An interventional study of Virtual Reality in Total Knee Arthroplasty, sponsored by Manisa Celal Bayar University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Manisa Celal Bayar University · Not applicable, Interventional, and Supportive care
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 1,714 studies in Pain with a site in Turkey — 322 open to participants now, 372 under way, none of them phase 3. Pain · Turkey.
Among the 1,714 studies in Pain with a site in Turkey, this one is the 330th largest by planned enrollment of the 1,491 interventional ones that give a count, is one of 280 that started in 2025, is one of 1,449 with no phase, reaches primary completion later than 342 of the 371 other live ones, and was the 1,331st registered.
10,060 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →322 of the 1,714 studies in Pain with a site in Turkey are open now. Recruiting first, the newest first:
Mersin University · Sites in Turkey
Ages 18+
Artvin Coruh University · Sites in Turkey
Ages 6–12
Mersin University · Sites in Turkey
Ages 18+
Bahçeşehir University · Sites in Turkey
Ages 45–65
Istanbul University · Sites in Turkey
Ages 1–12
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 929 Pain studies recruiting now, 384 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,714 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 6 · Phase 4 34
First in 2006; this study’s year is marked. 280 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 102 is above the median of 66 across 8,497 interventional studies indexed under Pain.
Median enrollment 70 across the 1,491 interventional studies, 84 across the 223 observational. Of the 1,270 that completed or were terminated, 7 (1%) have results posted.
This tab as a report to print or save as PDF → With an account.
4 of 1,714 have an industry lead sponsor. The 10 most frequent:
Manisa Celal Bayar University is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
Manisa Celal Bayar University has 6 studies filed under Pain — fewer than ten, so there is no comparison to draw.
85 of the studies in Pain with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07707726Ankara City Hospital BilkentVirtual Reality in Ingrown Toenail Surgery | 2026-11-15 |
| NCT07846098Cumhuriyet UniversityComparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars | 2026-11-20 |
| NCT07404163Tarsus UniversityWalkway Used in Postoperative Mobilization | 2026-11-30 |
| NCT07915804Istanbul UniversityPerfusion Index for Postoperative Pain Assessment in Pediatric Adenotonsillectomy | 2026-11-30 |
| NCT07892196Antalya Training and Research HospitalDoes Chronic Pain Change Over Time in Children With Duchenne Muscular Dystrophy? | 2026-11-30 |
Add all 85 to your calendar (.ics) → With an account.
Among the 1,714 studies in Pain with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to investigate the effects of virtual reality on pain, anxiety, and comfort during continuous passive motion following total knee arthroplasty
The purpose of this study is to investigate the effects of virtual reality on pain, anxiety, and comfort during continuous passive motion following total knee arthroplasty Study Hypotheses
H0: The use of virtual reality during continuous passive motion following total knee arthroplasty does not reduce pain levels.
H1: The use of virtual reality during continuous passive motion following total knee arthroplasty reduces pain levels.
H0: The use of virtual reality during continuous passive motion following total knee arthroplasty does not reduce anxiety levels.
H1: The use of virtual reality during continuous passive motion following total knee arthroplasty reduces anxiety levels.
H0: The use of virtual reality during continuous passive motion following total knee arthroplasty does not improve comfort levels.
H1: The use of virtual reality during continuous passive motion following total knee arthroplasty improves comfort levels.
Study Population and Sample Size
The study population will consist of patients undergoing total knee arthroplasty at the Orthopedics and Traumatology Department of Manisa Celal Bayar University Hafsa Sultan Hospital between August 2025 and August 2026. The sample size was calculated using G*Power 3.1. Assuming a moderate effect size (d = 0.5) for the differences between intervention and control groups regarding postoperative pain and comfort levels, with 80% power and α = 0.05, the minimum sample size required is 102 patients (n1 = 51, n2 = 51).
