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Respiratory diseases account for a significant proportion of pediatric emergency department admissions, and effective management of respiratory conditions in children is crucial. Inhaler therapy is commonly used due to its rapid action, non-invasive nature, and ease of administration. However, the effectiveness of inhaler therapy largely depends on correct technique and adherence, particularly among children and their parents. Incorrect inhaler use may worsen clinical outcomes and increase respiratory complications. Educational interventions, including structured and technology-based training, have been shown to improve inhaler technique and treatment effectiveness.
The aim of this study is to evaluate the effectiveness of a mastery learning-based educational program provided to children receiving inhaler therapy and their parents in a pediatric emergency department.
Study Procedure
Phase 1 In the first phase, a validity and reliability study of the Inhaler Therapy Application Checklist, developed to evaluate parents' inhaler administration skills, will be conducted. Validity and reliability data will be collected. After generating the checklist items, the form will be submitted to 10 expert faculty members to evaluate the scientific appropriateness of each item. The Davis technique will be used for expert evaluation. Each item will be rated on a four-point scale as "appropriate," "needs minor revision," "needs major revision," and "not appropriate." Revisions will be made in line with expert feedback, and once all items are considered appropriate, the checklist will be finalized. To determine construct validity, Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA) will be performed.
Phase 2 In the second phase, data will be collected by the researcher between October 2025 and October 2026 from children and parents who meet the study criteria. Parents and children will be informed about the study, and their participation will be requested. Mothers who agree to participate will complete the Informed Consent Form and the Introductory Information Form. Mothers' initial inhaler administration skills in the emergency department will be evaluated by the researcher using the Inhaler Therapy Application Checklist.
In routine hospital education, the placement of the medication into the chamber, positioning of the mask on the face, and operation of the system are explained. Mothers' application skills will be evaluated by the researcher using the Inhaler Therapy Application Checklist during the second inhaler administration following routine nursing education (during the second nebulizer medication administration). Mothers' application skills will be reassessed by the researcher at the 4th-6th hour of hospitalization.
Mothers in the intervention group will receive face-to-face practical training before the procedure using a brochure and the inhaler masks used in the hospital. The brochure will be used as a visual educational material to enhance learning effectiveness. Each step of the procedure will be explained using a return-demonstration method, and mothers will be asked to perform all steps practically. The training sessions are planned to last approximately 15-20 minutes. Mothers will be given the opportunity to ask questions, unclear points will be re-explained, and their deficiencies and mistakes will be discussed based on the provided information. Mothers' inhaler administration skills will be evaluated again by the researcher using the Inhaler Therapy Application Checklist during the subsequent inhaler therapy (during the second inhaled medication administration after training). Anxiety levels of mothers in both groups will be assessed by the researcher after the procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Other | Mothers will receive pre-procedure training using hospital-standard inhaler masks and educational brochures. Each step will be demonstrated and mothers will perform the steps themselves. Training lasts about 15-20 minutes. Practical skills will be evaluated during the second inhaler administration using the Inhaler Treatment Application Checklist. |
|
| Control Group - Routine Care | Other | Parents will be informed about the study. Mothers who agree will complete consent and baseline forms. Initial inhaler administration skills will be evaluated using the Inhaler Treatment Application Checklist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent Education Program | Behavioral | Mothers will receive pre-procedure training using hospital-standard inhaler masks and educational brochures. Each step will be demonstrated, and mothers will perform the steps themselves. Training lasts about 15-20 minutes. Practical skills will be evaluated during the second inhaler administration using the Inhaler Treatment Application Checklist. |
| Measure | Description | Time Frame |
|---|---|---|
| Validity and Reliability Study of the Inhaler Therapy Application Checklist | Outcome Measure Title: Construct Validity of the Inhaler Technique Checklist Description: Construct validity of the Inhaler Technique Checklist will be evaluated using Exploratory Factor Analysis (EFA) and Confirmatory Factor Analysis (CFA). | 12 Month |
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Inclusion Criteria:
Exclusion Criteria:
Refusal to participate in the study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emine Şahin, Phd Student | Contact | +09 (0372) 291 24 82 | e.sahin@sabe.karaelmas.edu.tr | |
| Tülay Kuzlu Ayyıldız, Phd | Contact | +09 (0372) 291 24 82 | tkayyildiz@beun.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Emine Şahin, Phd Student | e.sahin@sabe.karaelmas.edu.tr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| İhsan Doğramacı Children's Hospital | Recruiting | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | • Işık, O., Gül, G., Bol, P., Erbaycu, AE. (2013). Ayakta tedavi gören hastaların inhaler kullanım tekniklerine uyumunun değerlendirilmesi: İnhaler ilaç eğitim birimi uygulaması. Solunum Hastalıkları; 24 (3): 90-94. | ||
| Background | • Çiftçi EK, Aydın D, Karataş H. Cerrahi girişim uygulanacak çocukların ebeveynlerinin endişe nedenleri ve anksiyete durumlarının belirlenmesi. Pediatrik Araştırmalar Derneği 3( 1): 23- 29, 2016. | ||
| Background | • Özçelik, M. (2025). Çocuk acil servise başvuran ebeveynlerde iki farklı yöntem ile verilen nebülizatör eğitiminin etkinliğinin karşılaştırılması: Klasik ve QR kodlu akıllı telefon tabanlı eğitim, Yüksek Lisans Tezi, Zonguldak Bülent Ecevit Üniversitesi Sağlık Bilimleri Enstitüsü, Çocuk Sağlığı ve Hastalıkları Hemşireliği Anabilim Dalı, Zonguldak, 2025. | ||
| 24129338 |
| Label | URL |
|---|---|
| • Shah, RF., Gupta, RM. (2017). Video instruction is more effective than written instruction in improving inhaler technique | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2025 | Mar 1, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 5, 2025 | Mar 1, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Participants are randomly assigned to either the intervention group receiving the parental education program or the control group. The intervention is delivered in the pediatric emergency department
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| Routine Care | Other | Parents will be informed about the study. Mothers who agree will complete consent and baseline forms. Initial inhaler administration skills will be evaluated using the Inhaler Treatment Application Checklist. |
|
| Basheti IA, Bosnic-Anticevich SZ, Armour CL, Reddel HK. Checklists for powder inhaler technique: a review and recommendations. Respir Care. 2014 Jul;59(7):1140-54. doi: 10.4187/respcare.02342. Epub 2013 Oct 15. |
| 26947730 | Result | Carpenter DM, Alexander DS, Elio A, DeWalt D, Lee C, Sleath BL. Using Tailored Videos to Teach Inhaler Technique to Children With Asthma: Results From a School Nurse-Led Pilot Study. J Pediatr Nurs. 2016 Jul-Aug;31(4):380-9. doi: 10.1016/j.pedn.2016.02.005. |
| 38528606 | Result | Goodman K, Arriaga RI, Korman R, Zafar F, Stephens C, Kumari P, Jayaprakash K, Fitzpatrick AM, Cooper N, Morris CR. Pediatric emergency department-based asthma education tools and parent/child asthma knowledge. Allergy Asthma Clin Immunol. 2024 Mar 25;20(1):24. doi: 10.1186/s13223-024-00884-w. |
| D013568 | Pathological Conditions, Signs and Symptoms |