Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Extracorporeal Shock Wave Lithotripsy (ESWL)

November 26, 2025 updated by: Seda Cansu Yeniğün, Akdeniz University

Investigation of the Effect of Virtual Reality Glasses Used During Extracorporeal Shock Wave Lithotripsy (ESWL) on Patients' Pain, Anxiety, and Comfort Levels: A Randomized Controlled

Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During ESWL

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Samsun, Merkez, Turkey (Türkiye), 55070
        • Samsun Gazi State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Being 18 years of age or older, Having no hearing or perception impairments, Having no visual impairments, Undergoing ESWL for the first time.

Exclusion Criteria:

Use of any analgesic or anxiolytic medication before the procedure, Having a psychiatric disorder, The procedure being performed on an emergency basis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR-G (Virtual Reality Group) (1)
During the procedure, the patient will wear virtual reality glasses and watch a video. The video will be played through the virtual reality glasses throughout the entire procedure.
Behavioral: Virtual Reality Glasses
During the procedure, the patient will wear virtual reality glasses and watch a video. The video will be played through the virtual reality glasses throughout the entire procedure.
Other Names:
  • Control group
No Intervention: Control Group (2)
No intervention will be applied to the patients in the control group, and the standard care protocol of the clinic will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS
Time Frame: Data will be collected 10 minutes before the procedure.
Pain levels will be assessed.
Data will be collected 10 minutes before the procedure.
Visual Anxiety Scale (VAS-A)
Time Frame: Data will be collected 10 minutes before the procedure.
Anxiety levels will be assessed.
Data will be collected 10 minutes before the procedure.
Visual Comfort Scale
Time Frame: Data will be collected 10 minutes before the procedure.
Comfort levels will be assessed.
Data will be collected 10 minutes before the procedure.
Spielberger Trait Anxiety Inventory (STAI-II)
Time Frame: The measurement will be conducted only once, 10 minutes before the procedure.
It will be used to measure trait anxiety levels before the procedure.
The measurement will be conducted only once, 10 minutes before the procedure.
VAS
Time Frame: Data will be collected 30 minutes after the procedure.
Pain levels will be assessed.
Data will be collected 30 minutes after the procedure.
Visual Anxiety Scale (VAS-A)
Time Frame: Data will be collected 30 minutes after the procedure.
Anxiety levels will be assessed.
Data will be collected 30 minutes after the procedure.
Visual Comfort Scale
Time Frame: Data will be collected 30 minutes after the procedure.
Comfort levels will be assessed.
Data will be collected 30 minutes after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akdeniz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Scansuscansu92

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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