- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310303
Simulation-Based Preoperative Education in Total Knee Arthroplasty
The Effect of Simulation-Based Preoperative Education on Surgical Fear and Kinesiophobia in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34752
- Acibadem Mehmet Ali Aydinlar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Simulation-Based Preoperative Education
Participants receive simulation-based preoperative education focusing on postoperative mobilization and recovery one day before surgery.
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Simulation-based education provided preoperatively to prepare patients for postoperative mobilization and recovery.
All participants in both study arms undergo standard total knee arthroplasty performed according to institutional clinical protocols.
|
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Active Comparator: Standard Verbal Preoperative Education
Participants receive routine standard verbal preoperative education according to institutional practice.
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Routine verbal preoperative education provided according to institutional standards.
All participants in both study arms undergo standard total knee arthroplasty performed according to institutional clinical protocols.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Preoperative period (one day before surgery)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinesiophobia
Time Frame: Postoperative period after recovery of cognitive function
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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.
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Postoperative period after recovery of cognitive function
|
|
Postoperative Pain Intensity
Time Frame: Early postoperative period during first mobilization
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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.
|
Early postoperative period during first mobilization
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-18-688
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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