Back to resultsThe Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure
Primary Purpose
Endoscopic Retrograde Cholangio-Pancreatography, Anxiety, Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music listening
Sponsored by
About this trial
This is an interventional supportive care trial for Endoscopic Retrograde Cholangio-Pancreatography
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
Sites / Locations
- Afyonkarahisar Health Sciences university Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Music Intervention Group
No Intervention Group
Arm Description
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.
The control group patients will receive standard care only
Outcomes
Primary Outcome Measures
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"
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.
Secondary Outcome Measures
Vital Signs
The systolic and diastolic blood pressure will be measured with " MICROLIFE BP A 150 AFIB" device by the researchers.
Vital Signs
Heart rate values of the patients will be measured with a finger type oximeter by the researchers.
Vital Signs
SpO2 values of the patients will be measured with a finger type oximeter by the researchers.
Full Information
NCT ID
NCT04641052
First Posted
November 17, 2020
Last Updated
December 30, 2022
Sponsor
Afyonkarahisar Health Sciences University
1. Study Identification
Unique Protocol Identification Number
NCT04641052
Brief Title
The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure
Official Title
Effects of Music Intervention on Pain, Anxiety and Vital Signs in Patients With Endoscopic Retrograde Cholangiopancreatography
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
February 11, 2021 (Actual)
Study Completion Date
February 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Afyonkarahisar Health Sciences University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endoscopic Retrograde Cholangio-Pancreatography, Anxiety, Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No Intervention Group
Arm Type
No Intervention
Arm Description
The control group patients will receive standard care only
Intervention Type
Other
Intervention Name(s)
Music listening
Intervention Description
The music type will be chosen by the patients and researchers will not have any influence on their choices.
Primary Outcome Measure Information:
Title
Visual Analog Scale for Anxiety (VAS-A)
Description
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"
Time Frame
1 Hour
Title
Visual Analog Scale for Pain (VAS)
Description
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.
Time Frame
2 Hours
Secondary Outcome Measure Information:
Title
Vital Signs
Description
The systolic and diastolic blood pressure will be measured with " MICROLIFE BP A 150 AFIB" device by the researchers.
Time Frame
4 Hours
Title
Vital Signs
Description
Heart rate values of the patients will be measured with a finger type oximeter by the researchers.
Time Frame
4 hours
Title
Vital Signs
Description
SpO2 values of the patients will be measured with a finger type oximeter by the researchers.
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yeliz CIGERCI, Phd
Organizational Affiliation
Afyonkarahisar Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Afyonkarahisar Health Sciences university Hospital
City
Afyonkarahisar
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure
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