- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07654673
Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children
12 juni 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
40
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Istanbul, Turkiet (Türkiye)
- Istanbul Medeniyet University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Nasal Hygiene Knowledge Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Parent-Rated Independent Nasal Hygiene Performance
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 november 2025
Primärt slutförande (Faktisk)
16 januari 2026
Avslutad studie (Faktisk)
16 januari 2026
Studieregistreringsdatum
Först inskickad
12 juni 2026
Först inskickad som uppfyllde QC-kriterierna
12 juni 2026
Första postat (Faktisk)
17 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025/020-14
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data will not be shared due to the involvement of child participants, video-recorded performance assessments, and confidentiality restrictions.
Läkemedels- och apparatinformation, studiedokument
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Nej
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