Upper Respiratory Tract InfectionsNCT03535064
The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to URIs in Riyadh City, 2017-2018.
A study testing Hand Hygiene Workshop in people with Upper Respiratory Tract Infections, run by Abrar Alzaher at 1 site in Saudi Arabia.
Trial summary
Research Problem: Upper respiratory infections (URIs) are a common reason for absence from schools as it is estimated that children get six to eight episodes every year. In Jazan (2013-2014), 34% of primary health care centre attendees who were complaining of URIs were under 15 years old and 42% of them were positive… Read more about this study
- Who is it for?
- Ages 6 to 12 years, women only
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- Hand Hygiene Workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Jan 2018to 1 Sep 2018
- 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 6 to 12 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- All schoolgirls attended randomly selected schools
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to Upper Respiratory Infections (URIs) in Riyadh City, 2017-2018. A Cluster Randomized Trial
Research Problem:
Upper respiratory infections (URIs) are a common reason for absence from schools as it is estimated that children get six to eight episodes every year. In Jazan (2013-2014), 34% of primary health care centre attendees who were complaining of URIs were under 15 years old and 42% of them were positive when tested for viruses by nasopharyngeal swabs. An intervention for URIs prevention is hand hygiene, as it has been shown to have an impact on reducing the risk of respiratory infections by 50% among children in Karachi, Pakistan by encouraging hand washing with soap. Another randomised controlled trial study conducted in Spain among primary school students showed a statistically significant 38% reduction in the absenteeism rate due to URIs in the intervention group who received education about hand hygiene and used hand sanitisers which were distributed among schools. Also, the Chinese conducted a cluster randomised control trial evaluating the effect of a hand washing programme and revealed a 38% reduction in absence due to URIs among primary schoolchildren.
Read more
This preventive measure is questionable, as a randomised controlled trial done among primary school students in New Zealand revealed that encouraging the use of hand sanitisers in schools did not have an impact on reducing acute respiratory infections or absenteeism. The questionable effect was also documented in a systematic review and meta-analysis for randomised controlled trials about the effectiveness of hand hygiene in decreasing absences through illness in educational settings.
Research Significance:
Appropriate hand hygiene is recommended as a non-pharmacological preventive measure against respiratory infections. But this preventive measure is questionable as the results of randomised controlled trials about the effectiveness of different hand hygiene interventions in reducing absence due to upper respiratory tract infection in different educational settings are controversial. Furthermore, previous studies of hand hygiene interventions were low in quality and it is recommended to improve future studies relating to it. Also, there is no research on the effectiveness of these measures in Saudi Arabia. So, this piece will add new knowledge to local and international literature. In addition, this study may help the school health administration to develop a hand hygiene programme.
Objectives:
- To determine if hand hygiene education is associated with school absence rates due to URIs reduction among primary schoolgirls in Riyadh city, 2017-2018
- To measure post-intervention total primary schoolgirl's absence rate (both groups) in Riyadh city, 2017-2018.
- To measure post-intervention primary schoolgirls' absence rate due to upper respiratory infections (both groups) in Riyadh city, 2017-2018.
Methodology:
Cluster RCT will be conducted among primary schoolgirls attending public schools in Riyadh city in the first education semester. Sampling will be multistage to end up with four schools. 616 schoolgirls who are attending the selected classes will be invited to the study. Two schools will be randomly assigned to the intervention, which includes one-hour hand washing workshop at the beginning of the study, in addition to posters. Parents will self-administer the questionnaire at baseline, in addition to a follow-up phone interview questionnaire.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- Hand Hygiene Workshop
- Keywords
- HAND HYGIENE, HAND WASHING, INFLUENZA, SCHOOL ABSENCE, SCHOOL CHILDREN, UPPER RESPIRATORY INFECTIONS
- Medical subject headings
- Respiratory Tract Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Hygiene WorkshopOther
Workshops included video-clip and interactive lecture about common infections in schools, methods of transmission, and hand washing procedure and time. Puzzle games related to hand hygiene were distributed among schoolgirls. Posters with cartoon princess picture promote for hand hygiene were also distributed among the schools.
| Study group | Role | What they receive |
|---|---|---|
| Schools received hand hygiene workshop | Experimental | Schoolgirls of randomly assigned schools attended one-hour Arabic handwashing workshop conducted by the principal investigator one week after submitting all baseline questionnaires. Workshops included video-clip and interactive lecture about common infections in schools, methods of transmission, and hand washing procedure and time. Puzzle games related to hand hygiene were distributed among schoolgirls. Posters with cartoon princess picture promote for hand hygiene were also distributed among the schools. Receives: Other: Hand Hygiene Workshop |
| Schools with did not receive hand hygiene workshop | No intervention | Schoolgirls in control group followed their usual hand washing procedure. When the study ended, schoolgirls of control school were exposed to the same intervention by the same investigator. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary schoolgirls absence due to URIs
Absence was collected from schools and parents were called to fill follow up questionnaire
Measured: five weeks
Secondary outcomes (1)
Total Primary schoolgirls absence
Absence was collected from schools
Measured: five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2018
- Study start28 Jan 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies 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
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abrar Alzaher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abrar Alzaher, King Saud University
- Investigators
- Abrar A Alzaher, MD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03535064
- Sponsor's protocol ID
- E-17-2523
- Status last verified
- Feb 2019
- First submitted
- 12 May 2018
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association of Hand Hygiene Practice on Primary Schoolgirls Absence Due to Upper Respiratory Infections (URIs) in Riyadh City, 2017-2018. A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03535064
- Acronym / sponsor ID
- E-17-2523
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- HAND HYGIENE, HAND WASHING, INFLUENZA, SCHOOL ABSENCE, SCHOOL CHILDREN, UPPER RESPIRATORY INFECTIONS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Abrar AlzaherUniversity, hospital or other
- Study start
- 28 Jan 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 24 May 2018 (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.
