Traditional Turkish Military Music and Endoscopic Retrograde Cholangiopancreatography

Sponsor
Afyonkarahisar Health Sciences University (Other)
Overall Status
Completed
CT.gov ID
NCT04641065
Collaborator
(none)
72
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Study Details

Study Description

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=64) and control group (n=64). 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Music listening
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Traditional Turkish Military Music on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Music Intervention Group

The music intervention group will be listened to Traditional Turkish Military music by the researchers for the duration of 15 minutes before the procedure as well as the standard care.

Other: Music listening
An expert on the particular type of music will do the selection of the playlist of Traditional Turkish Military music, and this playlist will be listened to the patients by the researchers.

No Intervention: No Intervention Group

The control group patients will receive standard care only

Outcome Measures

Primary Outcome Measures

  1. 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"

  2. 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

  1. Vital Signs [4 Hours]

    The systolic and diastolic blood pressure will be measured with " MICROLIFE BP A 150 AFIB" device by the researchers.

  2. Vital Signs [4 hours]

    Heart rate values of the patients will be measured with a finger type oximeter by the researchers.

  3. Vital Signs [4 hours]

    SpO2 values of the patients will be measured with a finger type oximeter by the researchers.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Afyonkarahisar Health Sciences University Hospital, Afyonkarahisar Turkey

Sponsors and Collaborators

  • Afyonkarahisar Health Sciences University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yeliz Ciğerci, Assistant Professor PhD, Afyonkarahisar Health Sciences University
ClinicalTrials.gov Identifier:
NCT04641065
Other Study ID Numbers:
  • 2020\482
First Posted:
Nov 23, 2020
Last Update Posted:
Jul 13, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 13, 2021