The Effects Of Music In Endoscopic Retrograde Cholangiopancreatography Procedure

NCT04641052 | Completed

• 1 other identifier: 2020\481
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Endoscopic Retrograde Cholangio-Pancreatography; Anxiety; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Vital Signs

  4 Hours

• Vital Signs

  4 hours

• Vital Signs

  4 hours

Study Arms (2)

Music Intervention Group

EXPERIMENTAL

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

No Intervention Group

NO INTERVENTION

The control group patients will receive standard care only

Interventions

Music listening OTHER

The music type will be chosen by the patients and researchers will not have any influence on their choices.

Music Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences university Hospital

Afyonkarahisar, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yeliz CIGERCI, Phd

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffesor PhD

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: November 24, 2020
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)