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

Pain Post Joint Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03311971
• Other study ID #: 0428-17-RMC
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: November 30, 2017
• Est. completion date: January 1, 2019

Study information

• Verified date: August 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 1, 2019
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain Post Joint Arthroplasty

Intervention

Device:
• Virtual reality glasses
Patients will be treated with virtual glasses
• No VR glasses
Patients will not use VR glasses

Locations

Country	Name	City	State
Israel	Hasharon Hospital	Peta? Tiqwa

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain response	questionnaires	One week
Secondary	Analgesic use	amount of analgesic medication consumed	one week