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

NCT ID: NCT03311971

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-30
• Study Completion Date: 2019-01-01

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.

Conditions

Pain Post Joint Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional therapy

Patient undergoing conventional analgesic therapy after total knee replacement

Group Type: SHAM_COMPARATOR

No VR glasses

Intervention Type: DEVICE

Patients will not use VR glasses

Virtual reality glasses

Patient undergoing conventional analgesic therapy after total knee replacement and treated with virtual glasses

Group Type: EXPERIMENTAL

Virtual reality glasses

Intervention Type: DEVICE

Patients will be treated with virtual glasses

Interventions

Virtual reality glasses

Patients will be treated with virtual glasses

Intervention Type: DEVICE

No VR glasses

Patients will not use VR glasses

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

DROR ROBINSON

Head of orthopedic research unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hasharon Hospital

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

0428-17-RMC

Identifier Type: -

Identifier Source: org_study_id