Clinical trial NCT06924528: The Effects Of Toy In Chıldren Durıng Inhaler Therapy
Official title: The Effects Of Toy In Chıldren Durıng Inhaler Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Respiratory Tract Disease
Respiratory Disease
Keywords: children
inhalation therapy
toy
anxiety
emotional state
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2025-04-11
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention group received the mask application on the toy. The control group did not receive the mask application on the toy.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to investigate the effect of using a toy that children like during inhaler treatment on children's anxiety and emotional state. In the study, an inhaler treatment will be applied to children with a mask placed on a toy that they like. The purpose of this intervention is to reduce the child's anxiety and increase their emotional adjustment by improving adherence to the treatment.

Detailed description: Respiratory diseases are commonly seen during childhood. Today, inhaler medication is frequently used in the treatment of lower respiratory tract diseases. Inhalation therapy is the process of delivering liquid medication in aerosol form directly to the respiratory tract and lungs using devices called nebulizers. Compared to other treatment methods, the direct delivery of medication to the lungs, the rapid onset of effect, and fewer systemic side effects make inhalation therapy the preferred method for treating children. In treatments administered through inhalation, if the inhalation is being applied for the first time, the child may experience fear and anxiety due to not knowing the procedure. After the nurse explains how the procedure is done, they should use distraction techniques to relax the child and support the effective continuation of the inhalation treatment. Distraction techniques are simple and inexpensive methods, and studies have proven their positive effect on children. This study is designed to investigate the effect of using a toy during inhaler treatment on children's anxiety and emotional state.

Eligibility criteria: Inclusion Criteria:

* The child being between the ages of 4 and 6,
* The child being scheduled to receive their first inhaler treatment after admission to the unit,
* No IV or IM interventions being performed before the inhaler treatment,
* The child and parents being willing to participate in the study,
* No mental or neurological disabilities present in the child or parent,
* The child not having any life-threatening illnesses,
* The child having an oxygen saturation of 95% or higher,
* The child's body temperature not exceeding 37.5 degrees Celsius,
* The child's cognitive level and motor development being appropriate for their age,
* The child being able to count up to 10,
* The parent being literate,
* No visual or auditory problems present in the child or parent

Exclusion Criteria:

* The child's general condition (tachycardia, fever, vomiting, etc.) and orientation (disorientation, lethargy, etc.) significantly deteriorating after the inhaler treatment begins,
* The parent or child wanting to withdraw from the study at any stage of the research.

Primary outcomes:
measure: children's anxiety meter state
timeFrame: five months
Secondary outcomes:
measure: Children's Emotional Manifestation Scale
timeFrame: five months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakirkoy Dr Sadi Konuk Researching and Training Hospital
Study officials:
References: