Respiratory DiseaseHand hygieneNCT07467902
12 Steps of a Modified Handwashing Program on Health Outcomes and School Absenteeism
A study testing Hand Hygiene Education Program in people with Respiratory Disease and Gastrointestinal Diseases and Symptom, run by Hawler Medical University at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease, Gastrointestinal Diseases and Symptom
- What is being tested?
- Hand Hygiene Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 1 siteIraq
- Study dates
- 1 Oct 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Hawler Medical University/College of nursing
Erbil, Erbil Governorate, 44001
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Hand Hygiene Education Program
- Keywords
- Handwashing Hand hygiene School health Respiratory infections Gastrointestinal infections School absenteeism Cluster randomized controlled trial
- Medical subject headings
- Respiration Disorders, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Hygiene Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Hand Hygiene Intervention Group | Experimental | 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. Receives: Behavioral: Hand Hygiene Education Program |
| (Control Group) | No intervention | Students in this group continue their regular school routine without receiving the structured hand hygiene education program during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the impact of hand and respiratory hygiene on the incidence rate of respiratory illnesses and gastrointestinal illnesses.
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.
Measured: 5 months (Measured at baseline and at the conclusion of the study).
School Absenteeism Due to Illness
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Oct 2024
- Primary completion15 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hawler Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Hasan Awla, Hawler Medical University
- Investigators
- Nazar pols Shabila, Professor, Study director, Hawler Medical University/College of nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467902
- Sponsor's protocol ID
- HMU nursing college
- Acronym
- Hand hygiene
- Status last verified
- Mar 2026
- First submitted
- 10 Feb 2026
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mbakaya BC, Lee P, Lee RLT. Effect of a school-based hand hygiene program for Malawian children: A cluster randomized controlled trial. Am J Infect Control. 2019 Dec;47(12):1460-1464. doi: 10.1016/j.ajic.2019.06.009. Epub 2019 Jul 16.
PubMed 31324487Or PPL, Ching PTY, Chung JWY. A program to improve the hand hygiene compliance of Hong Kong preschoolers with an insight into their absenteeism. Am J Infect Control. 2019 May;47(5):498-503. doi: 10.1016/j.ajic.2018.11.014. Epub 2019 Jan 4.
PubMed 30612818Sarwar S, Muhammad J, Shahzad F. A modified hand washing method for resource limited settings. Front Public Health. 2022 Aug 4;10:965853. doi: 10.3389/fpubh.2022.965853. eCollection 2022.
PubMed 35991070
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE IMPACT OF HAND HYGIENE INTERVENTION ON HEALTH OUTCOMES AND SCHOOL ABSENTEEISM AMONG BASIC SCHOOL CHILDREN IN ERBIL CITY
- ClinicalTrials.gov ID
- NCT07467902
- Acronym / sponsor ID
- Hand hygiene / HMU nursing college
- Keywords
- Handwashing Hand hygiene School health Respiratory infections Gastrointestinal infections School absenteeism Cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Hawler Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand Hygiene Intervention Group | Experimental | Behavioral: Hand Hygiene Education ProgramStudents 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. |
| (Control Group) | No intervention | –Students in this group continue their regular school routine without receiving the structured hand hygiene education program during the study period. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Hygiene Education ProgramModified 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. | Behavioural | Hand Hygiene Intervention Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 31324487Mbakaya BC, Lee P, Lee RLT. Effect of a school-based hand hygiene program for Malawian children: A cluster randomized controlled trial. Am J Infect Control. 2019 Dec;47(12):1460-1464. doi: 10.1016/j.ajic.2019.06.009. Epub 2019 Jul 16.
- Background: PubMed 30612818Or PPL, Ching PTY, Chung JWY. A program to improve the hand hygiene compliance of Hong Kong preschoolers with an insight into their absenteeism. Am J Infect Control. 2019 May;47(5):498-503. doi: 10.1016/j.ajic.2018.11.014. Epub 2019 Jan 4.
- Background: PubMed 35991070Sarwar S, Muhammad J, Shahzad F. A modified hand washing method for resource limited settings. Front Public Health. 2022 Aug 4;10:965853. doi: 10.3389/fpubh.2022.965853. eCollection 2022.
- college of nursing siteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazar pols Shabila, Professor study director
Hawler Medical University/College of nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Hygiene Education Program in people with Respiratory Disease and Gastrointestinal Diseases and Symptom, run by Hawler Medical University at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467902, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.