Effectiveness of Digital Game-Based Learning in Teaching Surgical Site Infection Prevention to Nursing Students (PreSSI-DGBL)

February 19, 2026 updated by: hatice akaltun

Effectiveness of Digital Game-Based Learning for Teaching Surgical Site Infection Prevention Interventions: A Mixed-Methods Randomized Controlled Trial

This study aims to evaluate the effectiveness of digital game-based learning in teaching evidence-based surgical site infection prevention interventions to second-year nursing students. Using a mixed-methods randomized controlled design, students will be assigned to either a digital game-based learning group or a traditional theoretical education group.

Quantitative outcomes will assess changes in students' knowledge levels and cognitive load across three measurement points (baseline, 4-week post-intervention, and 8-week follow-up). In addition, qualitative data will be collected through semi-structured interviews with students in the intervention group to explore their learning experiences and perceptions of the digital learning approach.

The findings of this study are expected to contribute to evidence-based educational strategies in nursing education, particularly in the teaching of surgical site infection prevention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This mixed-methods randomized controlled trial is designed to compare the effectiveness of digital game-based learning with traditional theoretical education in teaching surgical site infection prevention interventions to second-year nursing students.

Participants will be randomly assigned to either an intervention group receiving digital game-based learning or a control group receiving instructor-led theoretical education based on current guidelines. Quantitative data will be collected using a three-time-point measurement design, including baseline assessment, a post-intervention assessment at the 4th week, and a follow-up assessment at the 8th week to evaluate knowledge retention and cognitive load associated with the learning process.

To complement the quantitative findings, a qualitative component will be conducted with students from the digital game-based learning group. Semi-structured interviews will be used to explore students' experiences, perceived benefits, and challenges related to the digital learning intervention. Qualitative data will be analyzed using thematic analysis.

By integrating quantitative and qualitative data, this study aims to provide a comprehensive evaluation of digital game-based learning as an innovative educational approach for teaching surgical site infection prevention in nursing education.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Undergraduate nursing students Students who voluntarily agree to participate and provide written informed consent Students who have not previously received formal education on surgical site infection prevention Students who are able to participate in the digital game-based learning intervention and outcome assessments

Exclusion Criteria:

  • Students who have previously received advanced or certified training on surgical site infection prevention Students who fail to complete any of the assessment time points (pre-test, post-test, or retention test) Students who do not complete the digital game-based learning intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital Game-Based Learning Group
Participants in this arm will receive a digital game-based learning intervention designed to teach evidence-based surgical site infection prevention interventions. The digital game includes interactive scenarios and learning tasks aligned with current guidelines. Participants will engage with the digital game as part of their educational activities during the study period.
Behavioral: Digital Game-Based Learning
The intervention consists of a digital game-based learning application developed to support the teaching of evidence-based surgical site infection prevention interventions. The digital game includes interactive learning activities designed to enhance engagement and reinforce key prevention principles in nursing education.
Other Names:
  • SSI Prevention Digital Game
Active Comparator: Traditional Theoretical Education Group
Participants in this arm will receive traditional instructor-led theoretical education on surgical site infection prevention based on current evidence-based guidelines. The education will be delivered using conventional teaching methods routinely applied in nursing education.
Behavioral: Traditional Theoretical Education
The intervention consists of traditional instructor-led theoretical education on surgical site infection prevention delivered using standard teaching methods routinely applied in undergraduate nursing education.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Knowledge of Surgical Site Infection Prevention
Time Frame: Baseline (pre-test), 4 weeks, and 8 weeks
This outcome measure assesses participants' knowledge of evidence-based surgical site infection prevention practices using a study-specific multiple-choice knowledge test consisting of 20 items (score range: 0-100), with higher scores indicating greater knowledge. Knowledge assessments will be conducted at three time points: baseline (pre-test), post-intervention at 4 weeks, and follow-up (knowledge retention test) at 8 weeks.
Baseline (pre-test), 4 weeks, and 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cognitive Load
Time Frame: 4 weeks, and 8 weeks
This outcome measure will assess participants' perceived cognitive load during the learning process using the Paas Cognitive Load Scale. The scale consists of a single-item, 9-point rating scale that measures the mental effort invested during learning (1 = very, very low mental effort; 9 = very, very high mental effort). Cognitive load assessments will be conducted at 4 weeks and at the 8-week follow-up.
4 weeks, and 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Digital Game-Based Learning Experiences (Qualitative Interviews)
Time Frame: After completion of the 8-week quantitative follow-up assessments
This outcome explores nursing students' experiences, perceptions, and views regarding the digital game-based learning intervention. Qualitative data will be collected through semi-structured individual interviews conducted with a purposive subsample of participants after completion of the 8-week quantitative follow-up assessments and analyzed using thematic analysis.
After completion of the 8-week quantitative follow-up assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
hatice akaltun

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yuzuncu Yil University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 15, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VYYU-SBF-HAKALTUN-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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