AnxietyNCT06792123
Effect of Virtual Reality Application Applied to Patients With Total Knee Replacement at Different Times
A study testing pre-op VR application group and intra-op VR application group in people with Anxiety and Recovery Quality, run by Özge İşeri at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Recovery Quality
- What is being tested?
- pre-op VR application group and intra-op VR application group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2024to 30 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 18
- No psychiatric medication
- No mental and cognitive disabilities
- Those who underwent Total Knee Replacement,
Who cannot join
- Patients with visual and hearing impairment
- Receiving general anesthesia
- Experiencing complications during surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Application Applied to Patients With Total Knee Replacement at Different Times on Anxiety and Recovery Quality
The aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement.
Read the detailed description
The elderly population in the world and in our country is gradually increasing and the aging process is prolonged due to the prolongation of life expectancy. Osteoarthritis is one of the important obstacles limiting low quality of life and physical freedom in this aging process. It is estimated that osteoarthritis affects over 250 million people worldwide. Osteoarthritis is one of the important causes of severe pain and disability due to limitation of mobility, and this disease is a disease that causes deterioration in the psychological well-being of individuals and a low quality of life. The presence of symptoms characterized by joint pain, stiffness and limitation of movement in osteoarthritis negatively affects the quality of life of individuals. One of the most common problems in our country is osteoarthritis of the knee. In the treatment of osteoarthritis of the knee, total knee replacement surgery is performed as a last resort if pharmacologic and non-pharmacologic methods do not yield a positive response. Patients with total knee replacement may be exposed to anxiety and pain in this process. In previous studies, positive results were found when the effects of virtual reality application on pain were examined. The aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement. In previous studies, it was determined that virtual reality application was mostly applied preoperatively and examined pain and vital signs. There are no studies on quality of recovery
- Conditions
- Anxiety, Recovery Quality
- Being tested
- pre-op VR application group, intra-op VR application group
- Keywords
- virtual reality, anxiety, recovery quality, total knee replacement, nursing
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-op VR application groupOther
VR application group during preoperative process
intra-op VR application groupOther
VR application group during intraoperative process
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | pre-op VR application group Receives: Other: pre-op VR application group |
| Group 2 | Experimental | Intra-op VR application group Receives: Other: intra-op VR application group |
| Control | No intervention | Standart care and treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Beck Anxiety Scale
Measured: Pre-test before surgery; post-test two hours after surgery
Recovery quality
quality of recovery-15 (QoR-15)
Measured: Pre-test before surgery; post-test two hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start21 Apr 2024
- Primary completion30 Dec 2024
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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 study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Özge İşeri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Özge İşeri, Ondokuz Mayıs University
- Investigators
- Özge İşeri Assistant Professor, PhD, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792123
- Sponsor's protocol ID
- OMUKAEK 2023/423
- Other IDs
- Ondokuz Mayıs University
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Since this is a master thesis, the results will be shared at the end of the thesis
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application Applied to Patients With Total Knee Replacement at Different Times on Anxiety and Recovery Quality
- ClinicalTrials.gov ID
- NCT06792123
- Acronym / sponsor ID
- OMUKAEK 2023/423
- Conditions
- Anxiety, Recovery Quality
- Keywords
- virtual reality, anxiety, recovery quality, total knee replacement, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Özge İşeriUniversity, hospital or other
- Study start
- 21 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 24 Jan 2025 (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 aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement.
Detailed description
The elderly population in the world and in our country is gradually increasing and the aging process is prolonged due to the prolongation of life expectancy. Osteoarthritis is one of the important obstacles limiting low quality of life and physical freedom in this aging process. It is estimated that osteoarthritis affects over 250 million people worldwide. Osteoarthritis is one of the important causes of severe pain and disability due to limitation of mobility, and this disease is a disease that causes deterioration in the psychological well-being of individuals and a low quality of life. The presence of symptoms characterized by joint pain, stiffness and limitation of movement in osteoarthritis negatively affects the quality of life of individuals. One of the most common problems in our country is osteoarthritis of the knee. In the treatment of osteoarthritis of the knee, total knee replacement surgery is performed as a last resort if pharmacologic and non-pharmacologic methods do not yield a positive response. Patients with total knee replacement may be exposed to anxiety and pain in this process. In previous studies, positive results were found when the effects of virtual reality application on pain were examined. The aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement. In previous studies, it was determined that virtual reality application was mostly applied preoperatively and examined pain and vital signs. There are no studies on quality of recovery
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Other: pre-op VR application grouppre-op VR application group |
| Group 2 | Experimental | Other: intra-op VR application groupIntra-op VR application group |
| Control | No intervention | –Standart care and treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over the age of 18
- No psychiatric medication
- No mental and cognitive disabilities
- Those who underwent Total Knee Replacement,
Key exclusion criteria (3 listed)
- Patients with visual and hearing impairment
- Receiving general anesthesia
- Experiencing complications during surgery
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 |
|---|---|---|
| pre-op VR application groupVR application group during preoperative process | Other | group 1 |
| intra-op VR application groupVR application group during intraoperative process | Other | Group 2 |
Primary outcome
Anxiety
Time frame: Pre-test before surgery; post-test two hours after surgery
Beck Anxiety Scale
Recovery quality
Time frame: Pre-test before surgery; post-test two hours after surgery
quality of recovery-15 (QoR-15)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided. Since this is a master thesis, the results will be shared at the end of the thesis
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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.
Özge İşeri Assistant Professor, PhD study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-op VR application group and intra-op VR application group in people with Anxiety and Recovery Quality, run by Özge İşeri 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 11 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Pre-test before surgery; post-test two hours after surgery). 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?
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 May 2026.