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RecruitingNCT06311994Updated Jul 11, 2024

Applicability and Efficiency of Virtual Reality Intervention in Knee Surgery Patients

An interventional study of Virtual reality in Virtual Reality, Symptom Management and Surgery, sponsored by Gümüşhane Universıty. Recruiting at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-11.

Sponsored by Gümüşhane Universıty · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Virtual Reality
  • Symptom Management
  • Surgery
  • Quality of Life
03

In context

Lead sponsor

Gümüşhane Universıty is the lead sponsor of 34 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • 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.

    Device: Virtual reality

  • No intervention
    Control

    Among the randomized patients, patients included in the control group will be included in the conventional rehabilitation program.

Interventions

  • DeviceVirtual 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 to be performed were evaluated through a literature review and inclusion and exclusion criteria were created.

06

What researchers measure

Primary outcomes

  1. Pain measure

    VAS

    Time frame: 1 year

  2. Stress

    Distress termometer

    Time frame: 1 year

Secondary outcomes

  1. Mobilization

    Tampa Kinesiophobia Scale

    Time frame: 1 year

  2. Mobility

    Patient Mobility Scale

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 34264380 ↗
  • 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. PubMed 37240897 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06311994
Lead sponsor
Gümüşhane Universıty
Responsible party
Aydanur Aydin (Assist.Prof.Dr., Gümüşhane Universıty) — Principal investigator
First posted
Mar 15, 2024
Start date
Feb 1, 2024
Primary completion
Dec 1, 2024 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Jul 11, 2024

Study contacts

Aydanur Aydin
Contact
aydanuraydin_88@hotmail.com
0905321730688

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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