 1 to 4 (1 means best rating, 7 means worst rating)
Time frame: Approximately 45 minutes after colonoscopy was finished
Patient satisfaction with sedation by means of questionnaire
Satisfaction of the patient with sedation rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Time frame: Approximately 45 minutes after colonoscopy was finished
Endoscopist satisfaction by means of questionnaire
Satisfaction of the endoscopist with endoscopical procedure rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Time frame: immediately after colonoscopy was finished
Plan to share: No
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