The Effect Of Virtual Reality Glasses On Pain And Anxiety... | NCT06629727

Studies
The Effect Of Virtual Reality Glasses On Pain And Anxiety During The Kidney Stone Lithotripsy Procedure

NCT06629727

Sponsor

University of Beykent

Status

Active, not recruiting

Last Update Posted

Oct 8, 2024Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Pain Management
Extracorporeal Shock Wave Lithotripsy
Virtual Reality

Interventions

VR Group
Control 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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2021Actual

Primary Completion Date

Feb 10, 2022Actual

Completion Date

Nov 10, 2024Estimated

First Submitted Date

Oct 2, 2024

First Submission Date that Met QC Criteria

Oct 4, 2024

First Posted Date

Oct 8, 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

Oct 4, 2024

Last Update Posted Date

Oct 8, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aysegul Gunes, Health Science Faculty Vice - Dean (PhD. RN.), University of BeykentPrincipal Investigator

Lead Sponsor

University of BeykentOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To determine the pain and anxiety levels of patients using virtual reality glasses during the extracorporeal shock wave lithotripsy procedure.

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.

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VR group	Experimental	Use of VR glasses during the procedure	Other: VR Group
Control Group	Active Comparator	Standart care group	Other: Control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VR Group	Other	the experimental group was shown a video through VRG during the lithotripsy procedure.	VR group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Numeric Pain Scale	Pain level during the procedure	During ESWL procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

- Performing ESWL procedure

Exclusion criteria

Presence of psychiatric disease
Vision problem
Hearing problem
Drug and alcohol addiction

Accepts Healthy Volunteers

Sex

All

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Beykent University		Istanbul			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation
	Result	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
39259054	Result	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.
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ID	Term
D000377	Agnosia
D010146	Pain
D001008	Anxiety Disorders

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design