- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07654673
Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children
12 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Istanbul, Turchia (Türkiye)
- Istanbul Medeniyet University
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
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.
|
|
Nessun intervento: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Nasal Hygiene Knowledge Score
Lasso di tempo: Baseline and two weeks after completion of the intervention
|
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.
|
Baseline and two weeks after completion of the intervention
|
|
Change in Nasal Air Pressure Performance
Lasso di tempo: Baseline and two weeks after completion of the intervention
|
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.
|
Baseline and two weeks after completion of the intervention
|
|
Change in Nasal Airflow Performance
Lasso di tempo: Baseline and two weeks after completion of the intervention
|
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.
|
Baseline and two weeks after completion of the intervention
|
|
Change in Nasal Hygiene Skill Score
Lasso di tempo: Baseline and two weeks after completion of the intervention
|
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.
|
Baseline and two weeks after completion of the intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Parent-Rated Independent Nasal Hygiene Performance
Lasso di tempo: Baseline and four weeks after completion of the intervention
|
Parents evaluated children's independent nasal hygiene performance using a visual analog scale.
Higher scores indicate a higher level of independent nasal hygiene performance.
|
Baseline and four weeks after completion of the intervention
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 novembre 2025
Completamento primario (Effettivo)
16 gennaio 2026
Completamento dello studio (Effettivo)
16 gennaio 2026
Date di iscrizione allo studio
Primo inviato
12 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
12 giugno 2026
Primo Inserito (Effettivo)
17 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
17 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
12 giugno 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2025/020-14
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
Individual participant data will not be shared due to the involvement of child participants, video-recorded performance assessments, and confidentiality restrictions.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Comportamento sanitario
-
University of Dublin, Trinity CollegeSconosciutoBrain Health Atleti d'élite in pensione
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... e altri collaboratoriNon ancora reclutamentoUn intervento formativo sulla comunicazione vaccinale per i medici del reparto pediatrico (PIVOT-IN)Servizi Sanitari Preventivi (PREV HEALTH SERV)Stati Uniti
-
University of MacauReclutamentoAlfabetizzazione sanitaria | Alfabetizzazione Alimentare | Alfabetizzazione mediatica | E-Health AlfabetizzazioneMacao
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... e altri collaboratoriCompletatoServizi Sanitari Preventivi (PREV HEALTH SERV)Stati Uniti
-
King's College LondonSouth London and Maudsley NHS Foundation TrustIscrizione su invitoDetenzione in base al Mental Health ActRegno Unito
-
The Hospital for Sick ChildrenBill and Melinda Gates Foundation; Aga Khan UniversityAttivo, non reclutanteUnder Five Child Health Nutrizione e immunizzazionePakistan
-
Queens College, The City University of New YorkReclutamentoPubblicazione di articoli sottoposti all'American Journal of Public HealthStati Uniti
-
KTO Karatay UniversityCompletatoComportamenti di stile di vita sani | E-Health AlfabetizzazioneTacchino
-
Kliniek ViaSanaSt. Anna Ziekenhuis, Geldrop, NetherlandsCompletatoDolore | Uso di oppioidi | Sostituzione totale del ginocchio | App E-healthOlanda
-
Brown UniversityJohns Hopkins University; University of Arkansas; Anhui Medical UniversityCompletato