- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03311971
Single Center Study Evaluating the Possible Effect of Virtual Reality Spectacles on Pain Following Total Knee Replacement Surgery
August 30, 2018 updated by: DROR ROBINSON, Rabin Medical Center
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Petaẖ Tiqwa, Israel
- Hasharon Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Conventional therapy
Patient undergoing conventional analgesic therapy after total knee replacement
|
Patients will not use VR glasses
|
Experimental: Virtual reality glasses
Patient undergoing conventional analgesic therapy after total knee replacement and treated with virtual glasses
|
Patients will be treated with virtual glasses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS pain response
Time Frame: One week
|
questionnaires
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesic use
Time Frame: one week
|
amount of analgesic medication consumed
|
one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2017
Primary Completion (Anticipated)
September 30, 2018
Study Completion (Anticipated)
January 1, 2019
Study Registration Dates
First Submitted
August 30, 2017
First Submitted That Met QC Criteria
October 16, 2017
First Posted (Actual)
October 17, 2017
Study Record Updates
Last Update Posted (Actual)
September 4, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- 0428-17-RMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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