NCT04258800

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 17, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

December 17, 2019

Last Update Submit

March 26, 2020

Conditions

ColonoscopyMusicPain

Keywords

colonoscopymusicrelaxationsatisfaction

Outcome Measures

Primary Outcomes (9)

  • 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

Study Arms (2)

With music

EXPERIMENTAL

Colonoscopy performed with music

Device: Music during colonoscopy

Without music

NO INTERVENTION

Colonoscopy performed without music

Interventions

Music during colonoscopyDEVICE

Music during colonoscopy

With music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for colonoscopy
  • conscious sedation with propofol
  • ASA state 1 or 2

You may not qualify if:

  • lack of written informed consent
  • pregnancy
  • General anaesthetics
  • ASA state \>2
  • deafness, Hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Benjamin Walter, MD

    University Hospital Ulm

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department

Study Record Dates

First Submitted

December 17, 2019

First Posted

February 6, 2020

Study Start

November 12, 2019

Primary Completion

March 15, 2020

Study Completion

March 26, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)