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NCT Number: NCT07452731

Effectiveness of a Mastery Learning Education Program for Parents of Children Using Inhaler Therapy in an Emergency Unit

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.

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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

İhsan Doğramacı Children's Hospital

Ankara, Turkey (Türkiye)

Location status: Recruiting

Location contact

Bulent Ecevit University, Zonguldak Tülay Kuzlu Ayyıldız, Phd

CONTACT

[email protected]

+90 (0372) 291 24 82

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Emine Şahin, Phd Student

CONTACT

[email protected]

+09 (0372) 291 24 82

Tülay Kuzlu Ayyıldız, Phd

CONTACT

[email protected]

+09 (0372) 291 24 82

Sponsors and collaborators

Lead sponsor

Emine ŞAHİN

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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