- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07467902
12 Steps of a Modified Handwashing Program on Health Outcomes and School Absenteeism (Hand hygiene)
THE IMPACT OF HAND HYGIENE INTERVENTION ON HEALTH OUTCOMES AND SCHOOL ABSENTEEISM AMONG BASIC SCHOOL CHILDREN IN ERBIL CITY
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.
The main questions it aims to answer are:
This 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.
- Describe socio-demographic characteristics of participants (school children).
- Assess the impact of hand and respiratory hygiene intervention on the incidence rate of respiratory illnesses.
- Assess the impact of hand and respiratory hygiene intervention on the incidence rate of gastrointestinal illnesses.
- Assess the impact of hand and respiratory hygiene intervention on the length of illness absence episodes.
- Determine the factors associated with the increased or reduced impact of hand and respiratory hygiene intervention on school absenteeism.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Control 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.
Intervention 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.
Follow 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Erbil Governorate
-
Erbil, Erbil Governorate, Iraq, 44001
- Hawler Medical University/College of nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hand Hygiene Intervention Group
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.
|
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.
|
|
No Intervention: (Control Group)
Students in this group continue their regular school routine without receiving the structured hand hygiene education program during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the impact of hand and respiratory hygiene on the incidence rate of respiratory illnesses and gastrointestinal illnesses.
Time Frame: 5 months (Measured at baseline and at the conclusion of the study).
|
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.
|
5 months (Measured at baseline and at the conclusion of the study).
|
|
School Absenteeism Due to Illness
Time Frame: 5 months
|
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.
|
5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nazar pols Shabila, Professor, Hawler Medical University/College of nursing
Publications and helpful links
General Publications
- 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.
- 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.
- Sarwar, S., Muhammad, J. and Shahzad, F., 2022. A modified hand washing method for resource limited settings. Frontiers in Public Health, 10, p.965853.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMU nursing college
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Respiratory Disease
-
Altesa Biosciences, Inc.CompletedHealthy | Pulmonary Disease | COPD | Respiratory Disease | Lower Respiratory DiseaseUnited States
-
Altesa Biosciences, Inc.Virtus Respiratory ResearchCompletedRCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory InfectionInfections | Virus Diseases | Respiratory Tract Infections | Respiratory Tract Diseases | Lung Diseases | Pulmonary Disease, Chronic Obstructive | Enterovirus Infections | Copd | Pulmonary Disease | Respiratory Disease | Respiratory Complication | Upper Respiratory Tract Infections | Respiratory Viral Infection | ... and other conditionsUnited Kingdom
-
FisioRespiraciónUniversidad Complutense de Madrid; NeumomadridUnknownAcute Disease RespiratorySpain
-
Società Italiana di Allergologia, Asma e Immunologia...Società Italiana di Allergologia e Immunologia Pediatrica (SIAIP)Recruiting
-
Rochester General HospitalCompletedAspirin-exacerbated Respiratory DiseaseUnited States
-
SOS Oxygene MediterraneeRecruitingExercise | Chronic Respiratory DiseaseFrance
-
Larissa University HospitalRecruitingRespiratory Disease (Clinically Stable Individuals - Patients Recovered From Respiratory Disease)Greece
-
West Park Healthcare CentreEnrolling by invitation
-
KorianCompletedChronic Respiratory DiseaseFrance
-
Rambam Health Care CampusUnknown
Clinical Trials on Hand Hygiene Education Program
-
Izmir Katip Celebi UniversityCompletedAbsenteeism | Hand Hygiene | Respiratory Tract; Infection, Upper (Acute)Turkey
-
Chang Gung Memorial HospitalEnrolling by invitationQuality of Life | Oral Hygiene | Sleep Quality | Oral Health Care | Noninvasive VentilatorsTaiwan
-
Ozturk Gurer Tutu, MDCompletedEssential Hypertension | Sleep Quality | Primary CareTurkey (Türkiye)
-
Karabuk UniversityZonguldak Bulent Ecevit UniversityNot yet recruitingSelf Efficacy | Sleep Hygiene | Infant Sleeping Habits | Parent EducationTurkey (Türkiye)
-
Istanbul University - CerrahpasaThe Scientific and Technological Research Council of TurkeyRecruitingHospital InfectionTurkey
-
Istanbul Sultanbeyli State HospitalCompleted
-
Aylin OlgunCompletedMenstruation | Health Education | Visually Impaired Persons | Nursing | Self-care | Menstruation HygieneTurkey (Türkiye)
-
Fundación Clínica ShaioCompletedNosocomial Infection | Healthcare-Associated Infections (HAIs)Colombia
-
Institut Catala de SalutCEEISCAT; Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaCompletedIntervention in Hand Hygiene for Infectious Diseases PreventionSpain
-
National Cheng-Kung University HospitalRecruitingObstructive Sleep Apnea of AdultTaiwan