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

Knee Injuries Clinical Trial

Official title:

Effect of Preoperative MRI Virtual Reality in Patients Undergoing Knee: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03426163
• Other study ID #: Hanyang University
• Status: Recruiting
• Phase: N/A
• First received: January 29, 2018
• Last updated: February 6, 2018
• Start date: December 1, 2017
• Est. completion date: August 15, 2018

Study information

• Verified date: February 2018
• Source: Hanyang University Seoul Hospital
• Contact: JIN KYU M LEE, Ph.D.
• Phone: 82-2-2290-8485
• Email: jklee77[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: August 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Undergoing elective knee arthroscopy surgery

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Knee Injuries

Intervention

Device:
• Virtual reality
Application of knee MRI transformed virtual reality system

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual analogue scale (VAS) for satisfaction	Satisfaction scale with a range of scores from 0-100. A higher score indicates greater satisfaction.	postoperatively at 24 hours