Respiratory Tract; Infection, Upper (Acute)NCT04267952
Hand Hygiene Intervention Program on Primary School Students' Health Outcomes and Absenteeism in School
A study testing Hand hygiene intervention program developed according to planned behavior theory and Classical hand hygiene education in people with Respiratory Tract; Infection, Upper (Acute) and Hand Hygiene, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The most common infections in schools are acute respiratory infections (colds, pharyngitis, influenza and others) and diarrheal diseases. The incidence of these infections may also be an important cause of school absenteeism, leading to negative outcomes in both education and health. Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract; Infection, Upper (Acute), Hand Hygiene, Absenteeism
- What is being tested?
- Hand hygiene intervention program developed according to planned behavior theory and Classical hand hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2019to 29 Jun 2020
- 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 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- primary school student (especially third and fourth class student)
Who cannot join
- people with chronic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Theory of Planned Behaviour Based Hand Hygiene Intervention Program on Primary School Students' Health Outcomes and Absenteeism in School
The most common infections in schools are acute respiratory infections (colds, pharyngitis, influenza and others) and diarrheal diseases. The incidence of these infections may also be an important cause of school absenteeism, leading to negative outcomes in both education and health.
WHO states that handwashing a well-known primary infection control measure, is the most important hygiene measure to prevent the spread of infection when handwashing is done with soap and water. Since behavioral choices that determine lifestyle are made in childhood, it is important that health education in hand hygiene be implemented as early as possible to improve healthy behaviors. In this context, schools are important structures for information and behavior change about water, sanitation and hygiene interventions.
Read more
Planned Behavior Theory (PBT) states that intention is the main precursor of behavior. According to the theory, intention is guided by three independent variables (perceived behavior control, attitudes and subjective norms), and intention formation leads to the development of behavior. The theory has been used in a study to improve hand hygiene behavior in health workers, but it has not been used in the literature to improve hygiene behaviors in children.
Researches indicate that students who do not attend school frequently or for a long time have difficulty in mastering the subject described in the lesson and that school absenteeism is an issue that should be emphasized in education. Therefore, hand hygiene has a simultaneous effect that improves both education and health and contributes to a safe and healthy learning environment. The aim of this research is; To test the effect of hand hygiene intervention program based on Planned Behavior Theory on students' health outcomes and school absenteeism.
Read the detailed description
The most common infections in schools are acute respiratory infections (colds, pharyngitis, influenza and others) and diarrheal diseases. Acute respiratory infections are a major cause of morbidity and mortality in children and a major public health problem in both developed and developing countries. The incidence of these infections may also be an important cause of school absenteeism, leading to negative outcomes in both education and health.
Improving water, sanitation and hygiene in schools is an important intervention for the healthy development of children. WHO states that handwashing a well-known primary infection control measure, is the most important hygiene measure to prevent the spread of infection when handwashing is done with soap and water. It was found that well-structured and applied handwashing techniques were useful in reducing the incidence of gastro-intestinal and respiratory infections in school children; handwashing with soap reduces respiratory infections in children by 16% - 25%.
In children, unlike adults, it is more likely to give positive behavior because negative hygiene habits are less established and do not have stereotyped and difficult to change habits. Since behavioral choices that determine lifestyle are made in childhood, it is important that health education in hand hygiene be implemented as early as possible to improve healthy behaviors. In this context, schools are important structures for information and behavior change about water, sanitation and hygiene interventions. Hand hygiene initiatives in the school provide multiple gains by enabling children to become hygienic ambassadors in their own homes and gaining the skills they can sustain during the adult period.
Planned Behavior Theory (PBT) states that intention is the main precursor of behavior.
According to the theory, intention is guided by three independent variables (perceived behavior control, attitudes and subjective norms), and intention formation leads to the development of behavior. In a systematic review of 30 studies using PBT in various health interventions, two thirds of studies reported effective behavior change. The theory has been used in a study to improve hand hygiene behavior in health workers, but it has not been used in the literature to improve hygiene behaviors in children.
Researches indicate that students who do not attend school frequently or for a long time have difficulty in mastering the subject described in the lesson and that school absenteeism is an issue that should be emphasized in education. Therefore, hand hygiene has a simultaneous effect that improves both education and health and contributes to a safe and healthy learning environment. The aim of this research is; To test the effect of hand hygiene intervention program based on Planned Behavior Theory on students' health outcomes and school absenteeism.
