- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07654673
Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children
12. juni 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Istanbul, Tyrkia (Türkiye)
- Istanbul Medeniyet University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Nasal Hygiene Knowledge Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Parent-Rated Independent Nasal Hygiene Performance
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. november 2025
Primær fullføring (Faktiske)
16. januar 2026
Studiet fullført (Faktiske)
16. januar 2026
Datoer for studieregistrering
Først innsendt
12. juni 2026
Først innsendt som oppfylte QC-kriteriene
12. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025/020-14
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Individual participant data will not be shared due to the involvement of child participants, video-recorded performance assessments, and confidentiality restrictions.
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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