Pain Post Joint ArthroplastyPhase 4NCT03311971
Single Center Study Evaluating the Possible Effect of Virtual Reality Spectacles on Pain Following Total Knee Replacement Surgery
A Phase 4 study testing Virtual reality glasses and No VR glasses in people with Pain Post Joint Arthroplasty, run by Rabin Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Post Joint Arthroplasty
- What is being tested?
- Virtual reality glasses and No VR glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Nov 2017to 1 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee arthroplasty gender indifferent, aged over 18 years old
- Patient with ability to see in three dimensions
Who cannot join
- Inability to comply with the study protocol
- Single eye vision
- Blindness
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Virtual reality glasses, No VR glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality glassesDevice
Patients will be treated with virtual glasses
No VR glassesDevice
Patients will not use VR glasses
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Sham comparator | Patient undergoing conventional analgesic therapy after total knee replacement Receives: Device: No VR glasses |
| Virtual reality glasses | Experimental | Patient undergoing conventional analgesic therapy after total knee replacement and treated with virtual glasses Receives: Device: Virtual reality glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain response
questionnaires
Measured: One week
Secondary outcomes (1)
Analgesic use
amount of analgesic medication consumed
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start30 Nov 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Post Joint ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DROR ROBINSON, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311971
- Sponsor's protocol ID
- 0428-17-RMC
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2017
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Study Evaluating the Possible Effect of Virtual Reality Spectacles on Pain Following Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT03311971
- Acronym / sponsor ID
- 0428-17-RMC
- Conditions
- Pain Post Joint Arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of intervention with conventional therapy. The intervention group includes use of virtual reality spectacles. The control group includes routine postoperative care
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Sham comparator | Device: No VR glassesPatient undergoing conventional analgesic therapy after total knee replacement |
| Virtual reality glasses | Experimental | Device: Virtual reality glassesPatient undergoing conventional analgesic therapy after total knee replacement and treated with virtual glasses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing total knee arthroplasty gender indifferent, aged over 18 years old
- Patient with ability to see in three dimensions
Key exclusion criteria (3 listed)
- Inability to comply with the study protocol
- Single eye vision
- Blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality glassesPatients will be treated with virtual glasses | Device | Virtual reality glasses |
| No VR glassesPatients will not use VR glasses | Device | Conventional therapy |
Primary outcome
VAS pain response
Time frame: One week
questionnaires
1 secondary outcome
Analgesic use
Time frame: one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Virtual reality glasses and No VR glasses in people with Pain Post Joint Arthroplasty, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain response (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018; AzTrials last refreshed its copy on 2 Nov 2026.