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

Phase 4

• Conditions: Pain Post Joint Arthroplasty
• Interventions: Device: No VR glasses; Device: Virtual reality glasses

• Registration Number: NCT03311971
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study First Submitted: 2017-08-30
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-17
• Study Start: 2017-11-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-30
• Last Update Posted: 2018-09-04
• Primary Completion: 2018-09-30
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional therapy	No VR glasses	Patient undergoing conventional analgesic therapy after total knee replacement
Virtual reality glasses	Virtual reality glasses	Patient undergoing conventional analgesic therapy after total knee replacement and treated with virtual glasses

Primary Outcome Measures

Name	Time	Method
VAS pain response	One week	questionnaires

Secondary Outcome Measures

Name	Time	Method
Analgesic use	one week	amount of analgesic medication consumed

Trial Locations

Locations (1)

Hasharon Hospital; 🇮🇱 Petaẖ Tiqwa, Israel