NCT07194148

Brief Summary

This randomized controlled trial aims to compare the effectiveness of a digital gamification-based training method and a traditional training method on instrument table layout skills in total hip replacement surgery. Nursing students will be randomly assigned to either a game-based learning group or a control group receiving conventional education. The primary outcome is the accuracy of surgical instrument placement. The study will be conducted at Bozok University in Turkey.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 26, 2025

Completed
19 days until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 18, 2025

Last Update Submit

September 27, 2025

Conditions

Keywords

Digital GamificationSurgical Instrument TableNursing EducationEducational Technology

Outcome Measures

Primary Outcomes (1)

  • Mean score on the Total Hip Replacement Instrument Table Checklist (0-100 points; higher scores = more accurate layout)

    The standardized checklist consists of 20 items. Each item is scored as correct (5 points) or incorrect (0 points). The total score ranges from 0 to 100. Higher scores indicate more accurate placement and organization of surgical instruments on the sterile table.

    Within 1 week after the intervention (post-training assessment)

Secondary Outcomes (1)

  • Mean score on the Training Satisfaction Questionnaire (5-point Likert scale; 1 = very dissatisfied, 5 = very satisfied; higher scores = greater satisfaction)

    Immediately after training session

Study Arms (2)

Digital Gamification Group

EXPERIMENTAL

Participants in this group will receive educational training using a custom-developed digital gamified simulation platform (ORNurse: Steril Setup 1.0) designed to teach surgical instrument table setup for total hip replacement surgery. Training includes interactive 3D simulation tasks and self-paced learning modules. Intervention: Name: Behavioral: Gamified Digital Education (ORNurse: Steril Setup 1.0) Other Names: ORNurse Game, Surgical Instrument Training Simulation Description: "A digital game developed to train surgical instrument table setup. Participants interact with simulation tasks and receive immediate feedback."

Behavioral: Gamified Digital Education (ORNurse: Steril Setup 1.0)

Traditional Training Group

ACTIVE COMPARATOR

Participants in this group will receive standard educational training consisting of a lecture-based presentation and printed materials on instrument table setup for total hip replacement surgery, delivered in a classroom setting. Intervention: Name: Behavioral: Traditional Training Other Names: Lecture-based Education, Printed Training Materials Description: "A classroom-based lecture accompanied by printed materials covering the correct surgical instrument table setup."

Behavioral: Traditional Training

Interventions

A behavioral intervention utilizing a custom-developed 3D digital game designed to teach perioperative nurses or students the correct layout of surgical instrument tables in total hip arthroplasty. The game includes interactive modules, feedback mechanisms, and simulated scenarios based on a validated protocol.

Also known as: ORNurse Game, Surgical Instrument Training Simulation
Digital Gamification Group

A classroom-based lecture accompanied by printed materials covering the correct surgical instrument table setup for total hip replacement surgery.

Also known as: Lecture-based Education, Printed Training Materials
Traditional Training Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Nursing students or perioperative nurses
  • No prior formal training in surgical instrument table setup for total hip arthroplasty
  • Willing and able to participate in digital or traditional training sessions
  • Provided informed consent

You may not qualify if:

  • Prior experience with surgical instrument table setup in orthopedic surgeries
  • Visual, cognitive, or motor impairments that limit ability to complete training tasks
  • Currently participating in another interventional education study
  • Refusal to participate or withdraws consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bozok University, School of Health Services (SHMYO)

Yozgat, Yozgat, 66000, Turkey (Türkiye)

Location

Study Officials

  • Emine İYİGÜN, Professor, PhD, RN

    Gülhane Faculty of Nursing, University of Health Sciences

    STUDY DIRECTOR

Central Study Contacts

DERYA ESENKAYA, MSc

CONTACT

Emine İYİGÜN, Professor, PhD, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking was applied since participants and researchers are aware of the assigned intervention.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned to either the digital gamification group or the traditional training group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 18, 2025

First Posted

September 26, 2025

Study Start

October 15, 2025

Primary Completion

December 15, 2025

Study Completion

January 15, 2026

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual participant data (IPD) from this study with other researchers. The collected data will be used exclusively for internal analysis and reporting purposes within the scope of the principal investigator's doctoral research. No external data sharing will occur.

Locations