INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.

Bronchospasm Clinical Trial

Official title:

INHALATION CHAMBER MANAGEMENT IN PEDIATRICS: EFFICACY OF AN EDUCATIONAL INTERVENTION IN PATIENTS DIAGNOSED WITH BRONCHOSPASM AND THEIR FAMILY CAREGIVERS.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555134
• Other study ID #: PuertadeHierro.
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2021
• Est. completion date: October 2024

Study information

• Verified date: September 2022
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Several studies show that unnecessary and frequent visits to the emergency department for bronchospasm care are associated with inadequate management of inhalers and poor education on the approach to respiratory distress. Main objective: To determine the degree of frequentation to the pediatric emergency department for bronchospasm at 1, 3 and 6 months after the educational intervention. Design: Randomized controlled clinical trial with two groups: EXPERIMENTAL will receive the educational intervention, along with usual care, and CONTROL will receive usual care. Subjects: pediatric patients (2-15 years) diagnosed with bronchospasm; in home treatment with inhalation chambers; and their parents. Emergency Department recruitment. Follow-up at home

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 121
• Est. completion date: October 2024
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

Inclusion Criteria:

• Patients between 2-15 years of age attending the Pediatric Emergency Department of the Hospital Universitario Puerta de Hierro Majadahonda (HUPHM) with a mild, moderate or severe bronchospasm crisis and who have used the inhalation chambers on at least one occasion; with autonomy in the use of the inhalation chambers at home

Exclusion Criteria:

• Not understanding Spanish

Related Conditions & MeSH terms

• Bronchial Spasm
• Bronchospasm

Intervention

Behavioral:
• educational intervention
will also have an extra educational intervention, a group intervention (4-6 people) through a one-hour training session via zoom, which will be given by the PI (extensive experience in the subject) a week after discharge from the ER. Information will be reinforced and doubts will be solved

Locations

Country	Name	City	State
Spain	Belén de la Rosa	Majadahonda	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of frequentation to the emergency department		6 months