NCT06342193

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2024

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

April 2, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 26, 2024

Last Update Submit

March 26, 2024

Conditions

CystoscopyVirtual RealityAnxiety

Outcome Measures

Primary Outcomes (1)

  • anxiety

    State Trait Anxiety Scale-Situational Anxiety Scale

    30 minutes

Study Arms (2)

intervention group

EXPERIMENTAL

This group will use virtual reality glasses during cystoscopy.

Device: virtual reality group

controlled group

NO INTERVENTION

No intervention

Interventions

virtual reality groupDEVICE

This group will use virtual reality glasses as distraction during cystoscopy.

intervention group

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Usak Training and Research Hospital

Uşak, Center, 64100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Yucel Can Danisman

    Usak University Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bilgen Arikan, PhD

CONTACT

+902762212121blgnkhy@gmail.com

Yucel Can Danisman

CONTACT

+905532864569202201023@ogr.usak.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

March 14, 2024

Primary Completion

June 15, 2024

Study Completion

June 15, 2024

Last Updated

April 2, 2024

Record last verified: 2024-03

Locations

TU(1)