Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-08 @ 5:45 PM
Study NCT ID:
NCT07423702
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Digital Game-Based Learning in Teaching Surgical Site Infection Prevention to Nursing Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned to either a digital game-based learning group or a traditional theoretical education group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-15', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Digital Game-Based Learning Experiences (Qualitative Interviews)', 'timeFrame': 'After completion of the 8-week quantitative follow-up assessments', 'description': "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."}], 'primaryOutcomes': [{'measure': 'Knowledge of Surgical Site Infection Prevention', 'timeFrame': 'Baseline (pre-test), 4 weeks, and 8 weeks', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Cognitive Load', 'timeFrame': '4 weeks, and 8 weeks', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital Game-Based Learning', 'Surgical Site Infection', 'Nursing Students', 'Educational Intervention', 'Infection Prevention'], 'conditions': ['Surgical Site Infection Prevention', 'Nursing Education']}, 'descriptionModule': {'briefSummary': "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.\n\nQuantitative 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.\n\nThe 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.", 'detailedDescription': "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.\n\nParticipants 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.\n\nTo 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.\n\nBy 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT07423702', 'acronym': 'PreSSI-DGBL', 'briefTitle': 'Effectiveness of Digital Game-Based Learning in Teaching Surgical Site Infection Prevention to Nursing Students', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Effectiveness of Digital Game-Based Learning for Teaching Surgical Site Infection Prevention Interventions: A Mixed-Methods Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'VYYU-SBF-HAKALTUN-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital Game-Based Learning Group', 'description': '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.', 'interventionNames': ['Behavioral: Digital Game-Based Learning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Theoretical Education Group', 'description': '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.', 'interventionNames': ['Behavioral: Traditional Theoretical Education']}], 'interventions': [{'name': 'Digital Game-Based Learning', 'type': 'BEHAVIORAL', 'otherNames': ['SSI Prevention Digital Game'], 'description': '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.', 'armGroupLabels': ['Digital Game-Based Learning Group']}, {'name': 'Traditional Theoretical Education', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Traditional Theoretical Education Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Van', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Van Yuzuncu Yil University', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}], 'centralContacts': [{'name': 'Hatice Akaltun, PhD', 'role': 'CONTACT', 'email': 'haticeakaltun@yyu.edu.tr', 'phone': '05425955326'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'hatice akaltun', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yuzuncu Yil University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer (PhD) in Nursing', 'investigatorFullName': 'hatice akaltun', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}