Total Knee ArthroplastyNCT07310303
Simulation-Based Preoperative Education in Total Knee Arthroplasty
A study testing Simulation-Based Preoperative Education, Standard Verbal Preoperative Education and Total Knee Arthroplasty in people with Total Knee Arthroplasty and Surgical Fear and Worrying, run by Nermin Ocaktan at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of simulation-based preoperative education on surgical fear and kinesiophobia in patients undergoing total knee arthroplasty. Eligible patients are randomly assigned to either a simulation-based education group or a standard verbal education (control) group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Surgical Fear and Worrying, Kinesiophobia
- What is being tested?
- Simulation-Based Preoperative Education, Standard Verbal Preoperative Education and Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years and older
- Scheduled for primary total knee arthroplasty
- Able to communicate and cooperate
- Able to speak and understand Turkish
- No diagnosed major psychiatric disorder
- No diagnosed neurological disorder
- Willing to participate and able to provide written informed consent
Who cannot join
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Total knee arthroplasty performed due to trauma
- Presence of neurological, traumatic, or systemic conditions that may limit mobility
- Development of postoperative surgical or prosthesis-related complications
- Development of any condition preventing postoperative mobilization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Mehmet Ali Aydinlar University
Istanbul, Istanbul, 34752
About this study
Official title: The Effect of Simulation-Based Preoperative Education on Surgical Fear and Kinesiophobia in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of simulation-based preoperative education on surgical fear and kinesiophobia in patients undergoing total knee arthroplasty. Eligible patients are randomly assigned to either a simulation-based education group or a standard verbal education (control) group. Surgical fear, kinesiophobia, and postoperative pain are assessed using validated measurement tools. The findings of this study are expected to contribute to evidence-based nursing practices by informing the development of effective preoperative education strategies to improve postoperative recovery outcomes.
Read the detailed description
Total knee arthroplasty is a major orthopedic surgical procedure that may lead to significant physical and psychological challenges for patients during the perioperative period. In addition to postoperative pain and functional limitations, patients frequently experience surgical fear and fear of movement (kinesiophobia), which may negatively affect early mobilization and recovery. Preoperative education is considered an essential nursing intervention to support patients in coping with these challenges; however, the optimal method for delivering such education remains an area of ongoing research.
Simulation-based education has increasingly been used in healthcare education to enhance understanding, reduce uncertainty, and improve preparedness by allowing individuals to actively engage with the anticipated care process. While its effectiveness has been well documented in student education, evidence regarding its use in preoperative patient education, particularly in orthopedic surgery, is limited.
This randomized controlled trial aims to examine the effect of simulation-based preoperative education on surgical fear and kinesiophobia in patients undergoing primary total knee arthroplasty. Eligible patients are randomly assigned to either an intervention group receiving simulation-based preoperative education or a control group receiving standard verbal preoperative education according to institutional routine practice. The educational intervention is delivered one day prior to surgery.
Data are collected using validated instruments, including the Surgical Fear Questionnaire, the Tampa Scale of Kinesiophobia, and the Visual Analog Scale for pain assessment. Surgical fear is assessed during the preoperative period, while kinesiophobia and postoperative pain are evaluated following surgery during the early mobilization phase.
The results of this study are expected to provide evidence to inform nursing-led preoperative education strategies and to support the development of patient-centered approaches aimed at improving psychological preparedness and postoperative recovery in individuals undergoing total knee arthroplasty.
- Being tested
- Simulation-Based Preoperative Education, Standard Verbal Preoperative Education, Total Knee Arthroplasty
- Keywords
- Total Knee Arthroplasty, Simulation-Based Education, Preoperative Education, Surgical Fear, Kinesiophobia, Nursing Intervention, Randomized Controlled Trial
- Medical subject headings
- Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based Preoperative EducationOther
Simulation-based education provided preoperatively to prepare patients for postoperative mobilization and recovery.
