Knee InjuriesNCT03426163
Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee Arthroscope Surgery
A study testing Virtual reality in people with Knee Injuries, run by Hanyang University Seoul Hospital at 1 site in South Korea.
Trial summary
Knee MRI is difficult for patients to understand as the image offers a single plane image. Accordingly,investigators sought to transfer the MRI image to 3-dimensional virtual reality system by Mesh rendering technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2017to 15 Aug 2018
- Phase
- Interventional
- 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
- Undergoing elective knee arthroscopy surgery
Who cannot join
- Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Seoul Hospital
Seoul
JIN KYU LEE
About this study
Official title: Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee: a Randomized Controlled Trial
Knee MRI is difficult for patients to understand as the image offers a single plane image. Accordingly,investigators sought to transfer the MRI image to 3-dimensional virtual reality system by Mesh rendering technique.
Read the detailed description
The primary outcome of the study is APAIS score assessed at 24 hours postoperation. Experimental VR group will be applied with virtual reality transformed knee MRI whereas no interverntion group will be applied with traditional knee MRI. MRI will be transformed to virtual reality images by Mesh rendering technique.
- Conditions
- Knee Injuries
- Being tested
- Virtual reality
- Keywords
- virtual reality, knee
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Application of knee MRI transformed virtual reality system
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Application of virtual reality 12 hours before arthroscopic surgery Receives: Device: Virtual reality |
| Non-VR group | No intervention | Application of knee MRI 12 hours before arthroscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Amsterdam perioperative anxiety and information scale (APAIS) score
surgery related anxiety and information score
Interpretation:
- minimum subscale scores: 2
- minimum combined anxiety component: 4
- maximum subscale scores: 10
- maximum combined anxiety component: 20
- The higher the scores the greater the degree of anxiety or need for additional information.
Measured: postoperatively at 24 hours
Secondary outcomes (1)
Visual analogue scale (VAS) for satisfaction
Satisfaction scale with a range of scores from 0-100. A higher score indicates greater satisfaction.
Measured: postoperatively at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start1 Dec 2017
- Primary completion15 Jun 2018 (estimated)
- Study completion15 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee InjuriesStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JIN KYU LEE, Hanyang University Seoul Hospital
- Investigators
- JIN KYU M LEE, Study chair, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426163
- Sponsor's protocol ID
- Hanyang University
- Status last verified
- Feb 2018
- First submitted
- 29 Jan 2018
- Last updated
- 8 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang JH, Ryu JJ, Nam E, Lee HS, Lee JK. Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. Arthroscopy. 2019 Aug;35(8):2394-2399. doi: 10.1016/j.arthro.2019.02.037.
PubMed 31395176
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03426163
- Acronym / sponsor ID
- Hanyang University
- Conditions
- Knee Injuries
- Keywords
- virtual reality, knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 15 Jun 2018 (estimated)
- Study completion
- 15 Aug 2018 (estimated)
- First posted
- 8 Feb 2018 (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.
Knee MRI is difficult for patients to understand as the image offers a single plane image. Accordingly,investigators sought to transfer the MRI image to 3-dimensional virtual reality system by Mesh rendering technique.
Detailed description
The primary outcome of the study is APAIS score assessed at 24 hours postoperation. Experimental VR group will be applied with virtual reality transformed knee MRI whereas no interverntion group will be applied with traditional knee MRI. MRI will be transformed to virtual reality images by Mesh rendering technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Virtual realityApplication of virtual reality 12 hours before arthroscopic surgery |
| Non-VR group | No intervention | –Application of knee MRI 12 hours before arthroscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing elective knee arthroscopy surgery
Key exclusion criteria (1 listed)
- Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)
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 realityApplication of knee MRI transformed virtual reality system | Device | VR group |
Primary outcome
The Amsterdam perioperative anxiety and information scale (APAIS) score
Time frame: postoperatively at 24 hours
surgery related anxiety and information score Interpretation: * minimum subscale scores: 2 * minimum combined anxiety component: 4 * maximum subscale scores: 10 * maximum combined anxiety component: 20 * The higher the scores the greater the degree of anxiety or need for additional information.
1 secondary outcome
Visual analogue scale (VAS) for satisfaction
Time frame: postoperatively at 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Derived from this study: PubMed 31395176Yang JH, Ryu JJ, Nam E, Lee HS, Lee JK. Effects of Preoperative Virtual Reality Magnetic Resonance Imaging on Preoperative Anxiety in Patients Undergoing Arthroscopic Knee Surgery: A Randomized Controlled Study. Arthroscopy. 2019 Aug;35(8):2394-2399. doi: 10.1016/j.arthro.2019.02.037.
- Individual participant dataSharing planned: No
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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.
JIN KYU M LEE study chair
Hanyang University Seoul Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Knee Injuries, run by Hanyang University Seoul Hospital at 1 site in South Korea.
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 1 inclusion and 1 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 8 Feb 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 South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact JIN KYU M LEE, Ph.D. (82-2-2290-8485, jklee77@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Amsterdam perioperative anxiety and information scale (APAIS) score (time frame: postoperatively at 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03426163, which also lists 1 linked publication.
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 8 Feb 2018.