Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-24 @ 2:44 PM
Study NCT ID:
NCT07168759
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-11
First Post:
2025-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Educational VR Game Intervention to Enhance Hygiene Practices in Primary School Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2160}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the compliance with hygiene practices immediately after intervention', 'timeFrame': 'Day 0, Month 1, Month 2', 'description': 'Knowledge of hygiene practices assessed through a true/false questionnaire.'}, {'measure': 'Change from baseline in the number of participants who comply with hand washing procedures immediately after intervention', 'timeFrame': 'Day 0, Month 1, Month 2', 'description': 'Hand washing procedure compliance measured using video recordings.'}, {'measure': 'Change from baseline in the number of bacteria on the hands of the participants immediately after intervention', 'timeFrame': 'Day 0, Month 1, Month 2', 'description': 'Bacterial counts on the hands of participants will be assessed using hand swab sampling and quantitative microbiological analysis. Specifically, hand swabs will be collected from the participants before and after intervention. This will be followed by using plate count method to detect the number of bacterial cells present on the hand swabs collected from the participants.'}, {'measure': 'Change from baseline in the vaccination uptake rates by the participants immediately after intervention', 'timeFrame': 'Day 0, Month 1, Month 2', 'description': 'Data on vaccination uptake rates will be collected from the participants using a standardized questionnaire before and after intervention. The data will be aggregated to calculate the percentage change in vaccination uptake rates from pre- to post-intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VR games', 'Hygiene compliance', 'Hand hygiene', 'Upper respiratory tract infections', 'Schoolchildren'], 'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to investigate if VR game-based educational intervention can enhance primary schoolchildren's compliance with hygiene practices to prevent the transmission of SARS-CoV-2 and other upper respiratory pathogens in the community.\n\nThe main questions the study aims to answer are, after receiving the VR game-based education intervention:\n\n* Does VR game-based educational intervention improve hygiene-practice compliance in primary schoolchildren?\n* What are the bacterial loads on primary schoolchildren's hands?\n* What are the rates of infections caused by SARS-CoV-2 and other respiratory viruses in primary schoolchildren?\n\nResearchers will compare the interventional group to the control group to see if VR game-based educational intervention can enhance primary schoolchildren's hygiene practices.\n\nParticipants will\n\n* Receive in a training programme on hygiene practices through playing VR games for two weeks, 1 hour per week.\n* Do a questionnaire on hygiene knowledge before and after receiving the education programme\n* Provide hand swabs and saliva samples before and after receiving the education programme", 'detailedDescription': "This study aims to evaluate the effectiveness of a VR game (VRG)-based educational program on hygiene practices among primary schoolchildren in Hong Kong. The research design employs a randomized controlled trial with repeated measures.\n\nParticipants will be primary schoolchildren aged 6 to 12 who can communicate and read in Chinese. To minimize selection bias, children will remain unaware of their group assignments. The sample size calculation aims for a statistical power of at least 0.8, targeting 2160 participants across 18 school clusters. Thirty-six local primary schools will be randomly assign to the intervention group or the control group in a ratio of 1:1.\n\nThe pilot phase will refine the VRG educational program based on feedback from a previous intervention. Two schools will be selected for this pilot, where trained teachers will assist in student recruitment. The main intervention will involve an VRG-based educational program delivered over two to three weeks. Children in the intervention group will engage with VRGs that cover topics such as SARS-CoV-2 and influenza virus transmission, hygiene practices, importance of rapid testing and vaccination in the prevention of upper respiratory tract infections. The control group will receive standard community health education and will be invited to participate in the VRG program after the intervention period.\n\nEach child's involvement will last six months, with assessments occurring at baseline (T1) and at two subsequent intervals: immediately-post (T2), 1-month post (T3). Data collection will include demographic data, questionnaire to assesses hygiene knowledge, videos to record handwashing practices, hand swabs to measures bacterial loads on hands and saliva samples to tests for respiratory viruses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary schoolchildren aged 6-12 years.\n* Able to communicate in Chinese and to read Chinese.\n\nExclusion Criteria:\n\n* Reported mental or physical health disorders.\n* Participated in other health educational programs related to hygiene practices 2 months or less before recruitment.'}, 'identificationModule': {'nctId': 'NCT07168759', 'briefTitle': 'Educational VR Game Intervention to Enhance Hygiene Practices in Primary School Children', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'An Educational Intervention Using a Virtual Reality Game to Improve Compliance With Coronavirus 2019 Disease-related Hygiene Practices and Participation in Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) Screening, for the Prevention of SARS-CoV-2 Transmission Between Primary Schoolchildren in Communities: a Stratified Cluster-randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'HMRF2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'School children will participate in a VR game-based education programme', 'interventionNames': ['Other: VR game -based education program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Schoolchildren in this group will receive the usual health education'}], 'interventions': [{'name': 'VR game -based education program', 'type': 'OTHER', 'description': 'The schoolchildren in the intervention group participate in an innovative VR game-based educational programme featuring: (1) Web-based health education on (i) SARS-CoV-2 and Influenza virus transmission, (ii) proper hand and respiratory hygiene practices and (iii) the importance of rapid screening and vaccination in the prevention of upper respiratory tract infections.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'China', 'facility': 'The Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}