Tarsus State Hospital
Mersin, Turkey (Türkiye)
NCT Number: NCT07827781
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.
Looking for future studies?
Notify Me4 year–6 year
All sexes
Interventional
Not applicable
Mersin, Turkey (Türkiye)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children use a Popit toy as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.
Other names: Popit toy
Children use a stress ball as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.
Other names: Stress ball
Time frame: 1 day
State anxiety measured using the Children's Anxiety Scale-State (CAS-S). Higher scores indicate higher anxiety levels.
Time frame: 1 day
Fear assessed using the Children's Fear Scale (CFS). Higher scores indicate greater fear.
Time frame: 1 day
Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS). Higher scores indicate more negative emotional responses
Time frame: 1 day
Children's satisfaction with the inhaled medication procedure measured using the Children's Satisfaction Scale. Higher scores indicate greater satisfaction.
Time frame: 1 day
Heart rate measured using a pulse oximeter.
Time frame: 1 day
Respiratory rate measured before and after the procedure.
Time frame: 1 day
Peripheral oxygen saturation measured using a pulse oximeter.
Time frame: 1 day
Body temperature measured before and after the procedure.
Izmir Katip Celebi University
Other
The Effect of the Popit Toy and Stress Ball on Anxiety, Fear, Emotional State, and Satisfaction Levels During Inhaler Medication Administration in Children
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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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