Viewing Study NCT07310303


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Ignite Modification Date: 2026-03-30 @ 1:20 AM
Study NCT ID: NCT07310303
Status: RECRUITING
Last Update Posted: 2026-01-05
First Post: 2025-12-16
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Simulation-Based Preoperative Education in Total Knee Arthroplasty
Sponsor: Nermin Ocaktan
Organization:

Study Overview

Official Title: The Effect of Simulation-Based Preoperative Education on Surgical Fear and Kinesiophobia in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
Status: RECRUITING
Status Verified Date: 2025-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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. 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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: