Impact of Music in Colonoscopy

Pain Clinical Trial

— ColoRelaxTone  

Official title:

Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04258800
• Other study ID #: MUSIC123
• Status: Completed
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: March 26, 2020

Study information

• Verified date: March 2020
• Source: University of Ulm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 26, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy
• Music
• Pain

Intervention

Device:
• Music during colonoscopy
Music during colonoscopy

Locations

Country	Name	City	State
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	University Hospital Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of Music on EMG (M. Zygomaticus, M. Corrugator)	Evaluation of biopotential signals for the objective operationalization of stress reduction	During colonoscopy procedure
Primary	Impact of Music on EKG (heart rate, heart rate variability)	Evaluation of biopotential signals for the objective operationalization of stress reduction	During colonoscopy procedure
Primary	Impact of Music on skin conductance in micro Siemens	Evaluation of biopotential signals for the objective operationalization of stress reduction	During colonoscopy procedure
Primary	Impact of Music on skin temperature in degrees Celsius	Evaluation of biopotential signals for the objective operationalization of stress reduction	During colonoscopy procedure
Primary	Impact of Music on Propofol Dosis in millilitres	Evaluation of sedation requirements for the objective operationalization of stress reduction	During colonoscopy procedure
Primary	Impact of Music on procedure time in minutes	Evaluation of examination time for the objective operationalization of stress reduction	During colonoscopy procedure
Primary	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)	Approximately 45 minutes after colonoscopy was finished
Primary	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)	Approximately 45 minutes after colonoscopy was finished
Primary	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)	immediately after colonoscopy was finished