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

Clalit Health Services

Status and phase: Unknown; Phase 4

Conditions: Pain Post Joint Arthroplasty

Treatments: Device: Virtual reality glasses; Device: No VR glasses

Study type: Interventional

Funder types: Other

Identifiers

NCT03311971

0428-17-RMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Conventional therapy

Sham Comparator group

Description:

Patient undergoing conventional analgesic therapy after total knee replacement

Treatment:

Device: No VR glasses

Virtual reality glasses

Experimental group

Description:

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

Treatment:

Device: Virtual reality glasses