Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-24 @ 10:41 PM
Study NCT ID:
NCT07028892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-19
First Post:
2025-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gamified Learning for Pressure Injury Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-06-11', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pressure Ulcer Knowledge Level', 'timeFrame': '10 weeks', 'description': 'The Outcome will be measured by "The Pressure Ulcer Knowledge Assessment Tool (PUKAT 2.0)". PUKAT 2.0 is a 26-item questionnaire that assesses nurses\' knowledge of pressure injury in six areas: etiology and development (six items), classification and observation (five items), risk assessment (two items), and nutrition (one item).'}, {'measure': 'Attitude Towards Pressure Ulcer Prevention', 'timeFrame': '10 weeks', 'description': 'Attitude Towards Pressure Ulcer Prevention instrument (APuP) will be used for defining attitude level of ICU nurses. APuP is a reliable and valid instrument to assess attitudes towards pressure ulcer prevention. There are 13 items in this scale, each of them evaluated with a 5-point Likert.'}], 'secondaryOutcomes': [{'measure': 'System Usability', 'timeFrame': '10 weeks', 'description': 'System Usability Scale (SUS) will be used. In this study, a gamified mobile application for the prevention of pressure injuries will be developed. SUS will be used to evaluate the usability of the application.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care nurses', 'gamification', 'mobile learning', 'pressure injuries'], 'conditions': ['Pressure Injuries', 'Pressure Ulcer Prevention']}, 'referencesModule': {'references': [{'pmid': '30730304', 'type': 'BACKGROUND', 'citation': "Aydogan S, Caliskan N. A Descriptive Study of Turkish Intensive Care Nurses' Pressure Ulcer Prevention Knowledge, Attitudes, and Perceived Barriers to Care. Wound Manag Prev. 2019 Feb;65(2):39-47."}, {'type': 'BACKGROUND', 'citation': 'Bozkurt, S. A., Samia, R., & Gazarian, P. K. (2023). Using standardized patient simulation in undergraduate nursing education: A scoping review. Clinical Simulation in Nursing, 74, 3-18. https://doi.org/10.1016/j.ecns.2022.10.003'}, {'pmid': '20466370', 'type': 'BACKGROUND', 'citation': 'Beeckman D, Defloor T, Demarre L, Van Hecke A, Vanderwee K. Pressure ulcers: development and psychometric evaluation of the attitude towards pressure ulcer prevention instrument (APuP). Int J Nurs Stud. 2010 Nov;47(11):1432-41. doi: 10.1016/j.ijnurstu.2010.04.004. Epub 2010 May 14.'}, {'pmid': '28547752', 'type': 'BACKGROUND', 'citation': 'Manderlier B, Van Damme N, Vanderwee K, Verhaeghe S, Van Hecke A, Beeckman D. Development and psychometric validation of PUKAT 2.0, a knowledge assessment tool for pressure ulcer prevention. Int Wound J. 2017 Dec;14(6):1041-1051. doi: 10.1111/iwj.12758. Epub 2017 May 26.'}]}, 'descriptionModule': {'briefSummary': "The goal of this Randomized Controlled Trial is to define the effect of gamified teaching methods for pressure injury prevention in intensive care nurses. The main questions it aims to answer are:\n\nH1: The gamified learning experience will increase the nurses' knowledge of pressure injury prevention compared to the control group.\n\nH2: The gamified learning experience will increase the nurses' skills in pressure injury prevention compared to the control group.\n\nH3: The gamified learning experience will increase the nurses' attitude toward pressure injury prevention compared to the control group.\n\nResearchers will compare two arm to see if there is a difference in knowledge, skills, and attitudes. Participants in the experimental group will be educated via a gamified mobile learning application.", 'detailedDescription': 'The inclusion criteria for the participants are: (a) being a registered nurse for more than one year, (b) being more than 18 years old, (c) having at least an associate degree in nursing, and (d) having a smartphone or tablet to be able to download the game application.\n\nThe Pressure Ulcer Knowledge Assessment Tool (PUKAT) will assess PI knowledge (Manderlier et al., 2017)\n\nThe Attitude Towards Pressure Ulcer Prevention instrument (APuP) will assess PI attitude (Beeckman et al., 2010) .\n\nPI assessment skills will be performed in the skills laboratory at the Tan Chingfen Graduate School of Nursing with pressure injuries in various stages (stage one, stage two, stage three, stage four, unstageable stage, and deep tissue pressure injury) on the wound model. The researchers will create and validate a "Pressure Injury Evaluation Form."'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being Registered Nurse for more than 1 year\n* Having at least an associate degree of nursing\n* Having a smart-phone or tablet\n* Being more than 18 years old\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07028892', 'briefTitle': 'Gamified Learning for Pressure Injury Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Mehmet Akif Ersoy University'}, 'officialTitle': 'Gamified Learning for Pressure Injury Prevention: A Randomized Controlled Trial to Enhance Knowledge, Skills, and Attitudes Among Nurses', 'orgStudyIdInfo': {'id': 'MehmetAkifU-SBF-SA-2'}, 'secondaryIdInfos': [{'id': '40099', 'type': 'OTHER_GRANT', 'domain': 'American Association of Critical-Care Nurses'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Experimental Group will receive an education about pressure injury prevention via a gamified mobile application', 'interventionNames': ['Device: A gamified mobile learning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The Control Group will receive the training via a booklet.', 'interventionNames': ['Other: Booklet training']}], 'interventions': [{'name': 'A gamified mobile learning', 'type': 'DEVICE', 'description': 'There will be a gamified environment in a mobile application with case scenarios on pressure injury prevention designed by researchers.', 'armGroupLabels': ['Experimental Group']}, {'name': 'Booklet training', 'type': 'OTHER', 'description': 'Nurses will receive training via a booklet about prevention of pressure injuries.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01655', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Sonia Martinath', 'role': 'CONTACT', 'email': 'ResearchInformaticsCore@umassmed.edu', 'phone': '(508) 856-8999'}, {'name': 'Priscilla Gazarian, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UMass Chan Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Sinan Aydogan, Ph.D.', 'role': 'CONTACT', 'email': 'saydogan@mehmetakif.edu.tr', 'phone': '+905457137919'}, {'name': 'Priscilla Gazarian, Ph.D.', 'role': 'CONTACT', 'email': 'Priscilla.Gazarian@umassmed.edu'}], 'overallOfficials': [{'name': 'Semiha Asli Bozkurt, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts College of Pharmacy and Health Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mehmet Akif Ersoy University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts Chan Medical School, Worcester', 'class': 'UNKNOWN'}, {'name': 'Massachusetts College of Pharmacy and Health Science', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sinan Aydoğan', 'investigatorAffiliation': 'Mehmet Akif Ersoy University'}}}}