Effect of Virtual Reality Glasses on Anxiety During Cystoscopy: A Randomised Controlled Trial

March 26, 2024 updated by: Uşak University
The aim of this study was to investigate the effect of using virtual reality glasses as a distraction method on anxiety in men undergoing cystoscopy under local anaesthesia.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

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 Contact

Study Contact Backup

Study Locations

  • Turkey
    • Center
      • Uşak, Center, Turkey, 64100
        • Recruiting
        • Uşak Training and Research Hospital
        • Contact:
        • Sub-Investigator:
          • Fatma Susam, PhD
        • Principal Investigator:
          • Yucel Can Danisman
        • Sub-Investigator:
          • Ozan Ozavci
        • Sub-Investigator:
          • Shahnaza Mahmudova
        • Sub-Investigator:
          • Erkan Arslan, MD
        • Sub-Investigator:
          • Adem Tuncekin, MD
        • Principal Investigator:
          • Bilgen Arikan, PhD

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:

  • Volunteering to participate in the research
  • 18 years of age or older
  • Male gender
  • undergoing a rigid cystoscopy procedure for the first time
  • Application of local anaesthesia

Exclusion Criteria:

  • Cognitive or physical disabilities that may prevent the use of virtual reality glasses.
  • Premedication before the procedure

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
This group will use virtual reality glasses during cystoscopy.
Device: virtual reality group
This group will use virtual reality glasses as distraction during cystoscopy.
No Intervention: controlled group
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiety
Time Frame: 30 minutes
State Trait Anxiety Scale-Situational Anxiety Scale
30 minutes

Collaborators and Investigators

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

Sponsor

Uşak University

Investigators

  • Principal Investigator: Yucel Can Danisman, Usak University Training and Research Hospital

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)

March 14, 2024

Primary Completion (Estimated)

June 15, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Virtual Reality

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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