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Impact of Music in Colonoscopy

Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04258800
Acronym
ColoRelaxTone
Enrollment
300
Registered
2020-02-06
Start date
2019-11-12
Completion date
2020-03-26
Last updated
2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonoscopy, Music, Pain

Keywords

colonoscopy, music, relaxation, satisfaction

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.

Interventions

DEVICEMusic during colonoscopy

Music during colonoscopy

Sponsors

University Hospital Ulm
CollaboratorOTHER
University of Ulm
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Impact of Music on EMG (M. Zygomaticus, M. Corrugator)During colonoscopy procedureEvaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on EKG (heart rate, heart rate variability)During colonoscopy procedureEvaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on skin conductance in micro SiemensDuring colonoscopy procedureEvaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on skin temperature in degrees CelsiusDuring colonoscopy procedureEvaluation of biopotential signals for the objective operationalization of stress reduction
Impact of Music on Propofol Dosis in millilitresDuring colonoscopy procedureEvaluation of sedation requirements for the objective operationalization of stress reduction
Impact of Music on procedure time in minutesDuring colonoscopy procedureEvaluation of examination time for the objective operationalization of stress reduction
Patient satisfaction with endoscopical procedure by means of questionnaireApproximately 45 minutes after colonoscopy was finishedSatisfaction 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 questionnaireApproximately 45 minutes after colonoscopy was finishedSatisfaction of the patient with sedation rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)
Endoscopist satisfaction by means of questionnaireimmediately after colonoscopy was finishedSatisfaction of the endoscopist with endoscopical procedure rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026