- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06311994
Applicability and Efficiency of Virtual Reality Intervention in Knee Surgery Patients
March 7, 2024 updated by: Aydanur Aydin, Gümüşhane Universıty
The stress experienced by patients in hospital environments can lead to a range of issues, from clinical decision-making to discharge.
Although stress levels can contribute to new problems, individual characteristics also play a significant role in clinical recovery.
Knee surgery is a commonly performed procedure in our country that provides patients with an effective solution to joint-related issues.
However, stress experienced by patients who undergo surgery can have negative consequences, from managing problems during their hospital stay to their overall quality of life.
The search for effective stress management methods is ongoing and has gained momentum with the development of new technological products.
Virtual reality (VR) applications are a novel approach in the literature for managing various issues.
Research is being conducted in different areas of our country using this approach.
The aim of this project is to evaluate the feasibility, acceptability, and effectiveness of different environment perceptions using virtual reality glasses on postoperative mobilization and well-being in individuals undergoing knee surgery for the first time.
The project sample is a randomized controlled trial consisting of 30 patients who will undergo orthopedic surgery for the first time at the Gümüşhane State Hospital orthopedic clinic and meet the acceptance criteria.
In the intervention group, patients will view relaxing virtual environment images with VR glasses after surgery.
Following the relaxation session, participants will be presented with content to exercise in the virtual environment.
Patients will be instructed to perform breathing exercises set in forest and underwater scenes to aid relaxation.
The effectiveness of the intervention will be assessed using the Tampa Kinesiophobia Scale and Patient Mobility Scale.
A satisfaction scale with a linear format will be used to evaluate the acceptability of the intervention.
In addition, a data collection form, developed by the researcher, will be used to gather information on participant characteristics.
The obtained data will be analyzed using t-tests, analysis of variance, correlation, and regression tests.
Currently, there is a growing number of studies that explore the relationship between technology and health.
This project aims to investigate the impact of virtual reality glasses on symptom management.
If the results are positive, this method could be used as a solution for various situations where individuals experience symptoms.
The goal is to develop a usable product for postoperative mobilization based on the research findings.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
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 Contact
- Name: Aydanur Aydin
- Phone Number: 0905321730688
- Email: aydanuraydin_88@hotmail.com
Study Locations
-
-
-
Gumushane, Turkey, 28010
- Recruiting
- Gümüşhane University
-
Contact:
- Aydanur Aydin
- Phone Number: 0905321730688
- Email: aydanuraydin_88@hotmail.com
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Volunteering to participate in the study,
- Being 18 years or older,
- This is the first time he's had knee surgery.
Exclusion Criteria:
- Not having a condition that prevents them from communicating, answering the questions asked in the research and participating in measurements,
- Having a physical problem that prevents arm movement (amputation, joint restriction in the extremities, etc.),
- Not having a chronic pain problem,
- Having hearing-vision problems,
- Having migraine, vertigo and active nausea problems,
- Do not have any problems (head wound, etc.) that would prevent the VR headset,
- Do not have claustrophobia,
- Being under psychiatric treatment,
- There is no history of epilepsy.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention with virtual reality
Factors that may affect patient compliance with the "VR-based intervention" method to be applied to patients undergoing knee surgery and the factors that may affect the measurements were evaluated through a literature review and inclusion and exclusion criteria were created.
|
Factors that may affect patient compliance with the "VR-based intervention" method to be applied to patients undergoing knee surgery and the factors that may affect the measurements to be performed were evaluated through a literature review and inclusion and exclusion criteria were created.
|
No Intervention: Control
Among the randomized patients, patients included in the control group will be included in the conventional rehabilitation program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain measure
Time Frame: 1 year
|
VAS
|
1 year
|
Stress
Time Frame: 1 year
|
Distress termometer
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobilization
Time Frame: 1 year
|
Tampa Kinesiophobia Scale
|
1 year
|
Mobility
Time Frame: 1 year
|
Patient Mobility Scale
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Goh GS, Lohre R, Parvizi J, Goel DP. Virtual and augmented reality for surgical training and simulation in knee arthroplasty. Arch Orthop Trauma Surg. 2021 Dec;141(12):2303-2312. doi: 10.1007/s00402-021-04037-1. Epub 2021 Jul 15.
- Leon-Munoz VJ, Moya-Angeler J, Lopez-Lopez M, Lison-Almagro AJ, Martinez-Martinez F, Santonja-Medina F. Integration of Square Fiducial Markers in Patient-Specific Instrumentation and Their Applicability in Knee Surgery. J Pers Med. 2023 Apr 25;13(5):727. doi: 10.3390/jpm13050727.
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)
February 1, 2024
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
February 17, 2024
First Submitted That Met QC Criteria
March 7, 2024
First Posted (Actual)
March 15, 2024
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 7, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- GumushaneUni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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