- Being tested
- Hand hygiene intervention program developed according to planned behavior theory, Classical hand hygiene education
- Keywords
- Health education, Theory of planned behavior, Primary schools
- Medical subject headings
- Infections, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand hygiene intervention program developed according to planned behavior theoryBehavioural
The perception of the importance of hand hygiene with expression of damages of microorganisms (stories about illnesses etc.). Visually assisted hand hygiene training experiments to ensure the visibility of microorganisms in the environment. Demonstration and application of the correct hand washing technique with music. All applications will take place in three lessons (120-minute).
Classical hand hygiene educationBehavioural
expression of hand hygiene with verbal presentation method in a 40-minute lecture
| Study group | Role | What they receive |
|---|---|---|
| first group | Experimental | Hand hygiene intervention program prepared by using planned behavior theory will be applied to the students in this group. Receives: Behavioral: Hand hygiene intervention program developed according to planned behavior theory |
| second group | Active comparator | Students in this group will be given classic hand hygiene training Receives: Behavioral: Classical hand hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group A Streptekok infections in rapid antigen test
Children with symptoms of infection will be referred to the family physician to have a rapid antigen test and to report the result to the researcher.
Measured: Total 20 weeks
Incidence of symptoms of acute upper respiratory tract infection
Ten identified upper respiratory tract symptoms (fever, sore throat, runny nose, etc.) will be recorded weekly by family of children. The researcher will receive symptom information from the family via weekly sms
Measured: Total 20 weeks
school absenteeism
The number of days the child does not attend school due to illness and the percentage of absenteeism
Measured: Total 20 weeks
Secondary outcomes (1)
Pollution rate of hands
Glogerm gel applied hands will shine areas containing microorganisms. Contamination rate will be calculated by taking the photo of the hands and performing brightness analysis in adobe photoshop program.
Measured: From date of randomization until the date of first documented progression assessed up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start9 Sep 2019
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract; Infection, Upper (Acute)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulcin Uyanık, Izmir Katip Celebi University
- Investigators
- Şafak Dağhan, Study director, Ege University, Nursing Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267952
- Sponsor's protocol ID
- 509055
- Status last verified
- Jul 2020
- First submitted
- 21 Dec 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tai JW, Mok ES, Ching PT, Seto WH, Pittet D. Nurses and physicians' perceptions of the importance and impact of healthcare-associated infections and hand hygiene: a multi-center exploratory study in Hong Kong. Infection. 2009 Aug;37(4):320-33. doi: 10.1007/s15010-009-8245-x. Epub 2009 Jul 27.
PubMed 19636497
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Theory of Planned Behaviour Based Hand Hygiene Intervention Program on Primary School Students' Health Outcomes and Absenteeism in School
- ClinicalTrials.gov ID
- NCT04267952
- Acronym / sponsor ID
- 509055
- Keywords
- Health education, Theory of planned behavior, Primary schools
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 13 Feb 2020 (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 most common infections in schools are acute respiratory infections (colds, pharyngitis, influenza and others) and diarrheal diseases. The incidence of these infections may also be an important cause of school absenteeism, leading to negative outcomes in both education and health.
WHO states that handwashing a well-known primary infection control measure, is the most important hygiene measure to prevent the spread of infection when handwashing is done with soap and water. Since behavioral choices that determine lifestyle are made in childhood, it is important that health education in hand hygiene be implemented as early as possible to improve healthy behaviors. In this context, schools are important structures for information and behavior change about water, sanitation and hygiene interventions.
Planned Behavior Theory (PBT) states that intention is the main precursor of behavior. According to the theory, intention is guided by three independent variables (perceived behavior control, attitudes and subjective norms), and intention formation leads to the development of behavior. The theory has been used in a study to improve hand hygiene behavior in health workers, but it has not been used in the literature to improve hygiene behaviors in children.
Researches indicate that students who do not attend school frequently or for a long time have difficulty in mastering the subject described in the lesson and that school absenteeism is an issue that should be emphasized in education. Therefore, hand hygiene has a simultaneous effect that improves both education and health and contributes to a safe and healthy learning environment. The aim of this research is; To test the effect of hand hygiene intervention program based on Planned Behavior Theory on students' health outcomes and school absenteeism.
Detailed description
The most common infections in schools are acute respiratory infections (colds, pharyngitis, influenza and others) and diarrheal diseases. Acute respiratory infections are a major cause of morbidity and mortality in children and a major public health problem in both developed and developing countries. The incidence of these infections may also be an important cause of school absenteeism, leading to negative outcomes in both education and health.
