Knee OsteoarthritisAI-KNEENCT07545447
Effect of AI-Assisted Anatomical Visualization on Anxiety and Kinesiophobia in Knee Arthroplasty Patients
A study testing Standard Clinical Education, Video-Supported Education and AI-Assisted Anatomical Visualization Training in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Munzur University at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TDA) is an effective surgical method applied to reduce pain, improve joint function, and enhance quality of life in patients with advanced osteoarthritis or joint degeneration. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty
- What is being tested?
- Standard Clinical Education, Video-Supported Education and AI-Assisted Anatomical Visualization Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Jun 2027
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 55 years and older
- Patients scheduled for elective total knee arthroplasty due to knee osteoarthritis
- Able to understand and communicate in Turkish
- Willing to participate in the study and provide written informed consent
- No prior total knee arthroplasty on the study knee
- Cognitively able to complete questionnaires and follow study procedures
Who cannot join
- Patients scheduled for revision total knee arthroplasty
- Patients with active infection
- Presence of severe neurological or psychiatric disease (conditions that would prevent reliable application of scales)
- Severe visual or hearing loss
- Diagnosed dementia or cognitive impairment
- Individuals who refused to participate in the study
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, 1 recruiting
- Recruiting
Elazığ Fethi Sekin City Hospital
Elâzığ, Ulukent, 23000
Nilgun SOYLEMEZ, PhD, +905439790424, nilgunsoylemez@munzur.edu.tr
About this study
Official title: The Effect of AI-Assisted Anatomical Visualization Training on Anxiety and Kinesiophobia in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Study
Total knee arthroplasty (TDA) is an effective surgical method applied to reduce pain, improve joint function, and enhance quality of life in patients with advanced osteoarthritis or joint degeneration. However, it is known that surgical success is not limited to the operation itself; pre- and post-operative processes are at least as important as the surgical technique. In particular, active patient participation, early mobilization, and adherence to exercises during the rehabilitation period directly affect treatment outcomes.
Patient education plays a critical role in this process. Accurate and sufficient information reduces patients' anxieties about the surgical process and increases their confidence in the recovery process. It also prevents the development of kinesiophobia (fear of movement), supporting patients in participating in physical activity more quickly and safely.
Read more
Patient education can be provided through various methods. Traditional approaches include face-to-face clinical training, verbal information provided by nurses or physiotherapists, written brochures, and visual materials. While this standard clinical training is effective in conveying basic information, it may have limitations in patients' ability to recall information and adapt it to daily life.
In recent years, technology-based training methods have gained increasing importance. In particular, AI-assisted video-based anatomical visualization training can present the structure of the surgery, the placement of the prosthesis, and the movement mechanism to patients in a more understandable and visual way. Such interactive and visually rich training offers advantages in terms of increasing patients' knowledge levels, reducing anxiety, and strengthening their participation in treatment.
In conclusion, success after total knee arthroplasty depends not only on the surgical intervention but also on effective patient education. Comparing standard clinical training with AI-assisted visual training methods constitutes an important area of research for improving patient outcomes.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the effects of different patient education methods on anxiety and kinesiophobia in patients undergoing total knee arthroplasty. The study will be conducted with adult patients scheduled for elective total knee arthroplasty surgery.
Participants will be randomly assigned into three groups. The first group will receive standard clinical education, which includes routine preoperative and postoperative verbal information, written educational materials, and conventional nursing or physiotherapy counseling. The second group will receive video-supported education in addition to standard clinical education, using structured educational videos to enhance understanding of the surgical and rehabilitation process. The third group will receive AI-assisted anatomical visualization training, which includes interactive video content enhanced with artificial intelligence-based anatomical modeling to improve visualization of the joint structure, prosthesis placement, and functional recovery.
All interventions will be delivered in the preoperative period. Standard care will continue for all groups as part of routine clinical practice.
Primary outcomes are anxiety and kinesiophobia levels, which will be assessed using validated measurement scales at baseline and during postoperative follow-up. Secondary outcomes may include patient satisfaction with education and adherence to rehabilitation exercises.
