Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:14 AM
Study NCT ID:
NCT07410858
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality-Enhanced Parent Education in Neonatal Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Due to the nature of the educational intervention, participants and care providers cannot be blinded to group assignment. However, trained observers assessing parental caregiving practices and data analysts will remain blinded to allocation to reduce assessment bias.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a single-center, parallel-group, randomized pilot clinical trial comparing virtual reality-enhanced parent education with standard NICU parent education. Participants will be randomly assigned in a 1:1 ratio to either the intervention group receiving VR-enhanced education or the control group receiving routine education. Both groups will be followed concurrently to evaluate feasibility, parental knowledge, caregiving practices, and intervention tolerability.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-07', 'studyFirstSubmitQcDate': '2026-02-07', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental Neonatal Intensive Care Unit Caregiving Practices', 'timeFrame': 'Within 24-48 hours after completion of the parent education intervention', 'description': 'Parental caregiving practices will be assessed using a structured observational checklist measuring performance of bedside neonatal care activities, including hand hygiene, safe positioning and containment, diapering and basic hygiene, and non-nutritive soothing and clustering of care. Each checklist item is scored as completed or not completed, with higher total scores indicating better caregiving practice performance.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Neonatal Intensive Care Units', 'Parent Education', 'Premature Infant'], 'conditions': ['Neonatal Intensive Care Units', 'Premature Infant', 'Parent Education', 'Virtual Reality', 'Health Knowledge, Attitudes, Practice']}, 'descriptionModule': {'briefSummary': "This randomized pilot clinical trial aims to evaluate the effectiveness and feasibility of virtual reality (VR)-enhanced parent education in improving neonatal intensive care unit (NICU) caregiving practices among parents of hospitalized neonates. The study will also examine the safety and tolerability of VR use among parents.\n\nResearchers will compare VR-enhanced education with standard NICU parent education to determine whether immersive VR training improves parents' knowledge, confidence, and ability to perform caregiving tasks.\n\nParticipants will be randomly assigned to receive either VR-enhanced education or standard education. Participants receiving VR education will engage in short immersive sessions demonstrating NICU orientation and caregiving procedures. All participants will complete assessments and observations related to caregiving practices and VR tolerability throughout the study period.", 'detailedDescription': 'The NICU environment presents significant emotional, educational, and practical challenges for parents of preterm or critically ill neonates. Effective parent education is essential for improving caregiving competence, reducing parental anxiety, and supporting family-integrated neonatal care. However, traditional education methods such as verbal instructions and printed materials may be limited by time constraints, parental stress, and variations in health literacy.\n\nVirtual reality technology provides immersive, interactive educational experiences that may enhance understanding, engagement, and retention of caregiving information. VR simulations can provide parents with guided orientation to NICU equipment, caregiving demonstrations, and exposure to real-life caregiving scenarios in a safe, controlled environment.\n\nThis study is designed as a single-center, randomized, parallel-group pilot trial conducted in a neonatal intensive care unit setting. The primary purpose of the trial is to evaluate feasibility outcomes including recruitment, adherence, retention, and VR tolerability, as well as to generate preliminary estimates of effect size and variability to inform future large-scale trials.\n\nParticipants assigned to the intervention group will receive a standardized VR education package consisting of immersive orientation and caregiving simulation sessions delivered using a VR headset. Sessions will include demonstrations of routine neonatal care activities and structured debriefing discussions to reinforce learning and address parental questions.\n\nParticipants assigned to the control group will receive routine NICU parent education delivered through conventional methods currently implemented in clinical practice.\n\nData collection will include assessments of parental knowledge, direct observation of caregiving practices, and evaluation of VR-related tolerability and user experience. Observations of caregiving practices will be conducted by trained observers who are blinded to group allocation to reduce assessment bias.\n\nThe results of this pilot trial will provide essential data regarding feasibility, acceptability, safety, and potential effectiveness of VR-enhanced parent education. Findings will be used to refine intervention procedures, improve study methodology, and support the development of a larger definitive randomized clinical trial aimed at improving neonatal outcomes and family-centered care in NICU settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent or legal guardian of a neonate admitted to the Neonatal Intensive Care Unit (NICU) within 72 hours of admission\n* Age 18 years or older\n* Able to read and understand the study language (Arabic)\n* Willing to provide informed consent and participate in study procedures\n\nExclusion Criteria:\n\n* Parent with a confirmed diagnosis of epilepsy, vestibular disorder, or any medical condition that contraindicates virtual reality exposure\n* Parent of a neonate expected to be discharged or transferred within 48 hours\n* Parent unable to complete study procedures or assessments'}, 'identificationModule': {'nctId': 'NCT07410858', 'briefTitle': 'Virtual Reality-Enhanced Parent Education in Neonatal Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'Jouf University'}, 'officialTitle': 'Virtual Reality-Enhanced Parent Education and Its Effect on Neonatal Intensive Care Practices: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '351-12-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR-Enhanced Parent Education', 'description': 'Participants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing.', 'interventionNames': ['Behavioral: Virtual Reality-Enhanced Parent Education']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Parent Education', 'description': 'Participants receive routine NICU parent education including verbal instructions and printed educational materials according to unit standard practice.'}], 'interventions': [{'name': 'Virtual Reality-Enhanced Parent Education', 'type': 'BEHAVIORAL', 'otherNames': ['Standard Parent Education'], 'description': 'Participants receive virtual reality-enhanced parent education including immersive NICU orientation and caregiving simulation sessions delivered using a VR headset, followed by structured debriefing.', 'armGroupLabels': ['VR-Enhanced Parent Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41522', 'city': 'Ismailia', 'state': 'Ismailia, Egypt.', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Lareen M. Abo-Seif, Lecturer', 'role': 'CONTACT', 'email': 'Faculty.of.nursing@nursing.suez.edu.eg'}, {'name': 'Osama M. Ramadan, Lecturer', 'role': 'CONTACT', 'email': 'Omer@ju.edu.sa', 'phone': '00966580408319'}], 'facility': 'Neonatal Intensive Care Unit (NICU), Suez Canal University Hospital', 'geoPoint': {'lat': 30.60427, 'lon': 32.27225}}], 'centralContacts': [{'name': 'Nadia B. Elsharkawy, Assoc.Prof.', 'role': 'CONTACT', 'email': 'nelsharkawy@ju.edu.sa', 'phone': '00966554180474'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available to other researchers. Data generated during this study will remain confidential and will only be used for the purposes outlined in this trial.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jouf University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nadia Elsharkawy', 'investigatorAffiliation': 'Jouf University'}}}}