The Effects Of Toy In Chıldren Durıng Inhaler Therapy

NCT ID: NCT06924528

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-02
• Study Completion Date: 2025-04-05

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.

Conditions

Lower Respiratory Tract Disease; Respiratory Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

using toy during inhaler treatment

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

using toy

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ayse Boke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bakirkoy Dr Sadi Konuk Researching and Training Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BakırköySadiKonuk-aboke-01

Identifier Type: -

Identifier Source: org_study_id