Standard Verbal Preoperative EducationOther
Routine verbal preoperative education provided according to institutional standards.
Total Knee ArthroplastyProcedure or surgery
All participants in both study arms undergo standard total knee arthroplasty performed according to institutional clinical protocols.
| Study group | Role | What they receive |
|---|---|---|
| Simulation-Based Preoperative Education | Experimental | Participants receive simulation-based preoperative education focusing on postoperative mobilization and recovery one day before surgery. Receives: Other: Simulation-Based Preoperative Education; Procedure: Total Knee Arthroplasty |
| Standard Verbal Preoperative Education | Active comparator | Participants receive routine standard verbal preoperative education according to institutional practice. Receives: Other: Standard Verbal Preoperative Education; Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Fear
Surgical fear will be assessed using the Surgical Fear Questionnaire, a validated self-report instrument measuring short-term and long-term fear related to surgery. Surgical fear will be assessed using the Surgical Fear Questionnaire, a validated self-report instrument measuring short-term and long-term fear related to surgery. Scores range from 0 to 80, with higher scores indicating greater levels of surgical fear.
Measured: Preoperative period (one day before surgery)
Secondary outcomes (2)
Kinesiophobia
Kinesiophobia will be measured using the Tampa Scale of Kinesiophobia, a validated self-report scale assessing fear of movement and re-injury. Scores range from 17 to 68, with higher scores indicating greater levels of kinesiophobia.
Measured: Postoperative period after recovery of cognitive function
Postoperative Pain Intensity
Postoperative pain intensity will be assessed using the Visual Analog Scale (VAS). Scores range from 0 to 10, with higher scores indicating greater pain intensity.
Measured: Early postoperative period during first mobilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start15 Jan 2025
- Primary completion30 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Model description
- Participants are randomly assigned to either a simulation-based preoperative education group or a standard verbal education control group, with parallel comparison of outcomes between groups.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nermin Ocaktan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nermin Ocaktan, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310303
- Sponsor's protocol ID
- 2024-18-688
- Status last verified
- May 2026
- First submitted
- 16 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves a small sample size and includes sensitive patient-reported psychological measures. Data sharing was not included in the informed consent process, and access to the dataset is restricted in accordance with institutional and ethical regulations.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-Based Preoperative Education on Surgical Fear and Kinesiophobia in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07310303
- Acronym / sponsor ID
- 2024-18-688
- Keywords
- Total Knee Arthroplasty, Simulation-Based Education, Preoperative Education, Surgical Fear, Kinesiophobia, Nursing Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Nermin OcaktanUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 30 Dec 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 randomized controlled trial aims to evaluate the effect of simulation-based preoperative education on surgical fear and kinesiophobia in patients undergoing total knee arthroplasty. Eligible patients are randomly assigned to either a simulation-based education group or a standard verbal education (control) group. Surgical fear, kinesiophobia, and postoperative pain are assessed using validated measurement tools. The findings of this study are expected to contribute to evidence-based nursing practices by informing the development of effective preoperative education strategies to improve postoperative recovery outcomes.
Detailed description
Total knee arthroplasty is a major orthopedic surgical procedure that may lead to significant physical and psychological challenges for patients during the perioperative period. In addition to postoperative pain and functional limitations, patients frequently experience surgical fear and fear of movement (kinesiophobia), which may negatively affect early mobilization and recovery. Preoperative education is considered an essential nursing intervention to support patients in coping with these challenges; however, the optimal method for delivering such education remains an area of ongoing research.
Simulation-based education has increasingly been used in healthcare education to enhance understanding, reduce uncertainty, and improve preparedness by allowing individuals to actively engage with the anticipated care process. While its effectiveness has been well documented in student education, evidence regarding its use in preoperative patient education, particularly in orthopedic surgery, is limited.
