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- Klinische proef NCT07654673
Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children
12 juni 2026 bijgewerkt door: Aynur Aytekin Ozdemir, Istanbul Medeniyet University
Determination of the Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children: A Cluster Randomized Controlled Trial
This study aimed to determine the effectiveness of a play-based nasal hygiene education program on nasal hygiene knowledge and skills among preschool children.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
This completed cluster randomized controlled trial evaluated the effectiveness of a play-based nasal hygiene education program on nasal hygiene knowledge and skills among preschool children.
The study was conducted in the kindergarten level of a public primary school in Istanbul, Türkiye.
Two preschool classrooms were randomly assigned to the intervention and control groups.
The intervention group received a structured nasal hygiene education program including visual educational materials, an animation-based video, and play-based skill practice activities, while the control group received no education during the data collection period.
Outcomes were assessed at baseline and two weeks after completion of the intervention using performance-based and video-recorded assessments.
After post-test measurements, the education program was also provided to the control group.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Istanbul, Turkije (Türkiye)
- Istanbul Medeniyet University
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusion Criteria:
- Being enrolled in the preschool/kindergarten class of the school where the study was conducted
- Being able to speak and understand Turkish
- Having written informed consent from a parent or legal guardian
- Being willing to participate in the study
Exclusion Criteria:
- Having an active disease that could affect nasal hygiene practice during data collection
- Having any chronic disease
- Having structural anomalies that may cause nasal obstruction
- Having a physical or cognitive impairment that prevents communication, watching the educational materials, or completing the measurement tools
- Having previously participated in a structured education program on nasal hygiene or nose-blowing skills
- Not having written informed consent from a parent or legal guardian
- Not being willing to participate in the study
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Play-Based Nasal Hygiene Education Group
Participants in the intervention group received a structured play-based nasal hygiene education program designed for preschool children.
The program included visual educational materials, an animation-based educational video, and play-based skill development activities.
The intervention aimed to improve children's nasal hygiene knowledge and performance, and hand hygiene after nasal cleaning.
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The intervention consisted of a structured nasal hygiene education program developed for preschool children.
The program included group-based education using visual educational materials, an animation-based educational video, and demonstration of nasal hygiene steps.
It also included individual play-based practice stations: nasal air pressure development activities, nasal airflow performance activities, nasal hygiene sequencing cards, and a simulated nasal hygiene practice station.
The program targeted both cognitive learning and psychomotor skill development.
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Geen tussenkomst: Control Group
Participants in the control group did not receive any nasal hygiene education during the data collection period.
After completion of the post-test measurements, the nasal hygiene education program was also provided to the control group.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Nasal Hygiene Knowledge Score
Tijdsspanne: Baseline and two weeks after completion of the intervention
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Children's nasal hygiene knowledge was assessed using the Nasal Hygiene Knowledge Sequencing Test.
The test consists of eight visual cards representing the steps of nasal hygiene.
Children were asked to place the cards in the correct order.
Each correctly ordered card was scored as 1 point and each incorrectly ordered card was scored as 0 points.
Higher scores indicate a higher level of nasal hygiene knowledge.
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Baseline and two weeks after completion of the intervention
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Change in Nasal Air Pressure Performance
Tijdsspanne: Baseline and two weeks after completion of the intervention
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Nasal air pressure performance was assessed using the Nasal Air Pressure Measurement Test.
A lightweight paper strip was fixed to the child's nasal bridge, and the child was asked to blow through the nose with the mouth closed.
Performance was evaluated based on the angle difference between the baseline position of the paper and the maximum elevation angle achieved during nasal blowing.
Higher angle differences indicate better nasal air pressure performance.
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Baseline and two weeks after completion of the intervention
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Change in Nasal Airflow Performance
Tijdsspanne: Baseline and two weeks after completion of the intervention
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Nasal airflow performance was assessed using the Nasal Airflow Performance Test.
A lightweight pom-pom ball was placed inside a cardboard tube attached to a pediatric respiratory mask.
Children were asked to blow through the nose with the mouth closed to move the pom-pom out of the tube.
Performance was evaluated using two parameters: success in expelling the pom-pom from the tube and the time required to expel the pom-pom.
Successful expulsion and shorter completion time indicate better nasal airflow performance.
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Baseline and two weeks after completion of the intervention
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Change in Nasal Hygiene Skill Score
Tijdsspanne: Baseline and two weeks after completion of the intervention
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Children's nasal hygiene skills were assessed using the Nasal Hygiene Skill Assessment Checklist.
The checklist evaluates children's performance of nasal hygiene steps in a simulated environment.
Each skill step was scored as "performed" = 3 points, "partially performed" = 2 points, and "not performed" = 1 point.
Higher scores indicate better nasal hygiene skill performance.
The performance was video-recorded and evaluated by independent observers.
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Baseline and two weeks after completion of the intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Parent-Rated Independent Nasal Hygiene Performance
Tijdsspanne: Baseline and four weeks after completion of the intervention
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Parents evaluated children's independent nasal hygiene performance using a visual analog scale.
Higher scores indicate a higher level of independent nasal hygiene performance.
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Baseline and four weeks after completion of the intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 november 2025
Primaire voltooiing (Werkelijk)
16 januari 2026
Studie voltooiing (Werkelijk)
16 januari 2026
Studieregistratiedata
Eerst ingediend
12 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
12 juni 2026
Eerst geplaatst (Werkelijk)
17 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
12 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2025/020-14
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
Individual participant data will not be shared due to the involvement of child participants, video-recorded performance assessments, and confidentiality restrictions.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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