Effect of Virtual Glasses on Pain and Comfort During ESWL

NCT05842668 | Withdrawn

• 1 other identifier: Lecturer-11412
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Extracorporeal Shock Wave Lithotripsy; Lithotripsy

Keywords

ESWL; Pain; comfort level; virtual glasses

Outcome Measures

Primary Outcomes (2)

• Comfort Score

  The response patterns of the scale, which consists of positive and negative items, are given in a mixed form. A high score for positive items (4) indicates high comfort, a low score (1) indicates low comfort, and a low score (1 point) for negative items indicates high comfort, and a high score (4 points) indicates low comfort. While evaluating the scale, the negative scores obtained are reverse coded and added together with the positive items. The maximum total score that can be obtained from the scale is 192, and the minimum total score is 48.

  5-10 minutes before ESWL

• Pain Score (Visual analog Score)

  Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no pain and "10" means the most severe pain. The patient marks the intensity of pain he feels on the ruler. If the marked value is between 1-4, it indicates mild pain, between 5-6 indicates moderate pain, and between 7-10 indicates severe pain. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.

  5-10 minutes before ESWL

Secondary Outcomes (2)

• Comfort Score

  15 minutes after ESWL

• Pain Score (Visual analog Score)

  15 minutes after ESWL

Study Arms (2)

ESWL Group

EXPERIMENTAL

Behavioral: ESWL Group

Control Group

NO INTERVENTION

Interventions

ESWL Group BEHAVIORAL

Increasing comfort and reducing pain during ESWL

ESWL Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Akdeniz University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: April 20, 2023
• First Posted: May 6, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 16, 2024
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share