The Effects Of Toy In Chıldren Durıng Inhaler Therapy

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.

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Key information

Conditions

Lower Respiratory Tract Disease Anxiety Disorders Mental Disorders Respiration Disorders Respiratory Disease Respiratory Tract Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bakirkoy Dr Sadi Konuk Researching and Training Hospital

Istanbul, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

using toy during inhaler treatment

Other

The mask application on the toy will be performed only during the first inhaler treatment that the children receive in the emergency department.

Other names: using toy

Primary outcomes

children's anxiety meter state

Time frame: five months

To measure state anxiety, children are asked to mark how they feel "right now." To measure trait anxiety, another copy of the scale is presented, and they are asked to mark how they "usually feel at home." Examples of being at home are provided to the children, like "think about when you were playing outside with a friend" and "think about sitting quietly watching TV." Before completing the scale, children were screened for their ability to rank order by size. They were asked to count to 10, and then answer, "Which is bigger, 7 or 4?" Children were also asked to identify the smallest of a series of four stacking cups. Children unable to complete these tasks successfully or who did not understand the instructions did not complete the scale.

Secondary outcomes

Children's Emotional Manifestation Scale

Time frame: five months

In the scale, emotional indicators are evaluated based on five parameters. These parameters are: facial expression, voice, activity, interaction, and cooperation level. Each of these five parameters is scored on a scale from 1 to 5, with the lowest possible score being "5" and the highest possible score being "25."

In the first category, facial expression, the child's facial expressions observed by the researcher are scored on 5 items.

Secondly, in the vocalization category, the child's tearfulness is evaluated through 5 sub-items.

Thirdly, in the movement category, scoring is done based on the child's body language, using 5 sub-items.

Fourthly, in the interaction category, the child's verbal and non-verbal communication is evaluated through 5 sub-items.

Finally, in the cooperation category, the child's active or passive participation is observed and scored based on 5 sub-items.

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Apr 11, 2025
Registry last updated: Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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Completed