The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure

Effects of Music Intervention on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Endoscopic Retrograde Cholangio-Pancreatography
• Intervention / Treatment: Other: Music listening

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Afyonkarahisar, Turkey
    • Afyonkarahisar Health Sciences university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Music listening; The music type will be chosen by the patients and researchers will not have any influence on their choices.
No Intervention: No Intervention Group; The control group patients will receive standard care only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for Anxiety (VAS-A)	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"	1 Hour
Visual Analog Scale for Pain (VAS)	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.	2 Hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Signs	The systolic and diastolic blood pressure will be measured with " MICROLIFE BP A 150 AFIB" device by the researchers.	4 Hours
Vital Signs	Heart rate values of the patients will be measured with a finger type oximeter by the researchers.	4 hours
Vital Signs	SpO2 values of the patients will be measured with a finger type oximeter by the researchers.	4 hours

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University
• Investigators: Principal Investigator: Yeliz CIGERCI, Phd, Afyonkarahisar Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): February 11, 2021
• Study Completion (Actual): February 11, 2021

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 19, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Estimate): January 4, 2023
• Last Update Submitted That Met QC Criteria: December 30, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2020\481

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No