- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07545447
Effect of AI-Assisted Anatomical Visualization on Anxiety and Kinesiophobia in Knee Arthroplasty Patients (AI-KNEE)
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.
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Clinical Education
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.
|
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.
|
|
Active Comparator: Video-Supported Education
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.
|
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.
|
|
Experimental: AI-Assisted Anatomical Visualization Training
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
postoperative day 1, discharge day ( postoperative day 3-4) and postoperative day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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.
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIKNEE-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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