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

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.

Study Overview

• Status: Recruiting
• Conditions: Children, Only; Fear Anxiety; Hospitalism in Children
• Intervention / Treatment: Other: inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/mask

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Bartın, Turkey, 74100
    • Recruiting
    • Bartın University
    • Contact: Aylin Kurt; Phone Number: +905382087211; Email: aylinkurt67@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; All registered participants in the control group, will receive inhaler treatment with the toy-type nebulizer in the hospital. Both the parent and the child in the intervention group will be trained on the use of a nebulizer/mask.	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.
NO_INTERVENTION: No intervention; No intervention. All registered participants in the control group, will receive inhaler treatment with the standard nebulizer in the hospital. Both the parent and the child in the intervention group will not be trained on the use of a nebulizer/mask.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between the mean score of the "Child Fear Scale" between intervention and control groups	"The Child Fear Scale" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will fear about the inhaler treatment with a nebulizer in children. This scale will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's fear level before, during and after the proposed intervention. The scale will be made without training and inhaler treatment with a standard nebulizer in the control group. At the end of the study, difference between the mean score of "The Child Fear Scale" between intervention and control groups will be examined. The Child Fear Scale total score mean of the children in the intervention group will be higher after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.	12 months
Difference between the mean score of "The Child Anxiety Meter-State" between intervention and control groups	"The Child Anxiety Meter-State" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will anxiety about the inhaler treatment with a nebulizer in children. This scale will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety level before, during and after the proposed intervention. The scale will be made without training and inhaler treatment with a standard nebulizer in the control group. At the end of the study, difference between the mean score of "The Child Anxiety Meter-State" between intervention and control groups will be examined. The Child Anxiety Meter-State total score mean of the children in the intervention group will be higher after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.	"The Child Fear Scale" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will address fear about the inhaler treatment with a nebulizer in children. These surveys will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's fear before, during and after the proposed intervention. The Child Fear Scale total score mean of the children in the intervention group will be higher after the intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.	12 months
Change of the mean scores obtained by the children in the intervention group from the "Child Anxiety Meter-State" before and after the intervention.	"The Child Anxiety Meter-State" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will address anxiety about the inhaler treatment with a nebulizer in children. These surveys will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety before, during and after the proposed intervention. The Child Anxiety Meter-State total score mean of the children in the intervention group will be higher after the intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.	12 months

Collaborators and Investigators

• Sponsor: Aylin Kurt

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2022
• Primary Completion (ANTICIPATED): January 28, 2023
• Study Completion (ANTICIPATED): January 30, 2023

Study Registration Dates

• First Submitted: December 4, 2021
• First Submitted That Met QC Criteria: January 15, 2022
• First Posted (ACTUAL): January 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2021-SBB-0333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 12 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No