Clinical trial NCT05213013: The Effect of Toy-Type Nebulizer on Fear and Anxiety in Children Receiving Inhaler Treatment
Official title: The Effect of Toy-Type Nebulizer on Fear and Anxiety in Children Receiving Inhaler Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Children, Only
Fear Anxiety
Hospitalism in Children
Lead sponsor: Bartın Unıversity
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 64
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children and their parents
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* The child is between the ages of 4-10
* The child's application to the Pediatric Emergency Unit
* Child receiving inhaler treatment for the first time
* Parent and child agreeing to participate in the project
* Absence of speech and visual impairment of the child and his parents

Exclusion Criteria:

* The child is not between the ages of 4-10
* The child's application to another department except for the Pediatric Emergency Unit
* Child not receiving inhaler treatment for the first time
* Parent and child not agreeing to participate in the project
* Having speech and visual impairment of the child and his parents

Primary outcomes:
measure: Difference between the mean score of the "Child Fear Scale" between intervention and control groups
timeFrame: 12 months
measure: Difference between the mean score of "The Child Anxiety Meter-State" between intervention and control groups
timeFrame: 12 months
Secondary outcomes:
measure: Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.
timeFrame: 12 months
measure: Change of the mean scores obtained by the children in the intervention group from the "Child Anxiety Meter-State" before and after the intervention.
timeFrame: 12 months
Other outcomes:
Locations:
city: Bartın
country: Turkey
facility: Bartın University
Study officials:
References: