NCT07654673

Brief Summary

This study aimed to determine the effectiveness of a play-based nasal hygiene education program on nasal hygiene knowledge and skills among preschool children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2026

Completed
Last Updated

June 17, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 12, 2026

Last Update Submit

June 12, 2026

Conditions

Keywords

Nasal hygieneNose blowingPreschool childrenPlay-based educationHealth educationCluster randomized controlled trial

Outcome Measures

Primary Outcomes (4)

  • Change in Nasal Hygiene Knowledge Score

    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

    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

    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

    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

Secondary Outcomes (1)

  • Change in Parent-Rated Independent Nasal Hygiene Performance

    Baseline and four weeks after completion of the intervention

Study Arms (2)

Play-Based Nasal Hygiene Education Group

EXPERIMENTAL

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.

Behavioral: Play-Based Nasal Hygiene Education Program

Control Group

NO INTERVENTION

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.

Interventions

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.

Play-Based Nasal Hygiene Education Group

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health BehaviorHealth Education

Condition Hierarchy (Ancestors)

BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Officials

  • Aynur Aytekin Özdemir, Professor

    İstanbul Medeniyet University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Due to the nature of the educational and play-based intervention, participants and the researcher delivering the intervention could not be blinded. However, performance-based assessments were video-recorded and evaluated by independent observers to reduce measurement bias.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study used a cluster randomized parallel-group design. Randomization was conducted at the classroom level to reduce the risk of contamination between children.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 12, 2026

First Posted

June 17, 2026

Study Start

November 1, 2025

Primary Completion

January 16, 2026

Study Completion

January 16, 2026

Last Updated

June 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to the involvement of child participants, video-recorded performance assessments, and confidentiality restrictions.

Locations