The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04641052
• Other study ID #: 2020\481
• Status: Completed
• Phase: N/A
• Start date: November 24, 2020
• Est. completion date: February 11, 2021

Study information

• Verified date: December 2022
• Source: Afyonkarahisar Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 11, 2021
• Est. primary completion date: February 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Endoscopic Retrograde Cholangio-Pancreatography
• Pain

Intervention

Other:
• Music listening
The music type will be chosen by the patients and researchers will not have any influence on their choices.

Locations

Country	Name	City	State
Turkey	Afyonkarahisar Health Sciences university Hospital	Afyonkarahisar

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Vital Signs	The systolic and diastolic blood pressure will be measured with " MICROLIFE BP A 150 AFIB" device by the researchers.	4 Hours
Secondary	Vital Signs	Heart rate values of the patients will be measured with a finger type oximeter by the researchers.	4 hours
Secondary	Vital Signs	SpO2 values of the patients will be measured with a finger type oximeter by the researchers.	4 hours