Inclusion Criteria
Exclusion Criteria
The study will include 102 patients meeting the eligibility criteria, providing written informed consent, and completing pretests. Patients will be randomized into the virtual reality group or control group using a computer-generated program to ensure allocation concealment and minimize bias (https://www.randomizer.org
). Block randomization will be applied with equal distribution between groups. At the start of the study, opaque sealed envelopes will designate which letter corresponds to each group: A for the virtual reality group and B for the control group. Numbered blocks from the randomization list will be placed in a black bag. Each incoming patient will be assigned to a group based on the block drawn from the bag. The process will continue until all blocks are assigned.
To ensure transparency, completeness, and clarity in reporting, all stages of this randomized controlled trial will follow the CONSORT 2010 guidelines.
Dependent and Independent Variables
Dependent Variables: Patients' state anxiety scores, pain scores, and comfort scores.
Independent Variable: Virtual reality intervention.
Control Variables: Patients' age, gender, education level, occupation, marital status, prior surgical experience, knowledge about virtual reality, and similar demographic and clinical factors.
Data Collection Instruments
The following instruments will be used to collect study data:
Personal Information Form:
A form developed by the researchers to assess patients' age, gender, education level, occupation, marital status, previous surgical experiences, and knowledge about virtual reality.
Visual Analog Scale (VAS):
The VAS is a unidimensional scale widely accepted for assessing acute and chronic pain intensity. It is reliable, simple, and easy to use. The scale ranges from 0 ("no pain") to 10 ("extremely severe pain"). In this study, the VAS will be used to evaluate both pain and comfort levels.
State-Trait Anxiety Inventory (STAI):
The STAI is a self-report questionnaire consisting of short statements, rated on a 4-point Likert scale. It has two subscales: the State Anxiety Scale (STAI-I) and the Trait Anxiety Scale (STAI-II), each containing 20 items.
The state anxiety subscale measures the emotional state experienced by an individual at a specific moment under certain conditions.
The trait anxiety subscale assesses how frequently an individual generally experiences anxiety in daily life.
The scale includes both direct and reverse-scored items. Direct items reflect negative emotions, while reverse-scored items indicate positive emotions. For the state anxiety subscale, reverse-scored items are: 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The total score is calculated by subtracting the sum of reverse-scored items from the sum of direct items and adding a constant value of 29. The fixed constant for the state anxiety subscale is 50. Scores range from 20 to 80, with higher scores indicating higher anxiety.
Pilot Testing To ensure the clarity, feasibility, and usability of the data collection instruments, a pilot study will be conducted with five patients meeting the study criteria and who consent to participate, admitted to the Orthopedics and Traumatology Department of Manisa Celal Bayar University Hafsa Sultan Hospital between September 1-31, 2025. Based on feedback from the pilot, necessary adjustments will be made to the data collection forms. Patients who participate in the pilot study will be excluded from the main study.
Study Procedure
Patients who have undergone total knee arthroplasty (TKA) and are scheduled for continuous passive motion (CPM) on postoperative day 2 will be identified. Eligible patients will be taken to the physiotherapy and rehabilitation room of the Orthopedics and Traumatology Department for CPM. The session for each patient will begin at 10:00 AM. CPM will be performed under the supervision of a physiotherapist, after which patients will be returned to their rooms.
Intervention Group (Virtual Reality Group)
At the start of the study, eligible patients will be informed about the study's purpose and procedures, and verbal and written informed consent will be obtained. Demographic information will be collected via face-to-face interview. Pre-intervention assessments will include:
Pain and comfort levels, measured using the Visual Analog Scale (VAS) Anxiety levels, measured using the State-Trait Anxiety Inventory (STAI) Vital signs, recorded prior to the intervention Patients will be briefed on the use of the virtual reality headset and introduced to the selected video content. During CPM, patients will be positioned in a semi-Fowler position with a pillow under the head for support.
