AzTrials
AzTrials

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).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

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
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

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.

Nilgun SOYLEMEZ, PhD contact

+905439790424

nilgunsoylemez@munzur.edu.tr

Derya Öztürk Soylemez, PhD contact

+905446952000

deryaozturk@sinop.edu.tr

Turkey (Türkiye)1 site, 1 recruiting
  • Elazığ Fethi Sekin City Hospital

    Elâzığ, Ulukent, 23000

    Nilgun SOYLEMEZ, PhD, +905439790424, nilgunsoylemez@munzur.edu.tr

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07545447
Study groupRoleWhat they receive
Standard Clinical EducationActive comparatorParticipants 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 EducationActive comparatorParticipants 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 TrainingExperimentalParticipants 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.

  1. 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)
  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.

  1. First posted22 Apr 2026
  2. Study start15 Aug 2026
  3. Primary completion15 Apr 2027 (estimated)
  4. Study completion15 Jun 2027 (estimated)

Resources

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)
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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in