The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure

Not Applicable

Completed

• Conditions: Anxiety; Pain; Endoscopic Retrograde Cholangio-Pancreatography
• Interventions: Other: Music listening

• Registration Number: NCT04641052
• Lead Sponsor: Afyonkarahisar Health Sciences University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-23
• Study Start: 2020-11-24
• Primary Completion: 2021-02-11
• Study Completion: 2021-02-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-30
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music Intervention Group	Music listening	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.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale for Anxiety (VAS-A)	1 Hour	VAS-A is a 10 cm long measuring instrument with the score range from 0 to 10 with 0 points showing "no anxiety" and 10 points showing "I feel a lot of anxiety"
Visual Analog Scale for Pain (VAS)	2 Hours	VAS scale is a single-dimensional scale that is commonly used to evaluate pain severity. According to VAS, pain intensity is rated as "no pain" with 0 points, and "the most severe pain imaginable" with 10 points. Pain intensity ranges were determined by VAS as follows; mild pain below 3 points, as moderate pain between 3 and 6 points, and as severe pain above 6 points.The VAS pain scale was applied to the patients once on the first postoperative day, for the level of pain they felt.

Secondary Outcome Measures

Name	Time	Method
Vital Signs	4 hours	SpO2 values of the patients will be measured with a finger type oximeter by the researchers.

Trial Locations

Locations (1)

Afyonkarahisar Health Sciences university Hospital; 🇹🇷 Afyonkarahisar, Turkey