Effect of Virtual Reality Glasses on Anxiety During Cysto... | NCT06342193

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

NCT06342193

Sponsor

Uşak University

Status

Unknown status

Last Update Posted

Apr 2, 2024Actual

Enrollment

54Estimated

Phase

Not Applicable

Conditions

Cystoscopy
Virtual Reality
Anxiety

Interventions

virtual reality group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2024Actual

Primary Completion Date

Jun 15, 2024Estimated

Completion Date

Jun 15, 2024Estimated

First Submitted Date

Mar 26, 2024

First Submission Date that Met QC Criteria

Mar 26, 2024

First Posted Date

Apr 2, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2024

Last Update Posted Date

Apr 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental	This group will use virtual reality glasses during cystoscopy.	Device: virtual reality group
controlled group	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
virtual reality group	Device	This group will use virtual reality glasses as distraction during cystoscopy.	intervention group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bilgen Arikan, PhD	Contact	+902762212121	3081	blgnkhy@gmail.com
Yucel Can Danisman	Contact	+905532864569		202201023@ogr.usak.edu.tr

Overall Officials

Name	Affiliation	Role
Yucel Can Danisman	Usak University Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Usak Training and Research Hospital	Recruiting	Uşak	Center	64100	Turkey (Türkiye)