Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 12:26 PM
Study NCT ID:
NCT07467902
Status:
COMPLETED
Last Update Posted:
2026-03-12
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
12 Steps of a Modified Handwashing Program on Health Outcomes and School Absenteeism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Single (Outcomes Assessor)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 802}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the impact of hand and respiratory hygiene on the incidence rate of respiratory illnesses and gastrointestinal illnesses.', 'timeFrame': '5 months (Measured at baseline and at the conclusion of the study).', 'description': 'Assess the impact of hand and respiratory hygiene intervention on the incidence rate of respiratory illnesses and assess the impact of hand and respiratory hygiene intervention on the incidence rate of gastrointestinal illnesses.'}, {'measure': 'School Absenteeism Due to Illness', 'timeFrame': '5 months', 'description': 'The number of school days missed due to illness among students during the study period. Absenteeism will be recorded from school attendance records and compared between the intervention and control groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Handwashing Hand hygiene School health Respiratory infections Gastrointestinal infections School absenteeism Cluster randomized controlled trial'], 'conditions': ['Respiratory Disease', 'Gastrointestinal Diseases and Symptom']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Mbakaya, B.C., Lee, P. and Lee, R.L.T., 2019. Effect of a school-based hand hygiene program for Malawian children: A cluster randomized controlled trial. American Journal of Infection Control, 47(12), pp.1460-1464.'}, {'type': 'BACKGROUND', 'citation': 'Or, P.P., Ching, P.T. and Chung, J.W., 2019. A program to improve the hand hygiene compliance of Hong Kong preschoolers with an insight into their absenteeism. American Journal of Infection Control, 47(5), pp.498-503.'}, {'type': 'BACKGROUND', 'citation': 'Sarwar, S., Muhammad, J. and Shahzad, F., 2022. A modified hand washing method for resource limited settings. Frontiers in Public Health, 10, p.965853.'}], 'seeAlsoLinks': [{'url': 'https://hmu.edu.krd/colleges/college-of-nursing', 'label': 'college of nursing site'}, {'url': 'https://www.cdc.gov/clean-hands/about/index.html', 'label': 'CDC when to wash your hands'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess whether providing hand and respiratory hygiene interventions in primary school children reduces the incidence rate of absence episodes due to illness in children during an academic year.\n\nThe main questions it aims to answer are:\n\nThis study aims to assess whether providing hand and respiratory hygiene interventions in primary school children reduces the incidence rate of absence episodes due to illness in children during an academic year.\n\n1. Describe socio-demographic characteristics of participants (school children).\n2. Assess the impact of hand and respiratory hygiene intervention on the incidence rate of respiratory illnesses.\n3. Assess the impact of hand and respiratory hygiene intervention on the incidence rate of gastrointestinal illnesses.\n4. Assess the impact of hand and respiratory hygiene intervention on the length of illness absence episodes.\n5. Determine the factors associated with the increased or reduced impact of hand and respiratory hygiene intervention on school absenteeism.', 'detailedDescription': "Parallel-group cluster randomized trials take place in primary schools, where schools are allocated using restricted randomization to the intervention or control group. All children (aged 9-13 years) in attendance at participating intervention schools will receive an in-class hand and respiratory hygiene education session and will be provided with soap, shampoo, and shampoo dispensers in school at the beginning of the starting trial (around November). The in-class hand and respiratory hygiene education sessions will be repeated on a monthly basis in the intervention schools.\n\nControl schools will not receive these specific interventions but will continue to receive any hygiene aspects included in the study program. The primary outcome is the number and length of absence episodes due to illness among follow-up children and the reasons for absence, including any respiratory and gastrointestinal infections during the academic year (November to May the following year). The incidence of respiratory and gastrointestinal illnesses will be recorded, even if they do not cause school absences.