Knee ReplacementNCT06933732
Effect of Virtual Reality on Patient Outcomes and Satisfaction in Total Knee Replacement
A study testing Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours), Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours) and Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours) in people with Knee Replacement and Knee Replacement Surgery, run by Aykut Turgut at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. Investigators will assess the impact of preoperative VR training on anxiety levels, explore the effectiveness of relaxing and distracting VR… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Replacement, Knee Replacement Surgery, Postoperative Pain, Acute
- What is being tested?
- Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours), Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours) and Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Dec 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an ASA score of 1, 2, or 3
- Elective unilateral total knee replacement surgery was planned,
- Patients who are able to read and write in Turkish
Who cannot join
- Using >30 mg of oral oxycodone or equivalent daily
- Long-term opioid use (>12 weeks)
- Substance use disorder
- Scheduled for emergency surgery
- Scheduled for revision surgery
- Requiring postoperative intensive care
Show all 11Show fewer
- Patients with visual or hearing impairments
- Individuals experiencing motion-related nausea or dizziness
- History of stroke or dementia
- Pregnant or breastfeeding women
- Patients with a history of epilepsy or seizures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Aibu Izzet Baysal Training and Research Hospital
Bolu, 14280
Aykut Turgut, MSc, +905432599683, turgut_aykut@yahoo.com
turgut_aykut@yahoo.com
About this study
Official title: The Effect of Virtual Reality Applications on Patient Outcomes and Satisfaction Before and After Total Knee Replacement: A Randomised Controlled Study
This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. Investigators will assess the impact of preoperative VR training on anxiety levels, explore the effectiveness of relaxing and distracting VR videos for pain management after surgery, and determine the optimal timing for VR application by comparing different VR intervention times. Our goal is to identify how VR can improve both the emotional and physical recovery process for patients undergoing knee replacement surgery.
- Conditions
- Knee Replacement, Knee Replacement Surgery, Postoperative Pain, Acute, Anxiety, Preoperative, Pain Management, Virtual Reality
- Being tested
- Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours), Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours), Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours)
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours)Device
The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 2 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time.
Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours)Device
The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 4 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time.
Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours)Device
The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 6 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants in this group will receive standard care, which includes preoperative education about the surgical process via an educational video and the completion of informed consent. No virtual reality intervention will be provided during their recovery. |
| 2-Hour Postoperative VR Intervention | Experimental | Participants in this group will first watch an educational VR video about the surgery before the procedure. Two hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos. Receives: Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours) |
| 4-Hour Postoperative VR Intervention | Experimental | Participants in this group will first watch an educational VR video about the surgery before the procedure. Four hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos. Receives: Device: Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours) |
| 6-Hour Postoperative VR Intervention | Experimental | Participants in this group will first watch an educational VR video about the surgery before the procedure. Six hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos. Receives: Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Postoperative Pain Intensity as Measured by Visual Analogue Scale (VAS) at 2, 4, and 6 Hours After Surgery in Patients Receiving Virtual Reality Interventions.
0 = No pain 10 = Worst pain possible
Measured: Baseline (before VR intervention) and assessments at 2, 4, and 6 hours after surgery, with a 15-Minute wait after VR video completion before each pain assessment
Secondary outcomes (8)
Preoperative Anxiety Measured Using the State-Trait Anxiety Inventory-State (STAI-S) Scale
Preoperative anxiety will be measured using the State-Trait Anxiety Inventory-State (STAI-S) scale, which is a validated tool for assessing temporary feelings of anxiety. Patients will complete the scale before undergoing any intervention or VR exposure. This measurement will provide an understanding of the patient's baseline anxiety level before the application of VR. This measurement will be taken twice: once before the patients view the educational videos and once after viewing them.
Total scores range from 20 to 80. Higher scores = Higher levels of anxiety.
Measured: Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)
Change from Baseline in Virtual Reality Sickness as Measured by the Virtual Reality Sickness Questionnaire (VRSQ)
The Virtual Reality Sickness Questionnaire (VRSQ) assesses the level of discomfort or sickness experienced by participants during or immediately after wearing the Virtual Reality headset.
Total scores range from 0 to 15, with higher scores indicating higher levels of discomfort or sickness.
Measured: Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)
Patient Satisfaction as Measured by a 0-10 Numeric Rating Scale Post-Intervention
Patient satisfaction will be measured using a 0-10 Numeric Rating Scale (NRS), where 0 represents no satisfaction and 10 represents the highest level of satisfaction.