The aim of the study is to compare the effectiveness of standard education, video-supported education, and AI-assisted anatomical visualization training in reducing psychological barriers and improving recovery outcomes after total knee arthroplasty.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Being tested
- Standard Clinical Education, Video-Supported Education, AI-Assisted Anatomical Visualization Training
- Keywords
- Total Knee Arthroplasty, AI-Assisted Training, Anxiety, Kinesiophobia
- Medical subject headings
- Osteoarthritis, Knee, Anxiety Disorders, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Clinical EducationBehavioural
Participants receive routine preoperative and postoperative education including verbal counseling by healthcare professionals, written informational materials, and standard physiotherapy guidance regarding total knee arthroplasty and rehabilitation exercises.
Video-Supported EducationBehavioural
Participants receive standard clinical education combined with structured educational videos demonstrating total knee arthroplasty procedure, prosthesis function, and rehabilitation exercises to improve patient understanding and information retention.
AI-Assisted Anatomical Visualization TrainingBehavioural
Participants receive standard clinical education in addition to AI-assisted anatomical visualization training using interactive video-based content. This intervention provides enhanced visualization of knee joint anatomy, prosthesis placement, and postoperative functional movement to improve understanding and reduce anxiety and kinesiophobia.
| Study group | Role | What they receive |
|---|---|---|
| Standard Clinical Education | Active comparator | Participants in this arm will receive standard clinical education as part of routine care. This includes face-to-face verbal education provided by healthcare professionals, written informational materials, and conventional preoperative and postoperative counseling regarding total knee arthroplasty and rehabilitation exercises. Receives: Behavioral: Standard Clinical Education |
| Video-Supported Education | Active comparator | Participants in this arm will receive standard clinical education combined with structured video-supported educational content. The videos will demonstrate the surgical procedure, prosthesis function, and postoperative rehabilitation exercises in a visual format to enhance understanding and retention of information. Receives: Behavioral: Video-Supported Education |
| AI-Assisted Anatomical Visualization Training | Experimental | Participants in this arm will receive standard clinical education in addition to AI-assisted anatomical visualization training. This intervention uses artificial intelligence-supported interactive video content to provide enhanced anatomical visualization of the knee joint, prosthesis placement, and functional movement. The aim is to improve patient understanding, reduce anxiety, and decrease kinesiophobia related to total knee arthroplasty. Receives: Behavioral: AI-Assisted Anatomical Visualization Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level
State Anxiety - (STAI-I): The State-Trait Anxiety Inventory (STAI), developed by Spielberger and adapted into Turkish by Öner and Le Compte, will be used to assess anxiety levels. The STAI consists of 40 items and two subscales: State Anxiety and Trait Anxiety. In this study, the State Anxiety subscale will be used to measure participants' current anxiety levels.
The State Anxiety subscale is a 4-point Likert-type scale ranging from 1 (not at all) to 4 (completely). Higher scores indicate higher levels of anxiety. The scale includes both positively and negatively worded items, which are reverse-scored accordingly. A constant value of 50 is added to the total score to obtain the final score.
Measured: postoperative day 1, discharge day ( postoperative day 3-4) and postoperative day 14
Secondary outcomes (1)
Kinesiophobia Level
The Tampa Kinesiophobi Scale (TKS): The TKS is a test that measures the fear of movement/re-injury. The scale was developed by Miller, Kopri, and Todd, but was never published. Vlaeyen et al., with the permission of the original researchers, republished the original scale, consisting of 17 questions, in 1995. The Turkish version and its reliability were determined by Yılmaz and the test-retest reliability was found to be 0.81. The scale uses a 4-point Likert scale (1 = Strongly disagree, 4 = Strongly agree), with a total score ranging from 17 to 68. It is recommended to use the total score in studies. A higher score on the scale indicates a higher fear of movement.
