Single Center Study Evaluating the Possible Effect of Vir... | NCT03311971

Studies
Single Center Study Evaluating the Possible Effect of Virtual Reality Spectacles on Pain Following Total Knee Replacement Surgery

NCT03311971

Sponsor

Rabin Medical Center

Status

Unknown status

Last Update Posted

Sep 4, 2018Actual

Enrollment

50Estimated

Phase

Phase 4

Conditions

Pain Post Joint Arthroplasty

Interventions

Virtual reality glasses
No VR glasses

Countries

Israel

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2017Actual

Primary Completion Date

Sep 30, 2018Estimated

Completion Date

Jan 1, 2019Estimated

First Submitted Date

Aug 30, 2017

First Submission Date that Met QC Criteria

Oct 16, 2017

First Posted Date

Oct 17, 2017Actual

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

Aug 30, 2018

Last Update Posted Date

Sep 4, 2018Actual

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

The trial aims to evaulate the possiblity that use of virtual reality spectacles will affect post operative pain in total knee arthroplasty patients. The trial is a single center open label design. Patients will be randomized into two arm study comparing the effect of the use of virtual reality spectacles on pain levels and analgesic consumption in the perioperative period. The controls shall receive standard post operative care. The endpoints are VAS levels and analgesic use.

Detailed Description

Evaluation Procedure This is a single center, interventional, randomized, unblinded two arm study assessing pain and analgesic use in post knee arthroplasty patients. The randomization ratio is 2:1 intervention to control. Both groups will receive routine post operative care. The intervention group will be treated with virtual reality spectacles. The control group will receive routine post operative care. Pain levels will be assessed using VAS and analgesic use.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional therapy	Sham Comparator	Patient undergoing conventional analgesic therapy after total knee replacement	Device: No VR glasses
Virtual reality glasses	Experimental	Patient undergoing conventional analgesic therapy after total knee replacement and treated with virtual glasses	Device: Virtual reality glasses

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Virtual reality glasses	Device	Patients will be treated with virtual glasses	Virtual reality glasses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS pain response	questionnaires	One week

Secondary Outcomes

Measure	Description	Time Frame
Analgesic use	amount of analgesic medication consumed	one week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing total knee arthroplasty gender indifferent, aged over 18 years old
Patient with ability to see in three dimensions

Exclusion Criteria:

Inability to comply with the study protocol
Single eye vision
Blindness

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
Hasharon Hospital		Petah Tikva			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided