The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure

Study Overview
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Brief Summary
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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.

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

Conditions
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Endoscopic Retrograde Cholangio-Pancreatography, Anxiety, Pain

Intervention / Treatment
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* Other: Music listening


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Intervention Group<br>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. | Other: Music listening<br>* The music type will be chosen by the patients and researchers will not have any influence on their choices.<br>|
| No Intervention: No Intervention Group<br>The control group patients will receive standard care only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 Hour | 
| 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. | 2 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vital Signs | The systolic and diastolic blood pressure will be measured with  MICROLIFE BP A 150 AFIB device by the researchers. | 4 Hours | 
| Vital Signs | Heart rate values of the patients will be measured with a finger type oximeter by the researchers. | 4 hours | 
| Vital Signs | SpO2 values of the patients will be measured with a finger type oximeter by the researchers. | 4 hours |