Measured: Kinesiophobia will be evaluated using a validated kinesiophobia scale at three time points: postoperative day 1, discharge day ( postoperative day 3-4) and postoperative day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start15 Aug 2026
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a three-arm parallel-group randomized controlled trial. Participants will be randomly assigned to one of three groups: standard clinical education, video-supported education, or AI-assisted anatomical visualization training. Each group will receive its assigned intervention independently, without crossover between groups. Outcomes will be compared between groups to evaluate the effectiveness of different educational approaches on anxiety and kinesiophobia in patients undergoing total knee arthroplasty.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Munzur University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgün SÖYLEMEZ, Munzur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545447
- Sponsor's protocol ID
- AIKNEE-2026-01
- Acronym
- AI-KNEE
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of AI-Assisted Anatomical Visualization Training on Anxiety and Kinesiophobia in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07545447
- Acronym / sponsor ID
- AI-KNEE / AIKNEE-2026-01
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, AI-Assisted Training, Anxiety, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Munzur UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
Total knee arthroplasty (TDA) is an effective surgical method applied to reduce pain, improve joint function, and enhance quality of life in patients with advanced osteoarthritis or joint degeneration. However, it is known that surgical success is not limited to the operation itself; pre- and post-operative processes are at least as important as the surgical technique. In particular, active patient participation, early mobilization, and adherence to exercises during the rehabilitation period directly affect treatment outcomes.
Patient education plays a critical role in this process. Accurate and sufficient information reduces patients' anxieties about the surgical process and increases their confidence in the recovery process. It also prevents the development of kinesiophobia (fear of movement), supporting patients in participating in physical activity more quickly and safely.
Patient education can be provided through various methods. Traditional approaches include face-to-face clinical training, verbal information provided by nurses or physiotherapists, written brochures, and visual materials. While this standard clinical training is effective in conveying basic information, it may have limitations in patients' ability to recall information and adapt it to daily life.
In recent years, technology-based training methods have gained increasing importance. In particular, AI-assisted video-based anatomical visualization training can present the structure of the surgery, the placement of the prosthesis, and the movement mechanism to patients in a more understandable and visual way. Such interactive and visually rich training offers advantages in terms of increasing patients' knowledge levels, reducing anxiety, and strengthening their participation in treatment.
In conclusion, success after total knee arthroplasty depends not only on the surgical intervention but also on effective patient education. Comparing standard clinical training with AI-assisted visual training methods constitutes an important area of research for improving patient outcomes.
Detailed description
This study is a randomized controlled trial designed to evaluate the effects of different patient education methods on anxiety and kinesiophobia in patients undergoing total knee arthroplasty. The study will be conducted with adult patients scheduled for elective total knee arthroplasty surgery.
Participants will be randomly assigned into three groups. The first group will receive standard clinical education, which includes routine preoperative and postoperative verbal information, written educational materials, and conventional nursing or physiotherapy counseling. The second group will receive video-supported education in addition to standard clinical education, using structured educational videos to enhance understanding of the surgical and rehabilitation process. The third group will receive AI-assisted anatomical visualization training, which includes interactive video content enhanced with artificial intelligence-based anatomical modeling to improve visualization of the joint structure, prosthesis placement, and functional recovery.
All interventions will be delivered in the preoperative period. Standard care will continue for all groups as part of routine clinical practice.
Primary outcomes are anxiety and kinesiophobia levels, which will be assessed using validated measurement scales at baseline and during postoperative follow-up. Secondary outcomes may include patient satisfaction with education and adherence to rehabilitation exercises.