\n\nIntervention Children in intervention schools will receive an approximately 30-minute in-class hand hygiene education session at the beginning of the study. They will be instructed in the use of hand hygiene and asked to use it after coughing/sneezing and on the way out of the classroom for morning break and lunch. The in-class hand and respiratory hygiene education sessions will be repeated on a monthly basis. In addition, educational posters about hand hygiene and when and how to wash hands will be installed in each school (classrooms and/or corridors) as a reminder for schoolchildren. Caregivers of children at intervention schools will be sent a letter home with the school newsletter explaining the study and asking them to let their child's teacher know Control Children in the control schools will not receive specific hygiene education, and hand soap will not be provided in the school.\n\nFollow up The researcher will visit each school in both the intervention and control groups on a weekly basis to record any absenteeism of schoolchildren and follow up on the reasons with the school and the parents. The occurrence of any illnesses, even without absenteeism, will be recorded."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'genderBased': True, 'genderDescription': 'The study population comprised 802 students from twelve randomly selected public primary schools in Erbil, Iraq. Eligible participants were children enrolled in grades four to six (aged 9-13 years) attending public schools within Erbil city center. All students in the selected schools were invited to participate. Written informed consent was obtained from parents or guardians, and verbal agreement was provided by the children prior to enrollment.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study population comprised 802 students from twelve randomly selected public primary schools in Erbil, Iraq. Eligible participants were children enrolled in grades four to six (aged 9-13 years) attending public schools within Erbil city center. All students in the selected schools were invited to participate. Written informed consent was obtained from parents or guardians, and verbal agreement was provided by the children prior to enrollment.\n\nExclusion Criteria:\n\n* Exclusion criteria included students attending private, evening, or special schools (e.g., for children with disabilities), as well as those with chronic medical conditions likely to influence school attendance. Bilingual schools (English-Arabic) were excluded to maintain comparability in the educational environment.'}, 'identificationModule': {'nctId': 'NCT07467902', 'acronym': 'Hand hygiene', 'briefTitle': '12 Steps of a Modified Handwashing Program on Health Outcomes and School Absenteeism', 'organization': {'class': 'OTHER', 'fullName': 'Hawler Medical University'}, 'officialTitle': 'THE IMPACT OF HAND HYGIENE INTERVENTION ON HEALTH OUTCOMES AND SCHOOL ABSENTEEISM AMONG BASIC SCHOOL CHILDREN IN ERBIL CITY', 'orgStudyIdInfo': {'id': 'HMU nursing college'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hand Hygiene Intervention Group', 'description': 'Students in this group receive a structured hand hygiene education program that includes instruction on proper handwashing techniques, demonstrations, and reinforcement of hygiene practices to improve health outcomes and reduce school absenteeism.', 'interventionNames': ['Behavioral: Hand Hygiene Education Program']}, {'type': 'NO_INTERVENTION', 'label': '(Control Group)', 'description': 'Students in this group continue their regular school routine without receiving the structured hand hygiene education program during the study period.'}], 'interventions': [{'name': 'Hand Hygiene Education Program', 'type': 'BEHAVIORAL', 'description': 'Modified handwashing practice Children in intervention schools will receive an approximately 30 minutes of in-class hand hygiene education session at the beginning of the study. They will be instructed in the use of hand hygiene and asked to use it after coughing/sneezing and on the way out of the classroom for morning break and lunch. The in-class respiratory hygiene education sessions, Wearing masks and hand rub gel will be repeated every month. In addition, educational posters about hand hygiene, when and how to wash hands will be installed in each school (classrooms and/or corridors) as a reminder for schoolchildren.', 'armGroupLabels': ['Hand Hygiene Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44001', 'city': 'Erbil', 'state': 'Erbil Governorate', 'country': 'Iraq', 'facility': 'Hawler Medical University/College of nursing', 'geoPoint': {'lat': 36.19117, 'lon': 44.00943}}], 'overallOfficials': [{'name': 'Nazar pols Shabila, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hawler Medical University/College of nursing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hawler Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master In Community health Nursing', 'investigatorFullName': 'Muhammad Hasan Awla', 'investigatorAffiliation': 'Hawler Medical University'}}}}