Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy

February 29, 2024 updated by: Seyma Yurtseven, Cukurova University

Virtual Reality Application for Pain and Anxiety Reduction During Cystoscopy: A Randomized Controlled Study

The aim of this research is to conduct a two-group randomized controlled intervention study to determine the effect of virtual reality applications on pain and anxiety during cystoscopy. The study population will consist of patients who have applied to the urology outpatient clinic of a University Hospital for cystoscopy. The study sample will be composed of patients who volunteer to participate in the study and meet the criteria during the planned dates of the research. Data will be collected using a 'Personal Information Form' created by the researcher through a literature review, the 'Visual Analog Scale' (VAS) for assessing pain, and the 'State Anxiety Inventory' (SAI) for assessing anxiety.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

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

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

Yes

Description

Inclusion Criteria:

  • Being literate,
  • Being conscious,
  • Ability to understand and speak Turkish and not have hearing or visual impairment,
  • Agreeing to participate in the research.

Exclusion Criteria:

  • Having a diagnosed psychiatric and mental illness,
  • Patients diagnosed with epilepsy (due to the risk of virtual reality glasses triggering epileptic seizures),
  • Patients who do not want to continue the study

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: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experiment group
Patients will wear virtual reality glasses 10 minutes before cystoscopy. The content chosen by the patient (there will be three options) will be watched throughout the procedure.
Other: virtual reality intervention
Patients will be shown content through the patient's virtual reality glasses throughout the cystoscopy procedure.
No Intervention: control group
Standard procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effect of virtual reality applications on pain during cystoscopy
Time Frame: 30 minutes after the procedure
The patient's pain will be assessed using the 'Visual Analog Scale (VAS).' This scale involves marking on a 10 cm vertical or horizontal line, with one end indicating no pain at all and the other end indicating the most severe pain, to assess and measure the level of pain.
30 minutes after the procedure
The effect of virtual reality applications on anxiety during cystoscopy
Time Frame: 30 minutes after the procedure
Procedure related anxiety will be assessed using the 'State Anxiety Inventory.' This inventory consists of a total of 20 items and the scoring ranges from 20 to 80 points. The higher the total score obtained from the scale, the higher the level of anxiety experienced by the individual is interpreted.
30 minutes after the procedure

Collaborators and Investigators

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

Sponsor

Cukurova 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)

October 10, 2023

Primary Completion (Estimated)

September 10, 2024

Study Completion (Estimated)

December 10, 2024

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

October 6, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5312256929

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

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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