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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04500054
Other study ID # (2019/165
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 14, 2019
Est. completion date December 31, 2019

Study information

Verified date August 2020
Source Afyonkarahisar University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Music Listening
The music type was chosen by the patients and researchers did not have any influence on their choices.

Locations

Country Name City State
Turkey Afyonkarahisar Health Science University Afyonkarahisar Centre

Sponsors (1)

Lead Sponsor Collaborator
Afyonkarahisar University of Health Sciences

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" . 2 days
Secondary 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
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