The Effects Of Toy In Chıldren Durıng Inhaler Therapy

NCT06924528 | Completed

• 1 other identifier: BakırköySadiKonuk-aboke-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Respiratory Tract Disease; Respiratory Disease

Keywords

children; inhalation therapy; toy; anxiety; emotional state

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Children's Emotional Manifestation Scale

  five months

Study Arms (2)

The control group

NO INTERVENTION

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.

The intervention group

EXPERIMENTAL

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

Interventions

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.

Also known as: using toy

The intervention group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Bakirkoy Dr Sadi Konuk Researching and Training Hospital

Istanbul, Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Respiration Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Seventy-two participants included in the study were divided into two groups: intervention and control. The assignment of participants to the intervention and control groups was done randomly by someone not involved in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The intervention group received the mask application on the toy. The control group did not receive the mask application on the toy.

Study Record Dates

• First Submitted: April 5, 2025
• First Posted: April 11, 2025
• Study Start: November 2, 2024
• Primary Completion: March 26, 2025
• Study Completion: April 5, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)