Impact of Music in Colonoscopy

NCT ID: NCT04258800

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-12
• Study Completion Date: 2020-03-26

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.

Conditions

Colonoscopy; Music; Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

With music

Colonoscopy performed with music

Group Type: EXPERIMENTAL

Music during colonoscopy

Intervention Type: DEVICE

Music during colonoscopy

Without music

Colonoscopy performed without music

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Music during colonoscopy

Music during colonoscopy

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ulm

OTHER

Sponsor Role: collaborator

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Thomas Seufferlein

Professor, Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Walter, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ulm

Locations

Universitätsklinikum Ulm

Ulm, , Germany

Countries

Germany

Other Identifiers

MUSIC123

Identifier Type: -

Identifier Source: org_study_id