Impact of Music in Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System

Conditions
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Colonoscopy, Music, Pain

Intervention / Treatment
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* Device: Music during colonoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: With music<br>Colonoscopy performed with music | Device: Music during colonoscopy<br>* Music during colonoscopy<br>|
| No Intervention: Without music<br>Colonoscopy performed without music | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, music, relaxation, satisfaction