Shortness of BreathNCT07452731
Effectiveness of a Mastery Learning Education Program for Parents of Children Using Inhaler Therapy in an Emergency Unit
A study testing Parent Education Program and Routine Care in people with Shortness of Breath, run by Emine ŞAHİN at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Shortness of Breath
- What is being tested?
- Parent Education Program and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2025to 6 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- - 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
Who cannot join
- Refusal to participate in the study.
- Incomplete data provision.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İhsan Doğramacı Children's Hospital
Ankara
Bulent Ecevit University, Zonguldak Tülay Kuzlu Ayyıldız, Phd, +90 (0372) 291 24 82, tkayyildiz@beun.edu.tr
About this study
Official 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
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.
Read the 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.
- Conditions
- Shortness of Breath
- Being tested
- Parent Education Program, Routine Care
- Keywords
- inhaler therapy, parent education, pediatric emergency
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Education ProgramBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parent Education Program |
| 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. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start5 Nov 2025
- Primary completion5 Nov 2026 (estimated)
- Study completion6 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Shortness of BreathStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emine ŞAHİN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emine ŞAHİN, Zonguldak Bulent Ecevit University
- Investigators
- Emine Şahin, Phd Student, Principal investigator, e.sahin@sabe.karaelmas.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452731
- Sponsor's protocol ID
- 202512
- Status last verified
- Mar 2026
- First submitted
- 11 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 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.
PubMed 24129338Carpenter 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.
PubMed 26947730Goodman 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.
PubMed 38528606
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07452731
- Acronym / sponsor ID
- 202512
- Conditions
- Shortness of Breath
- Keywords
- inhaler therapy, parent education, pediatric emergency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Emine ŞAHİNUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 6 Jun 2027 (estimated)
- First posted
- 5 Mar 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Other | Behavioral: Parent Education ProgramMothers 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 | Other: Routine CareParents 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. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- - 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.
Key exclusion criteria (2 listed)
- Refusal to participate in the study.
- Incomplete data provision.
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 |
|---|---|---|
| Parent Education ProgramMothers 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. | Behavioural | Intervention Group |
| Routine CareParents 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. | Other | Control Group - Routine Care |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- 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.
- Results publication: PubMed 24129338Basheti 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.
- Results publication: PubMed 26947730Carpenter 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.
- Results publication: PubMed 38528606Goodman 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.
- • Shah, RF., Gupta, RM. (2017). Video instruction is more effective than written instruction in improving inhaler techniqueLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Emine Şahin, Phd Student principal investigator
e.sahin@sabe.karaelmas.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Education Program and Routine Care in people with Shortness of Breath, run by Emine ŞAHİN 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 5 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Şahin, Phd Student (+09 (0372) 291 24 82, e.sahin@sabe.karaelmas.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and Reliability Study of the Inhaler Therapy Application Checklist (time frame: 12 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452731, which also lists 6 linked publications.
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 5 Mar 2026; AzTrials last refreshed its copy on 3 Nov 2026.