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

February 6, 2018 updated by: JIN KYU LEE, Hanyang University Seoul Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Hanyang University Seoul Hospital
        • Contact:
          • JIN KYU LEE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing elective knee arthroscopy surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR group
Application of virtual reality 12 hours before arthroscopic surgery
Device: Virtual reality
Application of knee MRI transformed virtual reality system
No Intervention: Non-VR group
Application of knee MRI 12 hours before arthroscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperatively at 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS) for satisfaction
Time Frame: postoperatively at 24 hours
Satisfaction scale with a range of scores from 0-100. A higher score indicates greater satisfaction.
postoperatively at 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University Seoul Hospital

Investigators

  • Study Chair: JIN KYU M LEE, Hanyang University Seoul Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

June 15, 2018

Study Completion (Anticipated)

August 15, 2018

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2018

Last Update Submitted That Met QC Criteria

February 6, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hanyang University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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