- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07654673
Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children
12. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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-
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Istanbul, Türkei (türkiye)
- Istanbul Medeniyet University
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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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Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Nasal Hygiene Knowledge Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Parent-Rated Independent Nasal Hygiene Performance
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. November 2025
Primärer Abschluss (Tatsächlich)
16. Januar 2026
Studienabschluss (Tatsächlich)
16. Januar 2026
Studienanmeldedaten
Zuerst eingereicht
12. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. Juni 2026
Zuerst gepostet (Tatsächlich)
17. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025/020-14
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
Individual participant data will not be shared due to the involvement of child participants, video-recorded performance assessments, and confidentiality restrictions.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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