Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 3:08 AM
Study NCT ID:
NCT07446920
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Effect of Artificial Intelligence-Driven Mobile Application on Nurses' Knowledge and Attitudes Toward Atraumatic Care for Hospitalized Children"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label study; no masking applied to participants, care providers, investigators, or outcome assessors.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants were randomly assigned to either the intervention group receiving the AI-driven mobile application or the control group receiving usual care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Nurses' Knowledge about Atraumatic Care", 'timeFrame': 'Pre-test and immediately post-intervention (after completing the mobile application modules).', 'description': "Change in nurses' knowledge scores regarding atraumatic care for hospitalized children, measured using a validated knowledge questionnaire administered before and after the AI-driven mobile application intervention."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atraumatic Care, Pediatric Nursing, Hospitalized Children, Nursing Education, AI, Mobile Application, RCT'], 'conditions': ['Pediatric Nursing Education']}, 'descriptionModule': {'briefSummary': "This randomized controlled trial aims to evaluate the effect of an artificial intelligence-driven mobile application on nurses' knowledge and attitudes toward atraumatic care for hospitalized children. Participants, who are pediatric nurses, will be randomly assigned to either the intervention group, using the mobile application, or the control group receiving standard education. The primary outcomes are improvements in nurses' knowledge and attitudes, measured after the intervention. The study seeks to determine whether the mobile application enhances nurses' competence in providing atraumatic care compared to usual training methods.", 'detailedDescription': "This randomized controlled trial investigates the effectiveness of an artificial intelligence-driven mobile application designed to enhance nurses' knowledge and attitudes toward atraumatic care for hospitalized children. Pediatric nurses working in hospital units will be randomly assigned to either the intervention group, which will use the mobile application, or the control group, which will receive standard education. The intervention aims to provide interactive learning modules, case scenarios, and practical guidelines for atraumatic care. Primary outcomes include improvements in knowledge scores and attitude assessments, measured before and after the intervention. Secondary outcomes include participants' satisfaction with the application and self-reported confidence in providing atraumatic care. The study is expected to provide evidence on the utility of mobile AI-based educational tools in improving nursing competence and patient care in pediatric settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study included nurses who:\n\nWork in the participating units and provide direct nursing care to children or neonates.\n\nOwn a smartphone and are capable of using it (as the intervention is delivered via a mobile application).\n\nAgree to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Nurses were excluded if they:\n\nPerform only administrative tasks (e.g., statistics/records) without providing direct patient care.\n\nAre expected to take long-term leave during the intervention/follow-up period'}, 'identificationModule': {'nctId': 'NCT07446920', 'briefTitle': '"Effect of Artificial Intelligence-Driven Mobile Application on Nurses\' Knowledge and Attitudes Toward Atraumatic Care for Hospitalized Children"', 'organization': {'class': 'OTHER', 'fullName': 'University of Baghdad'}, 'officialTitle': "Effect of Artificial Intelligence-Driven Mobile Application on Nurses' Knowledge and Attitude Toward Atraumatic Care for Hospitalized Children: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': '2025-11-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nurses Receiving Atraumatic Care Training"', 'description': 'Participants receive the AI-driven mobile application containing educational modules on atraumatic care, an interactive AI-based chat for at least three questions per module, module quizzes of 10 AI-generated questions, and a final assessment of 25 questions covering all modules. Completion of each module and quiz is required to advance', 'interventionNames': ['Behavioral: Atraumatic Care Training Program']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Nurses in this group will continue their routine practice without receiving any additional training, mobile application, or educational program. This group serves as a comparison to evaluate the effect of the AI-driven mobile application on the experimental group. Participants follow standard hospital protocols and provide care as usual, without exposure to the study intervention.', 'interventionNames': ['Behavioral: No Intervention / Standard Care']}], 'interventions': [{'name': 'Atraumatic Care Training Program', 'type': 'BEHAVIORAL', 'description': "The intervention consisted of an AI-driven mobile application designed to enhance nurses' knowledge and attitudes toward atraumatic care for hospitalized children. The application included educational modules covering principles, benefits, and purposes of atraumatic care. Each module provided AI-generated content and an interactive chat feature, requiring participants to ask at least three questions before unlocking a module-specific quiz. Participants completed all modules over one week, followed by a final assessment of 25 AI-generated questions covering all modules", 'armGroupLabels': ['Nurses Receiving Atraumatic Care Training"']}, {'name': 'No Intervention / Standard Care', 'type': 'BEHAVIORAL', 'description': 'Nurses in this group will continue their routine practice without receiving any additional training, mobile application, or educational program. Participants will provide pediatric care according to standard hospital protocols. This group serves as a comparison to evaluate the effect of the AI-driven mobile application on the experimental group.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Pediatric Hospital', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Baghdad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Effect of Artificial Intelligence-Driven Mobile Application on Nurses' Knowledge and Attitude toward Atraumatic Care for Hospitalized Children: A Randomized Controlled Trial", 'investigatorFullName': 'Mustafa Sahib Ali', 'investigatorAffiliation': 'University of Baghdad'}}}}