This randomized controlled trial aims to examine the effect of simulation-based preoperative education on surgical fear and kinesiophobia in patients undergoing primary total knee arthroplasty. Eligible patients are randomly assigned to either an intervention group receiving simulation-based preoperative education or a control group receiving standard verbal preoperative education according to institutional routine practice. The educational intervention is delivered one day prior to surgery.
Data are collected using validated instruments, including the Surgical Fear Questionnaire, the Tampa Scale of Kinesiophobia, and the Visual Analog Scale for pain assessment. Surgical fear is assessed during the preoperative period, while kinesiophobia and postoperative pain are evaluated following surgery during the early mobilization phase.
The results of this study are expected to provide evidence to inform nursing-led preoperative education strategies and to support the development of patient-centered approaches aimed at improving psychological preparedness and postoperative recovery in individuals undergoing total knee arthroplasty.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either a simulation-based preoperative education group or a standard verbal education control group, with parallel comparison of outcomes between groups.
| Arm | Type | Receives |
|---|---|---|
| Simulation-Based Preoperative Education | Experimental | Other: Simulation-Based Preoperative Education, Procedure: Total Knee ArthroplastyParticipants receive simulation-based preoperative education focusing on postoperative mobilization and recovery one day before surgery. |
| Standard Verbal Preoperative Education | Active comparator | Other: Standard Verbal Preoperative Education, Procedure: Total Knee ArthroplastyParticipants receive routine standard verbal preoperative education according to institutional practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 years and older
- Scheduled for primary total knee arthroplasty
- Able to communicate and cooperate
- Able to speak and understand Turkish
- No diagnosed major psychiatric disorder
Key exclusion criteria (6 listed)
- Revision total knee arthroplasty
- Bilateral total knee arthroplasty
- Total knee arthroplasty performed due to trauma
- Presence of neurological, traumatic, or systemic conditions that may limit mobility
- Development of postoperative surgical or prosthesis-related complications
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 |
|---|---|---|
| Simulation-Based Preoperative EducationSimulation-based education provided preoperatively to prepare patients for postoperative mobilization and recovery. | Other | Simulation-Based Preoperative Education |
| Standard Verbal Preoperative EducationRoutine verbal preoperative education provided according to institutional standards. | Other | Standard Verbal Preoperative Education |
| Total Knee ArthroplastyAll participants in both study arms undergo standard total knee arthroplasty performed according to institutional clinical protocols. | Procedure or surgery | Simulation-Based Preoperative Education, Standard Verbal Preoperative Education |
Primary outcome
Surgical Fear
Time frame: Preoperative period (one day before surgery)
Surgical fear will be assessed using the Surgical Fear Questionnaire, a validated self-report instrument measuring short-term and long-term fear related to surgery. Surgical fear will be assessed using the Surgical Fear Questionnaire, a validated self-report instrument measuring short-term and long-term fear related to surgery. Scores range from 0 to 80, with higher scores indicating greater levels of surgical fear.
2 secondary outcomes
Kinesiophobia
Time frame: Postoperative period after recovery of cognitive function
Postoperative Pain Intensity
Time frame: Early postoperative period during first mobilization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves a small sample size and includes sensitive patient-reported psychological measures. Data sharing was not included in the informed consent process, and access to the dataset is restricted in accordance with institutional and ethical regulations.
Related trials for Total Knee Arthroplasty
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruitingPhase 2
Nutrition and Swelling
Postoperative Recovery, Total Knee Arthroplasty
Recruiting
The Effect of Mind Mapping-Based Education on Postoperative Pain, Kinesiophobia, and Discharge Readiness in Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruitingObservational study
VRAS (Velys Robot-Assisted Solution) Operational Excellence Study
Total Knee Arthroplasty (TKA)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-Based Preoperative Education, Standard Verbal Preoperative Education and Total Knee Arthroplasty in people with Total Knee Arthroplasty and Surgical Fear and Worrying, run by Nermin Ocaktan 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 7 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: finished, as of the sponsor's last update on 12 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Fear (time frame: Preoperative period (one day before surgery)). 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 12 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.