Measured: Postoperative, Day 1
Change in Body Temperature (Celsius) from Baseline
Measured: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Heart Rate/min from Baseline
Measured: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Blood Pressure from Baseline (Systolic/Diastolic mmHg)
Measured: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Respiratory Rate/min from Baseline
Measured: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Blood Oxygen Saturation(%) from Baseline
Measured: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start25 Dec 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ReplacementStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aykut Turgut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aykut Turgut, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933732
- Sponsor's protocol ID
- AIBU-SBF-AT-02
- Status last verified
- Sep 2025
- First submitted
- 2 Mar 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not planned to be shared at this time, as it is considered important to first publish the data in the form of a manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Applications on Patient Outcomes and Satisfaction Before and After Total Knee Replacement: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT06933732
- Acronym / sponsor ID
- AIBU-SBF-AT-02
- Conditions
- Knee Replacement, Knee Replacement Surgery, Postoperative Pain, Acute, Anxiety, Preoperative, Pain Management, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Aykut TurgutUniversity, hospital or other
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 18 Apr 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.
This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. Investigators will assess the impact of preoperative VR training on anxiety levels, explore the effectiveness of relaxing and distracting VR videos for pain management after surgery, and determine the optimal timing for VR application by comparing different VR intervention times. Our goal is to identify how VR can improve both the emotional and physical recovery process for patients undergoing knee replacement surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants in this group will receive standard care, which includes preoperative education about the surgical process via an educational video and the completion of informed consent. No virtual reality intervention will be provided during their recovery. |
| 2-Hour Postoperative VR Intervention | Experimental | Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours)Participants in this group will first watch an educational VR video about the surgery before the procedure. Two hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos. |
| 4-Hour Postoperative VR Intervention | Experimental | Device: Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours)Participants in this group will first watch an educational VR video about the surgery before the procedure. Four hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos. |
| 6-Hour Postoperative VR Intervention | Experimental | Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours)Participants in this group will first watch an educational VR video about the surgery before the procedure. Six hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an ASA score of 1, 2, or 3
- Elective unilateral total knee replacement surgery was planned,
- Patients who are able to read and write in Turkish
Key exclusion criteria (11 listed)
- Using >30 mg of oral oxycodone or equivalent daily
- Long-term opioid use (>12 weeks)
- Substance use disorder
- Scheduled for emergency surgery
- Scheduled for revision 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 |
|---|---|---|
| Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours)The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 2 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time. | Device | 2-Hour Postoperative VR Intervention |
| Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours)The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 4 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time. | Device | 4-Hour Postoperative VR Intervention |
| Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours)The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 6 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time. | Device | 6-Hour Postoperative VR Intervention |
Primary outcome
Change from Baseline in Postoperative Pain Intensity as Measured by Visual Analogue Scale (VAS) at 2, 4, and 6 Hours After Surgery in Patients Receiving Virtual Reality Interventions.
Time frame: Baseline (before VR intervention) and assessments at 2, 4, and 6 hours after surgery, with a 15-Minute wait after VR video completion before each pain assessment
0 = No pain 10 = Worst pain possible
8 secondary outcomes
Preoperative Anxiety Measured Using the State-Trait Anxiety Inventory-State (STAI-S) Scale
Time frame: Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)
Change from Baseline in Virtual Reality Sickness as Measured by the Virtual Reality Sickness Questionnaire (VRSQ)
Time frame: Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)
Patient Satisfaction as Measured by a 0-10 Numeric Rating Scale Post-Intervention
Time frame: Postoperative, Day 1
Change in Body Temperature (Celsius) from Baseline
Time frame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Heart Rate/min from Baseline
Time frame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Blood Pressure from Baseline (Systolic/Diastolic mmHg)
Time frame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Respiratory Rate/min from Baseline
Time frame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Blood Oxygen Saturation(%) from Baseline
Time frame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No. IPD is not planned to be shared at this time, as it is considered important to first publish the data in the form of a manuscript.
Related trials for Knee Replacement
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
Recruiting
SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty
Knee Osteoarthritis
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty
Knee Osteoarthritis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
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.
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 Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours), Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours) and Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours) in people with Knee Replacement and Knee Replacement Surgery, run by Aykut Turgut 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 11 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: opening soon, as of the sponsor's last update on 26 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aykut Turgut, MSc (+905432599683, turgut_aykut@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Postoperative Pain Intensity as Measured by Visual Analogue Scale (VAS) at 2, 4, and 6 Hours After Surgery in Patients Receiving Virtual Reality Interventions. (time frame: Baseline (before VR intervention) and assessments at 2, 4, and 6 hours after surgery, with a 15-Minute wait after VR video completion before each pain assessment). 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 26 Sep 2025.