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.

Study Overview

• Status: Completed
• Conditions: Respiratory Disease; Lower Respiratory Tract Disease
• Intervention / Treatment: Other: using toy during inhaler 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34000
    • Bakirkoy Dr Sadi Konuk Researching and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: The control group; 5 minutes before starting the inhaler treatment, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. After washing hands, the aerosol medication ordered by the physician should be applied using a nebulizer mask. In the 5th minute after the inhaler treatment begins, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. 5 minutes after the inhaler treatment ends, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers.
Experimental: The intervention group; 5 minutes before starting the inhaler treatment, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. After washing hands, the aerosol medication ordered by the physician should be applied using a nebulizer mask. The child is introduced to the plush toy of Kral Şakir, a character they recognize from cartoons. After explaining that King Şakir also needs help to recover, the nebulizer mask is applied to the toy, and saline solution is added to the mask's reservoir. Then, the treatment is started together with the child. In the 5th minute after the inhaler treatment begins, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. 5 minutes after the inhaler treatment ends, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers.	Other: using toy during inhaler treatment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
children's anxiety meter state	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.	five months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Children's Emotional Manifestation Scale	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.	five months

Collaborators and Investigators

• Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2024
• Primary Completion (Actual): March 26, 2025
• Study Completion (Actual): April 5, 2025

Study Registration Dates

• First Submitted: April 5, 2025
• First Submitted That Met QC Criteria: April 5, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: children; anxiety; inhalation therapy; emotional state; toy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: BakırköySadiKonuk-aboke-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No