The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure

NCT ID: NCT04641052

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-24

Study Completion Date

2021-02-11

Brief Summary

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This study aims to investigate the effect of music listening on patients who will have Endoscopic Retrograde Cholangio-Pancreatography Procedure on vital signs, anxiety, and pain. This will be a randomized controlled experimental study.

The study will be conducted with two groups: the intervention group (n=35) and the control group (n=35). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to music by the researchers for 15 minutes before the procedure.

Detailed Description

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Conditions

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Endoscopic Retrograde Cholangio-Pancreatography Anxiety Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music Intervention Group

The music intervention group will be listened to the music by the researchers for the duration of 15 minutes before the procedure as well as the standard care.

Group Type EXPERIMENTAL

Music listening

Intervention Type OTHER

The music type will be chosen by the patients and researchers will not have any influence on their choices.

No Intervention Group

The control group patients will receive standard care only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music listening

The music type will be chosen by the patients and researchers will not have any influence on their choices.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patients aged 18 or above,
* with a scheduled ERCP procedure
* with the ASA grade level of I-II clinically
* without a hearing/speech impairment
* willing to participate in the research
* without a mental problem or diagnosis of psychiatric disorder
* without any a diagnosis of depression

Exclusion Criteria

* Patients with an emergency ERCP procedure
* with a hearing/speech impairment
* not willing to participate in the research
* with a mental problem or diagnosis of psychiatric disorder
* with a diagnosis of depression
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Afyonkarahisar Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Yeliz Ciğerci

Assistant Proffesor PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yeliz CIGERCI, Phd

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

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Afyonkarahisar Health Sciences university Hospital

Afyonkarahisar, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2020\481

Identifier Type: -

Identifier Source: org_study_id

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