Impact of Music in Colonoscopy

Not Applicable

Completed

• Conditions: Music; Pain; Colonoscopy
• Interventions: Device: Music during colonoscopy

• Registration Number: NCT04258800
• Lead Sponsor: University of Ulm

Brief Summary

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.

Detailed Description

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:

* in the face area (corrugator, zygomaticus)

* on the hand (skin conductance, temperature)

* on the torso (electrocardiogram) The satisfaction of the patient and endoscopist with endoscopical procedure were asked using questionnaires.

Study Timeline

• Study Start: 2019-11-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Status Verified: 2020-03
• Primary Completion: 2020-03-15
• Study Completion: 2020-03-26
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Indication for colonoscopy
• conscious sedation with propofol
• ASA state 1 or 2

Exclusion Criteria

• lack of written informed consent
• pregnancy
• General anaesthetics
• ASA state >2
• deafness, Hearing impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With music	Music during colonoscopy	Colonoscopy performed with music

Primary Outcome Measures

Name	Time	Method
Endoscopist satisfaction by means of questionnaire	immediately after colonoscopy was finished	Satisfaction of the endoscopist with endoscopical procedure rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Impact of Music on skin conductance in micro Siemens	During colonoscopy procedure	Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on skin temperature in degrees Celsius	During colonoscopy procedure	Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on Propofol Dosis in millilitres	During colonoscopy procedure	Evaluation of sedation requirements for the objective operationalization of stress reduction
Impact of Music on procedure time in minutes	During colonoscopy procedure	Evaluation of examination time for the objective operationalization of stress reduction
Impact of Music on EMG (M. Zygomaticus, M. Corrugator)	During colonoscopy procedure	Evaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on EKG (heart rate, heart rate variability)	During colonoscopy procedure	Evaluation of biopotential signals for the objective operationalization of stress reduction
Patient satisfaction with endoscopical procedure by means of questionnaire	Approximately 45 minutes after colonoscopy was finished	Satisfaction of the patient with endoscopical procedure rated on a scale from 1 to 4 (1 means best rating, 7 means worst rating)
Patient satisfaction with sedation by means of questionnaire	Approximately 45 minutes after colonoscopy was finished	Satisfaction of the patient with sedation rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)

Trial Locations

Locations (1)

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany