Effect of Virtual Glasses on Pain and Comfort During ESWL

NCT ID: NCT05842668

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-03-16

Brief Summary

The aim of this study is to examine the effect of virtual glasses application on the patient's pain and comfort level during ESWL.

The data obtained in the research will be analyzed using the SPSS 23.0 "Statistical Package for Social Sciences" for Windows program. Descriptive statistical methods when evaluating data; number, percentage, mean, frequency, standard deviation will be used. As hypothesis tests, analysis will be made with Mann Whitney U, student t test, and chi-square tests. The findings will be interpreted with a significance level of 0.05 at the 95% confidence interval.

Detailed Description

After obtaining the permission of the ethics committee and institution of the study, the researcher will go to the clinic and introduce himself to the patient who is admitted to undergo ESWL procedure and explain the purpose of the research. Informed consent will be obtained from patients who volunteered to participate in the study. The data on the socio-demographic characteristics of the patients in the patient introduction form will be interviewed face-to-face with the patient, and the data on the clinical characteristics of the patients will be recorded from the patient file. Data will be collected from the first patient who will undergo the ESWL procedure. Pain with VAS and comfort level with General comfort scale will be checked 5-10 minutes before the procedure. According to the randomization, the patient in the virtual glasses group will first be explained to the patient by the researcher that he will wear the glasses for 30 minutes during the procedure and watch the video. When the 30 minutes are up, the patient will be informed by the researcher and the glasses will be removed. No intervention will be performed on the patient in the control group. The first patient will go to the operation room. Patients in the virtual glasses group will use the virtual glasses for 30 minutes after the patient goes to the operating table and the preparation is completed. No intervention will be performed on the patient in the control group. All patient groups will be checked for pain with VAS and comfort level with general comfort scale 30 minutes after the end of the procedure. At the end of the procedure, the patient will come to the service. No intervention will be done to the patients in the control group, and the routine care protocol of the clinic will be applied.

Conditions

Extracorporeal Shock Wave Lithotripsy; Lithotripsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ESWL Group

Group Type: EXPERIMENTAL

ESWL Group

Intervention Type: BEHAVIORAL

Increasing comfort and reducing pain during ESWL

Control Group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ESWL Group

Increasing comfort and reducing pain during ESWL

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years or older,
• Absence of hearing and perception problems,
• Absence of any visual impairment,
• ESWL procedure will be performed for the first time,

Exclusion Criteria

• Using any analgesic or anxiolytic before the procedure,
• Having a psychiatric disorder

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Akdeniz University

OTHER

Sponsor Role: lead

Responsible Party

Seda Cansu Yeniğün

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Lecturer-11412

Identifier Type: -

Identifier Source: org_study_id