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Clinical Trials/NCT04641052
NCT04641052
Completed
Not Applicable

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

Afyonkarahisar Health Sciences University1 site in 1 country70 target enrollmentNovember 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endoscopic Retrograde Cholangio-Pancreatography
Sponsor
Afyonkarahisar Health Sciences University
Enrollment
70
Locations
1
Primary Endpoint
Visual Analog Scale for Anxiety (VAS-A)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 24, 2020
End Date
February 11, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Afyonkarahisar Health Sciences University
Responsible Party
Principal Investigator
Principal Investigator

Yeliz Ciğerci

Assistant Proffesor PhD

Afyonkarahisar Health Sciences University

Eligibility Criteria

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

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)

Study Sites (1)

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