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

NCT ID: NCT05555134

Last Updated: 2025-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Bronchospasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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CONTROL

receive usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

EXPERIMENTAL

receive the educational intervention, along with usual care

Group Type EXPERIMENTAL

educational intervention

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Puerta de Hierro University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Belén de la Rosa

Belén de la Rosa Roch

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Belén de la Rosa

Majadahonda, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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PuertadeHierro.

Identifier Type: -

Identifier Source: org_study_id

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