Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee Arthroscope Surgery
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2018
CompletedFebruary 8, 2018
February 1, 2018
7 months
January 29, 2018
February 6, 2018
Conditions
Keywords
Outcome Measures
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.
postoperatively at 24 hours
Secondary Outcomes (1)
Visual analogue scale (VAS) for satisfaction
postoperatively at 24 hours
Study Arms (2)
VR group
EXPERIMENTALApplication of virtual reality 12 hours before arthroscopic surgery
Non-VR group
NO INTERVENTIONApplication of knee MRI 12 hours before arthroscopic surgery
Interventions
Eligibility Criteria
You may qualify if:
- Undergoing elective knee arthroscopy surgery
You may not qualify if:
- Infection, not willing to undergo study, mentally ill, severe osteoarthritis (KL grade III or more)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University Seoul Hospital
Seoul, South Korea
Related Publications (1)
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.
PMID: 31395176DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
JIN KYU M LEE
Hanyang University Seoul Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 8, 2018
Study Start
December 1, 2017
Primary Completion
June 15, 2018
Study Completion
August 15, 2018
Last Updated
February 8, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share