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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain Post Joint Arthroplasty

Intervention / Treatment
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* Device: Virtual reality glasses
* Device: No VR glasses


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison of intervention with conventional therapy. The intervention group includes use of virtual reality spectacles. The control group includes routine postoperative care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Conventional therapy<br>Patient undergoing conventional analgesic therapy after total knee replacement | Device: No VR glasses<br>* Patients will not use VR glasses<br>|
| Experimental: Virtual reality glasses<br>Patient undergoing conventional analgesic therapy after total knee replacement and treated with virtual glasses | Device: Virtual reality glasses<br>* Patients will be treated with virtual glasses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS pain response | questionnaires | One week | 

Secondary Outcome Measures

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