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Clinical Trials/NCT04641065
NCT04641065CompletedNot Applicable

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

Afyonkarahisar Health Sciences University1 site in 1 country72 target enrollmentStarted: March 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
72
Locations
1
Primary Endpoint
Visual Analog Scale for Anxiety (VAS-A)

Study Overview

Brief Summary

This study aims to investigate the effect of Traditional Turkish Military music 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=36) and the control group (n=36). The control group will receive standard care while the intervention group, in addition to standard care, will be listened to Traditional Turkish Military music, which consists of music selected by an expert on the type of music, by the researchers for 15 minutes before the procedure.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 below 18 years of age,
  • 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

Outcomes

Primary Outcomes

Visual Analog Scale for Anxiety (VAS-A)

Time Frame: 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)

Time Frame: 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 Outcomes

  • Vital Signs(4 hours)

Investigators

Sponsor
Afyonkarahisar Health Sciences University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yeliz Ciğerci

Assistant Professor PhD

Afyonkarahisar Health Sciences University

Study Sites (1)

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