Nasal HygieneNCT07654673
Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children
A study testing Play-Based Nasal Hygiene Education Program in people with Nasal Hygiene and Respiratory Tract Infection Prevention, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Hygiene, Respiratory Tract Infection Prevention, Health Behavior
- What is being tested?
- Play-Based Nasal Hygiene Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2025to 16 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasal Hygiene, Respiratory Tract Infection Prevention, Health Behavior, Preschool Children
- Being tested
- Play-Based Nasal Hygiene Education Program
- Keywords
- Nasal hygiene, Nose blowing, Preschool children, Play-based education, Health education, Cluster randomized controlled trial
- Medical subject headings
- Health Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Play-Based Nasal Hygiene Education ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and two weeks after completion of the intervention
Secondary outcomes (1)
Change in Parent-Rated Independent Nasal Hygiene Performance
Parents evaluated children's independent nasal hygiene performance using a visual analog scale. Higher scores indicate a higher level of independent nasal hygiene performance.
Measured: Baseline and four weeks after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Nov 2025
- Primary completion16 Jan 2026
- Study completion16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a cluster randomized parallel-group design. Randomization was conducted at the classroom level to reduce the risk of contamination between children.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Aytekin Ozdemir, Istanbul Medeniyet University
- Investigators
- Aynur Aytekin Özdemir, Professor, Principal investigator, İstanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654673
- Sponsor's protocol ID
- 2025/020-14
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the involvement of child participants, video-recorded performance assessments, and confidentiality restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effectiveness of Play-Based Nasal Hygiene Education in Preschool Children: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07654673
- Acronym / sponsor ID
- 2025/020-14
- Conditions
- Nasal Hygiene, Respiratory Tract Infection Prevention, Health Behavior, Preschool Children
- Keywords
- Nasal hygiene, Nose blowing, Preschool children, Play-based education, Health education, Cluster randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 16 Jan 2026 (actual)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine the effectiveness of a play-based nasal hygiene education program on nasal hygiene knowledge and skills among preschool children.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a cluster randomized parallel-group design. Randomization was conducted at the classroom level to reduce the risk of contamination between children.
| Arm | Type | Receives |
|---|---|---|
| Play-Based Nasal Hygiene Education Group | Experimental | Behavioral: Play-Based Nasal Hygiene Education ProgramParticipants 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. |
| 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. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Play-Based Nasal Hygiene Education ProgramThe 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. | Behavioural | Play-Based Nasal Hygiene Education Group |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Change in Parent-Rated Independent Nasal Hygiene Performance
Time frame: Baseline and four weeks after completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the involvement of child participants, video-recorded performance assessments, and confidentiality restrictions.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aynur Aytekin Özdemir, Professor principal investigator
İstanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Play-Based Nasal Hygiene Education Program in people with Nasal Hygiene and Respiratory Tract Infection Prevention, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Nasal Hygiene Knowledge Score (time frame: Baseline and two weeks after completion of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.