NCT05213013

The Effect of Toy-Type Nebulizer on Fear and Anxiety in Children Receiving Inhaler Treatment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Aylin Kurt · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to determine the effect of toy-type nebulizers on fear and anxiety in children receiving inhaler therapy. The research hypotheses are as follows: H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Child Fear Scale" and "Child Anxiety Scale-State" during and after the inhaler treatment with a toy-type nebulizer. H1: During and after the s inhaler treatment with the toy-type nebulizer, the mean score of the "Child Fear Scale" and "Child Anxiety Scale-State" is significantly higher in the intervention group compared to the control group.

Detailed description

In this study, there will be two groups as the intervention (who will receive inhaler treatment with an education and toy type nebulizer) and the control group (who will not receive training and will receive inhaler treatment with a classic-looking nebulizer). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 32 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. Inhaler treatment will be applied to both the intervention and control groups. Both the parent and the child in the intervention group will be trained on the use of a nebulizer/mask. The children in the intervention group will be treated with a toy-type nebulizer and the group will be treated with an inhaler, and the control group will be given inhaler treatment with the standard nebulizer in the hospital. Two researchers were employed for the inhaler treatment both for the intervention and control groups. One researcher performed the inhaler treatment for all children and the other researcher helped the children to assess their fear and anxiety level. Fear and anxiety in children were evaluated by the children and their parents who before, during, and the procedure, and five minutes after the procedure. The inhaler treatment procedure was performed by the same researcher both in the intervention and control groups.

Conditions

• Children, Only
• Fear Anxiety
• Hospitalism in Children

Interventions

Type	Name	Description
OTHER	inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/mask	The children (experimental group), will receive training and inhaler treatment with the toy-type nebulizer. The training topics is as follows: * For effective nebulization, it should be ensured that the parts of the mask are assembled completely and correctly. * The child should be in an upright sitting position during nebulization. * During the procedure, normal breathing should be given into the mask. * As the medicine is finished, a sizzling sound is heard from the device. * After the nebula is over, the face should be washed and the mouth should be rinsed to remove the drug residues accumulated on the face and mouth.

Timeline

• Start date: 2022-01-30
• Primary completion: 2023-01-28
• Completion: 2023-01-30
• First posted: 2022-01-28
• Last updated: 2023-02-08

Locations

1 site across 1 country: Turkey (Türkiye)