The Effect Of Virtual Reality Glasses On Pain And Anxiety During The Kidney Stone Lithotripsy Procedure
October 4, 2024 updated by: Aysegul Gunes, University of Beykent
The Effect Of Virtual Realty Glasses On Pain And Anxiety During The Kidney Stone Lithotripsy Procedure
To determine the pain and anxiety levels of patients using virtual reality glasses during the extracorporeal shock wave lithotripsy procedure.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
This randomized clinical trial included 60 patients with lithotripsy procedure.
The research group of 60 people was divided into two groups, 30 in the experimental group and 30 in the control group.
While the standard stone crushing process was applied to the control group, the experimental group was watched with virtual reality glasses during the procedure.
The State-Trait Anxiety Inventory and the Numerical Rating Scale, which was used to measure the level of pain and anxiety level.
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Istanbul, Turkey
- Istanbul Beykent University
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-
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
- Performing ESWL procedure
Exclusion criteria
- Presence of psychiatric disease
- Vision problem
- Hearing problem
- Drug and alcohol addiction
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR group
Use of VR glasses during the procedure
|
the experimental group was shown a video through VRG during the lithotripsy procedure.
|
|
Active Comparator: Control Group
Standart care group
|
Patients received standard care during the procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Scale
Time Frame: During ESWL procedure
|
Pain level during the procedure
|
During ESWL procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Guitynavard F, Azadvari M, Gholamnejad M, et al. Decreasing discomfort during shock-wave lithotripsy using transcutaneous electrical nerve stimulation. Translational Research in Urology. 2022; 4(2): 71-76
- Lei M, Li G, Tang Y, Yuan J, Yang T, Gao Z. Efficacy of music therapy for pain control of extracorporeal shock wave lithotripsy: A meta-analysis of randomized controlled studies. Medicine (Baltimore). 2024 May 31;103(22):e38182. doi: 10.1097/MD.0000000000038182.
- Ozsaker E, Diramali A. The effect of transcutaneous electrical nerve stimulation for pain relief during extracorporeal shock-wave lithotripsy procedure. Pain Manag Nurs. 2014 Mar;15(1):59-68. doi: 10.1016/j.pmn.2012.06.003. Epub 2012 Aug 18.
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)
July 25, 2021
Primary Completion (Actual)
February 10, 2022
Study Completion (Estimated)
November 10, 2024
Study Registration Dates
First Submitted
October 2, 2024
First Submitted That Met QC Criteria
October 4, 2024
First Posted (Actual)
October 8, 2024
Study Record Updates
Last Update Posted (Actual)
October 8, 2024
Last Update Submitted That Met QC Criteria
October 4, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Istanbul Beykent University
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This was a masters thesis research, and the computer used to collect data at that time was damaged.
Communication could not be established with the statistician who conducted the data analysis.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.