Clinical trial NCT04258800: Impact of Music in Colonoscopy
Official title: Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Music
Pain
Keywords: colonoscopy
music
relaxation
satisfaction
Lead sponsor: University of Ulm
Sponsor class: OTHER
Collaborators: name: University Hospital Ulm
First posted: 2020-02-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of Music on EMG (M. Zygomaticus, M. Corrugator)
timeFrame: During colonoscopy procedure
measure: Impact of Music on EKG (heart rate, heart rate variability)
timeFrame: During colonoscopy procedure
measure: Impact of Music on skin conductance in micro Siemens
timeFrame: During colonoscopy procedure
measure: Impact of Music on skin temperature in degrees Celsius
timeFrame: During colonoscopy procedure
measure: Impact of Music on Propofol Dosis in millilitres
timeFrame: During colonoscopy procedure
measure: Impact of Music on procedure time in minutes
timeFrame: During colonoscopy procedure
measure: Patient satisfaction with endoscopical procedure by means of questionnaire
timeFrame: Approximately 45 minutes after colonoscopy was finished
measure: Patient satisfaction with sedation by means of questionnaire
timeFrame: Approximately 45 minutes after colonoscopy was finished
measure: Endoscopist satisfaction by means of questionnaire
timeFrame: immediately after colonoscopy was finished
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: University Hospital Ulm
name: Benjamin Walter, MD
role: PRINCIPAL_INVESTIGATOR
References: