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Completed
NCT07827781
The Effect of Using the Popit Toy and Stress Ball During Inhaler Therapy in Children
Conditions: Non-Pharmacological Interventions, NEBULIZATION
Sex: All
Ages: 4 Years – 6 Years
Healthy volunteers: No
Phase: NA
Enrollment: 105
Sponsor: Izmir Katip Celebi University
Location: Tarsus State Hospital Mersin
Summary
The goal of this clinical trial is to evaluate whether using a popit toy and a stress ball as distraction methods during inhaled medication administration can reduce anxiety, fear, and negative emotional responses and improve satisfaction in children aged 4-6 years receiving treatment in a pediatric emergency unit.
The main questions it aims to answer are:
* Does using a popit toy or a stress ball during inhaled medication administration reduce children's anxiety, fear, and negative emotional responses?
* Does using a popit toy or a stress ball improve children's satisfaction with the procedure?
* Do these distraction methods affect physiological parameters? To determine the effects of these non-pharmacological methods, researchers will compare the Popit toy group, the stress ball group, and the standard control group, which receives no intervention.
Researchers compared a pop-it toy group, a stress ball group, and a control group to determine the effects of these non-pharmacological methods.
Participants:
* Participants were randomly assigned to one of three groups: the pop-it toy group, the stress ball group, or the control group.
* They received inhalation therapy according to the standard treatment protocol.
* Assessments of anxiety, fear, emotional state, and satisfaction were conducted before and/or after the procedure.
* Physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) were measured before and after the administration of the inhalation medication.
Eligibility Criteria
Inclusion Criteria:
* Children aged 4 to 6 years.
* Presentation to the pediatric emergency unit with a respiratory disease requiring inhaled medication (nebulizer or inhaler therapy).
* Oxygen saturation (SpO₂) of 90% or higher before the procedure.
* No congenital anomalies.
* Not crying before the inhaled medication procedure.
* Parent or legal guardian able to provide written informed consent.
* Child willing to participate in the study.
Exclusion Criteria:
* The child being younger than 4 or older than 6 years of age
* Having communication, cognitive, or neurological issues
Source: ClinicalTrials.gov (NCT07827781). StuddyBuddy aggregates publicly available trial information.