Virtual RealityNCT06311994
Applicability and Efficiency of Virtual Reality Intervention in Knee Surgery Patients
A study testing Virtual reality in people with Virtual Reality and Symptom Management, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Symptom Management, Surgery
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study,
- Being 18 years or older,
- This is the first time he's had knee surgery.
Who cannot join
- 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,
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- Do not have claustrophobia,
- Being under psychiatric treatment,
- There is no history of epilepsy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gumushane University
Gümüşhane, 28010
Aydanur Aydin, 0905321730688, aydanuraydin_88@hotmail.com
About this study
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.
- Conditions
- Virtual Reality, Symptom Management, Surgery, Quality of Life
- Being tested
- Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention with virtual reality | Experimental | 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. Receives: Device: Virtual reality |
| Control | No intervention | Among the randomized patients, patients included in the control group will be included in the conventional rehabilitation program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measure
VAS
Measured: 1 year
Stress
Distress termometer
Measured: 1 year
Secondary outcomes (2)
Mobilization
Tampa Kinesiophobia Scale
Measured: 1 year
Mobility
Patient Mobility Scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gümüşhane Universıty
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aydanur Aydin, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311994
- Sponsor's protocol ID
- GumushaneUni
- Status last verified
- Mar 2024
- First submitted
- 17 Feb 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 34264380Leon-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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability and Efficiency of Virtual Reality Intervention in Knee Surgery Patients
- ClinicalTrials.gov ID
- NCT06311994
- Acronym / sponsor ID
- GumushaneUni
- Conditions
- Virtual Reality, Symptom Management, Surgery, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gümüşhane UniversıtyUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention with virtual reality | Experimental | Device: Virtual realityFactors 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. |
| Control | No intervention | –Among the randomized patients, patients included in the control group will be included in the conventional rehabilitation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteering to participate in the study,
- Being 18 years or older,
- This is the first time he's had knee surgery.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityFactors 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. | Device | Intervention with virtual reality |
Primary outcome
Pain measure
Time frame: 1 year
VAS
Stress
Time frame: 1 year
Distress termometer
2 secondary outcomes
Mobilization
Time frame: 1 year
Mobility
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Results publication: PubMed 34264380Goh 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.
- Results publication: PubMed 37240897Leon-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Virtual Reality and Symptom Management, run by Gümüşhane Universıty at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aydanur Aydin (0905321730688, aydanuraydin_88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measure (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06311994, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.