Simulation-Based Preoperative Education in Total Knee Arthroplasty

NCT ID: NCT07310303

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Total Knee Arthroplasty Surgical Fear and Worrying Kinesiophobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Simulation-Based Preoperative Education

Participants receive simulation-based preoperative education focusing on postoperative mobilization and recovery one day before surgery.

Group Type EXPERIMENTAL

Simulation-Based Preoperative Education

Intervention Type OTHER

Simulation-based education provided preoperatively to prepare patients for postoperative mobilization and recovery.

Total Knee Arthroplasty

Intervention Type PROCEDURE

All participants in both study arms undergo standard total knee arthroplasty performed according to institutional clinical protocols.

Standard Verbal Preoperative Education

Participants receive routine standard verbal preoperative education according to institutional practice.

Group Type ACTIVE_COMPARATOR

Standard Verbal Preoperative Education

Intervention Type OTHER

Routine verbal preoperative education provided according to institutional standards.

Total Knee Arthroplasty

Intervention Type PROCEDURE

All participants in both study arms undergo standard total knee arthroplasty performed according to institutional clinical protocols.

Interventions

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Simulation-Based Preoperative Education

Simulation-based education provided preoperatively to prepare patients for postoperative mobilization and recovery.

Intervention Type OTHER

Standard Verbal Preoperative Education

Routine verbal preoperative education provided according to institutional standards.

Intervention Type OTHER

Total Knee Arthroplasty

All participants in both study arms undergo standard total knee arthroplasty performed according to institutional clinical protocols.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nermin Ocaktan

OTHER

Sponsor Role lead

Responsible Party

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Nermin Ocaktan

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Acibadem Mehmet Ali Aydinlar University

Istanbul, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Nermin Ocaktan, PhD

Role: primary

05337373306

Other Identifiers

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2024-18-688

Identifier Type: -

Identifier Source: org_study_id

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