Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children

June 12, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Play-Based Nasal Hygiene Education Program
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Nasal Hygiene Knowledge Score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Parent-Rated Independent Nasal Hygiene Performance
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medeniyet University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aynur Aytekin Özdemir, Professor, Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025/020-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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