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OpenTrials
Completed

NCT Number: NCT04258800

Impact of Music in Colonoscopy

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.

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Key information

Conditions

Colonoscopy Behavior Music Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Personal Satisfaction Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Ulm

Ulm, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music during colonoscopy

Device

Music during colonoscopy

Primary outcomes

  1. Impact of Music on EMG (M. Zygomaticus, M. Corrugator)

    Time frame: During colonoscopy procedure

    Evaluation of biopotential signals for the objective operationalization of stress reduction

  2. Impact of Music on EKG (heart rate, heart rate variability)

    Time frame: During colonoscopy procedure

    Evaluation of biopotential signals for the objective operationalization of stress reduction

  3. Impact of Music on skin conductance in micro Siemens

    Time frame: During colonoscopy procedure

    Evaluation of biopotential signals for the objective operationalization of stress reduction

  4. Impact of Music on skin temperature in degrees Celsius

    Time frame: During colonoscopy procedure

    Evaluation of biopotential signals for the objective operationalization of stress reduction

  5. Impact of Music on Propofol Dosis in millilitres

    Time frame: During colonoscopy procedure

    Evaluation of sedation requirements for the objective operationalization of stress reduction

  6. Impact of Music on procedure time in minutes

    Time frame: During colonoscopy procedure

    Evaluation of examination time for the objective operationalization of stress reduction

  7. Patient satisfaction with endoscopical procedure by means of questionnaire

    Time frame: Approximately 45 minutes after colonoscopy was finished

    Satisfaction of the patient with endoscopical procedure rated on a scale from 1 to 4 (1 means best rating, 7 means worst rating)

  8. Patient satisfaction with sedation by means of questionnaire

    Time frame: Approximately 45 minutes after colonoscopy was finished

    Satisfaction of the patient with sedation rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)

  9. Endoscopist satisfaction by means of questionnaire

    Time frame: immediately after colonoscopy was finished

    Satisfaction of the endoscopist with endoscopical procedure rated on a scale from 1 to 7 (1 means best rating, 7 means worst rating)

Sponsors and collaborators

Lead sponsor

University of Ulm

Other

Collaborators

  • University Hospital Ulm

Registry information

Official study title

Impact of Music During Colonoscopy on Sympathetic - Autonomic Nervous System

Acronym: ColoRelaxTone

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2020
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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