Research Problem:
Upper respiratory infections (URIs) are a common reason for absence from schools as it is estimated that children get six to eight episodes every year. In Jazan (2013-2014), 34% of primary health care centre attendees who were complaining of URIs were under 15 years old and 42% of them were positive when tested for viruses by nasopharyngeal swabs. An intervention for URIs prevention is hand hygiene, as it has been shown to have an impact on reducing the risk of respiratory infections by 50% among children in Karachi, Pakistan by encouraging hand washing with soap. Another randomised controlled trial study conducted in Spain among primary school students showed a statistically significant 38% reduction in the absenteeism rate due to URIs in the intervention group who received education about hand hygiene and used hand sanitisers which were distributed among schools. Also, the Chinese conducted a cluster randomised control trial evaluating the effect of a hand washing programme and revealed a 38% reduction in absence due to URIs among primary schoolchildren.
This preventive measure is questionable, as a randomised controlled trial done among primary school students in New Zealand revealed that encouraging the use of hand sanitisers in schools did not have an impact on reducing acute respiratory infections or absenteeism. The questionable effect was also documented in a systematic review and meta-analysis for randomised controlled trials about the effectiveness of hand hygiene in decreasing absences through illness in educational settings.
Research Significance:
Appropriate hand hygiene is recommended as a non-pharmacological preventive measure against respiratory infections. But this preventive measure is questionable as the results of randomised controlled trials about the effectiveness of different hand hygiene interventions in reducing absence due to upper respiratory tract infection in different educational settings are controversial. Furthermore, previous studies of hand hygiene interventions were low in quality and it is recommended to improve future studies relating to it. Also, there is no research on the effectiveness of these measures in Saudi Arabia. So, this piece will add new knowledge to local and international literature. In addition, this study may help the school health administration to develop a hand hygiene programme.
Objectives:
- To determine if hand hygiene education is associated with school absence rates due to URIs reduction among primary schoolgirls in Riyadh city, 2017-2018
- To measure post-intervention total primary schoolgirl's absence rate (both groups) in Riyadh city, 2017-2018.
- To measure post-intervention primary schoolgirls' absence rate due to upper respiratory infections (both groups) in Riyadh city, 2017-2018.
Methodology:
Cluster RCT will be conducted among primary schoolgirls attending public schools in Riyadh city in the first education semester. Sampling will be multistage to end up with four schools. 616 schoolgirls who are attending the selected classes will be invited to the study. Two schools will be randomly assigned to the intervention, which includes one-hour hand washing workshop at the beginning of the study, in addition to posters. Parents will self-administer the questionnaire at baseline, in addition to a follow-up phone interview questionnaire.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schools received hand hygiene workshop | Experimental | Other: Hand Hygiene WorkshopSchoolgirls of randomly assigned schools attended one-hour Arabic handwashing workshop conducted by the principal investigator one week after submitting all baseline questionnaires. Workshops included video-clip and interactive lecture about common infections in schools, methods of transmission, and hand washing procedure and time. Puzzle games related to hand hygiene were distributed among schoolgirls. Posters with cartoon princess picture promote for hand hygiene were also distributed among the schools. |
| Schools with did not receive hand hygiene workshop | No intervention | –Schoolgirls in control group followed their usual hand washing procedure. When the study ended, schoolgirls of control school were exposed to the same intervention by the same investigator. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All schoolgirls attended randomly selected schools
Key exclusion criteria (1 listed)
- None
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 WorkshopWorkshops included video-clip and interactive lecture about common infections in schools, methods of transmission, and hand washing procedure and time. Puzzle games related to hand hygiene were distributed among schoolgirls. Posters with cartoon princess picture promote for hand hygiene were also distributed among the schools. | Other | Schools received hand hygiene workshop |
Primary outcome
Primary schoolgirls absence due to URIs
Time frame: five weeks
Absence was collected from schools and parents were called to fill follow up questionnaire
1 secondary outcome
Total Primary schoolgirls absence
Time frame: five weeks
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 1 Mar 2019.
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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.
Abrar A Alzaher, MD principal investigator
King Saud University
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 Workshop in people with Upper Respiratory Tract Infections, run by Abrar Alzaher at 1 site in Saudi Arabia.
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 1 Mar 2019. 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 Saudi Arabia. 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?
Primary schoolgirls absence due to URIs (time frame: five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Mar 2019.