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Status unknownNCT03426163Updated Feb 8, 2018

Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee Arthroscope Surgery

An interventional study of Virtual reality in Knee Injuries, sponsored by Hanyang University Seoul Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-08.

Sponsored by Hanyang University Seoul Hospital · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Knee Injuries

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Keywords

  • virtual reality
  • knee
03

In context

Knee Injuries

267 studies on the registry are indexed under Knee Injuries; 59 are open to participants now.

This study's planned enrollment of 48 is close to the median of 49 across 178 interventional studies indexed under Knee Injuries.

Browse Knee Injuries studies →

Lead sponsor

Hanyang University Seoul Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Undergoing elective knee arthroscopy surgery

Exclusion criteria

Exclusion Criteria:

  • Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    VR group

    Application of virtual reality 12 hours before arthroscopic surgery

    Device: Virtual reality

  • No intervention
    Non-VR group

    Application of knee MRI 12 hours before arthroscopic surgery

Interventions

  • DeviceVirtual reality

    Application of knee MRI transformed virtual reality system

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: postoperatively at 24 hours

07

Study locations

1 of 1 sites recruiting
  • Hanyang University Seoul Hospital
    Seoul, Korea, Republic of
    Recruiting
    • JIN KYU LEE · Contact
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Jun 2018, 6 months after the start.

Of 94 non-industry interventional studies with no phase under Knee Injuries, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 51. This study's planned 6 months is below that.

Counting every sponsor, half of 99 studies reached it within 20 months; a quarter within 8 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 29, 2018
First posted
Feb 8, 2018
StartActual
Dec 1, 2017
Primary completionEst.
Jun 15, 2018
CompletionEst.
Aug 15, 2018
Last update
Feb 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03426163
Lead sponsor
Hanyang University Seoul Hospital
Responsible party
JIN KYU LEE (Assistant Professor, Hanyang University Seoul Hospital) — Principal investigator
First posted
Feb 8, 2018
Start date
Dec 1, 2017
Primary completion
Jun 15, 2018 (estimated)
Completion
Aug 15, 2018 (estimated)
Last update
Feb 8, 2018

Study contacts

JIN KYU M LEE, Ph.D.
Contact
jklee77@hanyang.ac.kr
82-2-2290-8485
JIN KYU M LEE
study chair · Hanyang University Seoul Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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