The aim of the study is to compare the effectiveness of standard education, video-supported education, and AI-assisted anatomical visualization training in reducing psychological barriers and improving recovery outcomes after total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study is designed as a three-arm parallel-group randomized controlled trial. Participants will be randomly assigned to one of three groups: standard clinical education, video-supported education, or AI-assisted anatomical visualization training. Each group will receive its assigned intervention independently, without crossover between groups. Outcomes will be compared between groups to evaluate the effectiveness of different educational approaches on anxiety and kinesiophobia in patients undergoing total knee arthroplasty.
| Arm | Type | Receives |
|---|---|---|
| Standard Clinical Education | Active comparator | Behavioral: Standard Clinical EducationParticipants in this arm will receive standard clinical education as part of routine care. This includes face-to-face verbal education provided by healthcare professionals, written informational materials, and conventional preoperative and postoperative counseling regarding total knee arthroplasty and rehabilitation exercises. |
| Video-Supported Education | Active comparator | Behavioral: Video-Supported EducationParticipants in this arm will receive standard clinical education combined with structured video-supported educational content. The videos will demonstrate the surgical procedure, prosthesis function, and postoperative rehabilitation exercises in a visual format to enhance understanding and retention of information. |
| AI-Assisted Anatomical Visualization Training | Experimental | Behavioral: AI-Assisted Anatomical Visualization TrainingParticipants in this arm will receive standard clinical education in addition to AI-assisted anatomical visualization training. This intervention uses artificial intelligence-supported interactive video content to provide enhanced anatomical visualization of the knee joint, prosthesis placement, and functional movement. The aim is to improve patient understanding, reduce anxiety, and decrease kinesiophobia related to total knee arthroplasty. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 55 years and older
- Patients scheduled for elective total knee arthroplasty due to knee osteoarthritis
- Able to understand and communicate in Turkish
- Willing to participate in the study and provide written informed consent
- No prior total knee arthroplasty on the study knee
Key exclusion criteria (6 listed)
- Patients scheduled for revision total knee arthroplasty
- Patients with active infection
- Presence of severe neurological or psychiatric disease (conditions that would prevent reliable application of scales)
- Severe visual or hearing loss
- Diagnosed dementia or cognitive impairment
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 |
|---|---|---|
| Standard Clinical EducationParticipants receive routine preoperative and postoperative education including verbal counseling by healthcare professionals, written informational materials, and standard physiotherapy guidance regarding total knee arthroplasty and rehabilitation exercises. | Behavioural | Standard Clinical Education |
| Video-Supported EducationParticipants receive standard clinical education combined with structured educational videos demonstrating total knee arthroplasty procedure, prosthesis function, and rehabilitation exercises to improve patient understanding and information retention. | Behavioural | Video-Supported Education |
| AI-Assisted Anatomical Visualization TrainingParticipants receive standard clinical education in addition to AI-assisted anatomical visualization training using interactive video-based content. This intervention provides enhanced visualization of knee joint anatomy, prosthesis placement, and postoperative functional movement to improve understanding and reduce anxiety and kinesiophobia. | Behavioural | AI-Assisted Anatomical Visualization Training |
Primary outcome
Anxiety Level
Time frame: postoperative day 1, discharge day ( postoperative day 3-4) and postoperative day 14
State Anxiety - (STAI-I): The State-Trait Anxiety Inventory (STAI), developed by Spielberger and adapted into Turkish by Öner and Le Compte, will be used to assess anxiety levels. The STAI consists of 40 items and two subscales: State Anxiety and Trait Anxiety. In this study, the State Anxiety subscale will be used to measure participants' current anxiety levels. The State Anxiety subscale is a 4-point Likert-type scale ranging from 1 (not at all) to 4 (completely). Higher scores indicate higher levels of anxiety. The scale includes both positively and negatively worded items, which are reverse-scored accordingly. A constant value of 50 is added to the total score to obtain the final score.
1 secondary outcome
Kinesiophobia Level
Time frame: Kinesiophobia will be evaluated using a validated kinesiophobia scale at three time points: postoperative day 1, discharge day ( postoperative day 3-4) and postoperative day 14
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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Clinical Education, Video-Supported Education and AI-Assisted Anatomical Visualization Training in people with Knee Osteoarthritis and Total Knee Arthroplasty, run by Munzur University 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Oct 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?
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 Nilgun SOYLEMEZ, PhD (+905439790424, nilgunsoylemez@munzur.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level (time frame: postoperative day 1, discharge day ( postoperative day 3-4) and postoperative day 14). 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 14 Oct 2026.