Surgical EducationORNurseNCT07194148
Digital Gamification vs. Traditional Training for Hip Replacement Instrument Table Setup (ORNurse)
A study testing Gamified Digital Education (ORNurse: Steril Setup 1.0) and Traditional Training in people with Surgical Education and Operating Room Nursing, run by DERYA ESENKAYA at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Education, Operating Room Nursing, Educational Technology
- What is being tested?
- Gamified Digital Education (ORNurse: Steril Setup 1.0) and Traditional Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 15 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bozok University, School of Health Services (SHMYO)
Yozgat, Yozgat, 66000
DERYA ESENKAYA, 05072788742, derya.esenkaya@yobu.edu.tr
About this study
Official title: Comparison of the Effectiveness of the Digital Gamification Training Method Developed for Total Hip Replacement Surgery Instrument Table Layout and the Traditional Training Method: A Randomized Controlled Trial
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.
Read the detailed description
This study was designed to address the lack of standardized training protocols in instrument table setup for total hip arthroplasty. A digital gamified training tool (ORNurse: Steril Setup 1.0) was developed based on a validated surgical table protocol and integrated with a 3D simulation environment. The intervention group will receive hands-on training through the game, while the control group will receive traditional lecture-based training. The study will evaluate the effectiveness of the training methods on instrument layout accuracy, as well as participants' satisfaction and knowledge retention. This study aims to improve perioperative nursing education and promote standardization in surgical preparation processes.
- Being tested
- Gamified Digital Education (ORNurse: Steril Setup 1.0), Traditional Training
- Keywords
- Digital Gamification, Surgical Instrument Table, Nursing Education, Educational Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamified Digital Education (ORNurse: Steril Setup 1.0)Behavioural
Also called ORNurse Game, Surgical Instrument Training Simulation
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.
Traditional TrainingBehavioural
Also called Lecture-based Education, Printed Training Materials
A classroom-based lecture accompanied by printed materials covering the correct surgical instrument table setup for total hip replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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." Receives: 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." Receives: Behavioral: Traditional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The Training Satisfaction Questionnaire includes 10 items evaluating clarity, usability, and overall training experience. Each item is scored from 1 (very dissatisfied) to 5 (very satisfied). The mean total score is calculated, with higher scores indicating greater satisfaction with the training method.
Measured: Immediately after training session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either the digital gamification group or the traditional training group.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DERYA ESENKAYA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DERYA ESENKAYA, Bozok University
- Investigators
- Emine İYİGÜN, Professor, PhD, RN, Study director, Gülhane Faculty of Nursing, University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194148
- Sponsor's protocol ID
- BozokU-TKP2025-01
- Acronym
- ORNurse
- Status last verified
- Sep 2025
- First submitted
- 18 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of the Digital Gamification Training Method Developed for Total Hip Replacement Surgery Instrument Table Layout and the Traditional Training Method: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07194148
- Acronym / sponsor ID
- ORNurse / BozokU-TKP2025-01
- Keywords
- Digital Gamification, Surgical Instrument Table, Nursing Education, Educational Technology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- DERYA ESENKAYAUniversity, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Jan 2026 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study was designed to address the lack of standardized training protocols in instrument table setup for total hip arthroplasty. A digital gamified training tool (ORNurse: Steril Setup 1.0) was developed based on a validated surgical table protocol and integrated with a 3D simulation environment. The intervention group will receive hands-on training through the game, while the control group will receive traditional lecture-based training. The study will evaluate the effectiveness of the training methods on instrument layout accuracy, as well as participants' satisfaction and knowledge retention. This study aims to improve perioperative nursing education and promote standardization in surgical preparation processes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either the digital gamification group or the traditional training group.
| Arm | Type | Receives |
|---|---|---|
| Digital Gamification Group | Experimental | Behavioral: Gamified Digital Education (ORNurse: Steril Setup 1.0)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." |
| Traditional Training Group | Active comparator | Behavioral: Traditional TrainingParticipants 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." |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamified Digital Education (ORNurse: Steril Setup 1.0)Also: ORNurse Game, Surgical Instrument Training SimulationA 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. | Behavioural | Digital Gamification Group |
| Traditional TrainingAlso: Lecture-based Education, Printed Training MaterialsA classroom-based lecture accompanied by printed materials covering the correct surgical instrument table setup for total hip replacement surgery. | Behavioural | Traditional Training Group |
Primary outcome
Mean score on the Total Hip Replacement Instrument Table Checklist (0-100 points; higher scores = more accurate layout)
Time frame: Within 1 week after the intervention (post-training assessment)
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.
1 secondary outcome
Mean score on the Training Satisfaction Questionnaire (5-point Likert scale; 1 = very dissatisfied, 5 = very satisfied; higher scores = greater satisfaction)
Time frame: Immediately after training session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emine İYİGÜN, Professor, PhD, RN study director
Gülhane Faculty of Nursing, University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamified Digital Education (ORNurse: Steril Setup 1.0) and Traditional Training in people with Surgical Education and Operating Room Nursing, run by DERYA ESENKAYA at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DERYA ESENKAYA, MSc (05072788742, derya.esenkaya@yobu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean score on the Total Hip Replacement Instrument Table Checklist (0-100 points; higher scores = more accurate layout) (time frame: Within 1 week after the intervention (post-training assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.