Impact of Music in Colonoscopy (ColoRelaxTone)

Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System

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.

Study Overview

• Status: Completed
• Conditions: Pain; Colonoscopy; Music
• Intervention / Treatment: Device: Music during colonoscopy

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Ulm, Germany
    • Universitatsklinikum Ulm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: With music; Colonoscopy performed with music	Device: Music during colonoscopy; Music during colonoscopy
NO_INTERVENTION: Without music; Colonoscopy performed without music

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Ulm
• Collaborators: University Hospital Ulm
• Investigators: Principal Investigator: Benjamin Walter, MD, University Hospital Ulm

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2019
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 26, 2020

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: satisfaction; music; colonoscopy; relaxation
• Other Study ID Numbers: MUSIC123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No