CClinicalTrials.gg
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has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.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

Browse trials for

Keywords

  • virtual reality
  • knee
03

Who can participate

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

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)
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Hanyang University Seoul Hospital
    Seoul, Korea, Republic of
    • JIN KYU LEE · Contact
    Recruiting
07

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

08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion