- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07452731
Effectiveness of a Mastery Learning Education Program for Parents of Children Using Inhaler Therapy in an Emergency Unit
Evaluation of the Effectiveness of an Education Program Based on the Mastery Learning Theory for Parents of Children Receiving Inhaler Therapy: A Pediatric Emergency Department Example
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emine Şahin, Phd Student
- Phone Number: +09 (0372) 291 24 82
- Email: e.sahin@sabe.karaelmas.edu.tr
Study Contact Backup
- Name: Tülay Kuzlu Ayyıldız, Phd
- Phone Number: +09 (0372) 291 24 82
- Email: tkayyildiz@beun.edu.tr
Study Locations
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-
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Ankara, Turkey (Türkiye)
- Recruiting
- İhsan Doğramacı Children's Hospital
-
Contact:
- Bulent Ecevit University, Zonguldak Tülay Kuzlu Ayyıldız, Phd
- Phone Number: +90 (0372) 291 24 82
- Email: tkayyildiz@beun.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Child is receiving inhaler medication.
- Child has no intellectual or neurological disability.
- Child has no facial anatomical defects affecting inhaler use.
- Child has no life-threatening conditions.
- Both mother and child can speak Turkish.
- Mother has no communication barriers (e.g., mental capacity intact).
- Mother is literate.
- Voluntary participation in the study
Exclusion Criteria:
Refusal to participate in the study.
- Incomplete data provision.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Intervention Group
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.
|
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.
|
|
Other: Control Group - Routine Care
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Validity and Reliability Study of the Inhaler Therapy Application Checklist
Time Frame: 12 Month
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emine Şahin, Phd Student, e.sahin@sabe.karaelmas.edu.tr
Publications and helpful links
General Publications
- • 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.
- • 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.
- • 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.
- • Basheti, IA., Bosnic-Anticevich, SZ., Armour, CL., Reddel, HK. (2014). Checklists for powder ınhaler technique: A review and recommendations. Respir Care;59(7):1140-1154.
- • Carpenter, DM., Alexander, DS., Elio, A., DeWalt, D., Lee, C., Sleath, BL. (2016). Using tailored videos to teach ınhaler technique to children with asthma: Results from a school nurse-led pilot study. Journal of Pediatric Nursing; 31: 380-389
- • Goodman, K., Arriaga, RI., Korman, R., Zafar, F., Stephens, C. et al. (2024). Pediatric emergency department-based asthma education tools and parent/child asthma knowledge. Allergy, Asthma & Clinical Immunology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202512
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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