Virtual Reality Device:
Virtual Content:
"Participants will watch a forest walking video along the Middle Fork Snoqualmie River Trail available on YouTube (https://www.youtube.com/watch?v=vlbF9imkUMM-
) with relaxing nature sounds. The video audio will be delivered through fixed headphones on the VR headset. Copyright permission for the video was obtained by subscribing and paying the fee via the website (https://4krelax.com/video/19/896459643/4k-forest-walk-along-middle-fork-snoqualmie-river-trail-hiking-with-relaxing-nature-sounds).
During the Intervention:
Hygiene Protocol:
At the start of the study, patients in the control group will be informed about the study and verbal and written consent will be obtained. Demographic information will be collected via face-to-face interview. Pre-intervention assessments will include:
Pain and comfort levels, measured using the Visual Analog Scale (VAS)
Anxiety levels, measured using the State-Trait Anxiety Inventory (STAI)
Vital signs, recorded prior to the intervention
After the CPM session, vital signs will be re-evaluated, and all pre-intervention scales (VAS, STAI, comfort assessments) will be re-administered.
Patients in the control group will receive routine care only; no additional interventions will be applied.
During the study, all devices used to measure vital signs will be pre-calibrated. Data collection will be performed by the same researcher for all participants to maintain consistency, and no additional observers will be involved. The CPM session and assessments will be repeated on postoperative day 3 following the same procedures.
Data Analysis
Data will be analyzed using SPSS version 25.0 (Statistical Package for the Social Sciences). Descriptive statistics will be presented as frequencies and percentages for categorical variables, and as mean ± standard deviation, median, minimum, and maximum values for continuous variables.
For comparisons between groups:
Categorical variables will be analyzed using Chi-square or Fisher's Exact tests.
Continuous variables with normal distribution will be compared using independent two-sample t-tests for between-group comparisons and paired t-tests for within-group comparisons over two time points.
Non-normally distributed continuous variables will be compared using the Mann-Whitney U test for two-group comparisons.
For comparisons over three or more time points:
Repeated measures ANOVA will be used for normally distributed data. Friedman test will be used for non-normally distributed data. A p-value \< 0.05 will be considered statistically significant.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
First-time total knee arthroplasty Postoperative day 2 Mobilized before CPM application Adequate vision and hearing to use the virtual reality device Oriented to person, place, and time No cognitive, sensory, or verbal communication impairments No history of vertigo No hypertension Not using sedative, anxiolytic, or similar medications Willing to voluntarily participate in the study
Exclusion Criteria:
Virtual Reality
Other: Virtual Reality
The demographic information of the participants will be collected through face-to-face interviews. Pain and comfort levels will be assessed using the Visual Analog Scale (VAS) prior to the intervention. Additionally, anxiety levels will be measured with the Spielberger State-Trait Anxiety Inventory, and vital signs will be recorded. Patients included in the study will be informed about the use of virtual reality (VR) goggles and introduced to the videos that will be viewed. During the Continuous Passive Motion (CPM) application, patients will be positioned in a semi-Fowler's position with a pillow placed under the head for support. Through virtual reality, patients will watch the video Forest Walk along the Middle Fork Snoqualmie River Trail with Relaxing Sounds and the accompanying sounds will be delivered through headphones integrated into the goggles.
Pain, Anxiety, and Comfort Levels during Continuous Passive Motion
Pain and comfort levels will be assessed using the Visual Analog Scale (VAS, 0-10), where 0 indicates no pain/comfort and 10 indicates worst pain/maximal comfort. Anxiety will be measured using the State-Trait Anxiety Inventory (STAI). The effects of virtual reality during CPM on pain, anxiety, and comfort will be compared between the VR and control groups.
Time frame: Immediately before and after each CPM session on postoperative day 2 and day 3
Plan to share: No
Started Sep 2025 (actual). Primary completion is estimated for May 2027, 20 months after the start.
Of 3,734 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 20 months is above that.
Counting every sponsor, half of 3,833 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 22, 2026: primary completion Oct 2026 → May 2027 and completion Oct 2026 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Manisa Celal Bayar University