Simulation-Based Preoperative Education in Total Knee Arthroplasty

NCT07310303 | Recruiting

• 1 other identifier: 2024-18-688
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Surgical Fear and Worrying; Kinesiophobia

Keywords

Total Knee Arthroplasty; Simulation-Based Education; Preoperative Education; Surgical Fear; Kinesiophobia; Nursing Intervention; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 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.

  Preoperative period (one day before surgery)

Secondary Outcomes (2)

• Kinesiophobia

  Postoperative period after recovery of cognitive function

• Postoperative Pain Intensity

  Early postoperative period during first mobilization

Study Arms (2)

Simulation-Based Preoperative Education

EXPERIMENTAL

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

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.

Other: Standard Verbal Preoperative Education; Procedure: Total Knee Arthroplasty

Interventions

Simulation-Based Preoperative Education OTHER

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

Simulation-Based Preoperative Education

Standard Verbal Preoperative Education OTHER

Routine verbal preoperative education provided according to institutional standards.

Standard Verbal Preoperative Education

Total Knee Arthroplasty PROCEDURE

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

Simulation-Based Preoperative Education; Standard Verbal Preoperative Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nermin Ocaktan: lead

Study Sites (1)

Acibadem Mehmet Ali Aydinlar University

Istanbul, Istanbul, 34752, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Kinesiophobia

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: January 15, 2025
• Primary Completion: January 30, 2026
• Study Completion: February 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)