Effects of Music Intervention on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale for Anxiety (VAS-A)
Study 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.
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 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
Yeliz Ciğerci
Assistant Proffesor PhD
Afyonkarahisar Health Sciences University