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

Primary Purpose

Knee Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Hanyang University Seoul Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Knee Injuries focused on measuring virtual reality, knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing elective knee arthroscopy surgery

Exclusion Criteria:

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

Sites / Locations

  • Hanyang University Seoul HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VR group

Non-VR group

Arm Description

Application of virtual reality 12 hours before arthroscopic surgery

Application of knee MRI 12 hours before arthroscopic surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual analogue scale (VAS) for satisfaction
Satisfaction scale with a range of scores from 0-100. A higher score indicates greater satisfaction.

Full Information

First Posted
January 29, 2018
Last Updated
February 6, 2018
Sponsor
Hanyang University Seoul Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03426163
Brief Title
Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee Arthroscope Surgery
Official Title
Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 15, 2018 (Anticipated)
Study Completion Date
August 15, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University Seoul Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
virtual reality, knee

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR group
Arm Type
Experimental
Arm Description
Application of virtual reality 12 hours before arthroscopic surgery
Arm Title
Non-VR group
Arm Type
No Intervention
Arm Description
Application of knee MRI 12 hours before arthroscopic surgery
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
Application of knee MRI transformed virtual reality system
Primary Outcome Measure Information:
Title
The Amsterdam perioperative anxiety and information scale (APAIS) score
Description
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 Outcome Measure Information:
Title
Visual analogue scale (VAS) for satisfaction
Description
Satisfaction scale with a range of scores from 0-100. A higher score indicates greater satisfaction.
Time Frame
postoperatively at 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing elective knee arthroscopy surgery Exclusion Criteria: Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JIN KYU M LEE, Ph.D.
Phone
82-2-2290-8485
Email
jklee77@hanyang.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JIN KYU M LEE
Organizational Affiliation
Hanyang University Seoul Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Hanyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JIN KYU LEE

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31395176
Citation
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.
Results Reference
derived

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

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