Improving water, sanitation and hygiene in schools is an important intervention for the healthy development of children. WHO states that handwashing a well-known primary infection control measure, is the most important hygiene measure to prevent the spread of infection when handwashing is done with soap and water. It was found that well-structured and applied handwashing techniques were useful in reducing the incidence of gastro-intestinal and respiratory infections in school children; handwashing with soap reduces respiratory infections in children by 16% - 25%.
In children, unlike adults, it is more likely to give positive behavior because negative hygiene habits are less established and do not have stereotyped and difficult to change habits. Since behavioral choices that determine lifestyle are made in childhood, it is important that health education in hand hygiene be implemented as early as possible to improve healthy behaviors. In this context, schools are important structures for information and behavior change about water, sanitation and hygiene interventions. Hand hygiene initiatives in the school provide multiple gains by enabling children to become hygienic ambassadors in their own homes and gaining the skills they can sustain during the adult period.
Planned Behavior Theory (PBT) states that intention is the main precursor of behavior.
According to the theory, intention is guided by three independent variables (perceived behavior control, attitudes and subjective norms), and intention formation leads to the development of behavior. In a systematic review of 30 studies using PBT in various health interventions, two thirds of studies reported effective behavior change. The theory has been used in a study to improve hand hygiene behavior in health workers, but it has not been used in the literature to improve hygiene behaviors in children.
Researches indicate that students who do not attend school frequently or for a long time have difficulty in mastering the subject described in the lesson and that school absenteeism is an issue that should be emphasized in education. Therefore, hand hygiene has a simultaneous effect that improves both education and health and contributes to a safe and healthy learning environment. The aim of this research is; To test the effect of hand hygiene intervention program based on Planned Behavior Theory on students' health outcomes and school absenteeism.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group | Experimental | Behavioral: Hand hygiene intervention program developed according to planned behavior theoryHand hygiene intervention program prepared by using planned behavior theory will be applied to the students in this group. |
| second group | Active comparator | Behavioral: Classical hand hygiene educationStudents in this group will be given classic hand hygiene training |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- primary school student (especially third and fourth class student)
Key exclusion criteria (1 listed)
- people with chronic disease
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 intervention program developed according to planned behavior theoryThe perception of the importance of hand hygiene with expression of damages of microorganisms (stories about illnesses etc.). Visually assisted hand hygiene training experiments to ensure the visibility of microorganisms in the environment. Demonstration and application of the correct hand washing technique with music. All applications will take place in three lessons (120-minute). | Behavioural | first group |
| Classical hand hygiene educationexpression of hand hygiene with verbal presentation method in a 40-minute lecture | Behavioural | second group |
Primary outcome
Group A Streptekok infections in rapid antigen test
Time frame: Total 20 weeks
Children with symptoms of infection will be referred to the family physician to have a rapid antigen test and to report the result to the researcher.
Incidence of symptoms of acute upper respiratory tract infection
Time frame: Total 20 weeks
Ten identified upper respiratory tract symptoms (fever, sore throat, runny nose, etc.) will be recorded weekly by family of children. The researcher will receive symptom information from the family via weekly sms
school absenteeism
Time frame: Total 20 weeks
The number of days the child does not attend school due to illness and the percentage of absenteeism
1 secondary outcome
Pollution rate of hands
Time frame: From date of randomization until the date of first documented progression assessed up to 7 months
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 29 Jul 2020.
- Background: PubMed 19636497Tai JW, Mok ES, Ching PT, Seto WH, Pittet D. Nurses and physicians' perceptions of the importance and impact of healthcare-associated infections and hand hygiene: a multi-center exploratory study in Hong Kong. Infection. 2009 Aug;37(4):320-33. doi: 10.1007/s15010-009-8245-x. Epub 2009 Jul 27.
- 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.
Şafak Dağhan study director
Ege University, Nursing Faculty
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 intervention program developed according to planned behavior theory and Classical hand hygiene education in people with Respiratory Tract; Infection, Upper (Acute) and Hand Hygiene, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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 29 Jul 2020. 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 Turkey (Türkiye). 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?
Group A Streptekok infections in rapid antigen test (time frame: Total 20 weeks). The study lists 3 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 NCT04267952, which also lists 1 linked publication.
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 29 Jul 2020.