The Effects Of Music In Retrograde Intrarenal Surgery

The Effects Of Music Listening In Patients Undergoing Retrograde Intrarenal Surgery On Basic Life Findings, Anxiety, Pain, And The Amount Of Analgesic Used.

This study aimed to investigate the effect of music listening during the preoperative and postoperative stages in patients undergoing retrograde intrarenal surgery(RIRS) on basic life findings, anxiety, pain, and the amount of analgesic used. This is a randomized controlled experimental study.

The study was conducted with two groups: the intervention group (n=30) and control group (n=30). The control group received standard care. In contrast, the intervention group, in addition to standard care, was listened to the music by the researchers for 15 minutes one hour before their surgery.

Study Overview

• Status: Completed
• Conditions: Retrograde Intrarenal Surgery
• Intervention / Treatment: Other: Music Listening

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Centre
    • Afyonkarahisar, Centre, Turkey, 03200
      • Afyonkarahisar Health Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or above,
• had elective RIRS,
• without hearing/speech impairment,
• without mental problems,
• without a diagnosis of psychiatric disorders,
• without a diagnosis of depression,
• had the surgery under general anesthesia,
• and volunteered to participate.

Exclusion Criteria:

• Patients under 18 years of age,
• with hearing/speech impairment,
• with mental problems,
• with a diagnosis of psychiatric disorders,
• with a diagnosis of depression,
• undergoing the surgery through spinal anesthesia,
• not willing to participate in the study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music Intervention Group; The music intervention group listened to the music by the researchers for the duration of 15 minutes one hour before the surgery as well as the standard care.	Other: Music Listening; The music type was chosen by the patients and researchers did not have any influence on their choices.
No Intervention: No Intervention Group; The control group patients received standard care only.

What is the study measuring?

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" .	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: Afyonkarahisar Health Sciences University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 2, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 4, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: (2019/165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No