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

NCT05213013 | Unknown

• 1 other identifier: 2021-SBB-0333
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Children, Only; Fear Anxiety; Hospitalism in Children

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.

  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.

  12 months

Study Arms (2)

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

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.

Interventions

inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/mask OTHER

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.

Experimental

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aylin Kurt: lead

Study Sites (1)

Bartın University

Bartın, 74100, Turkey (Türkiye)

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Children and their parents
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Children and their parents

Study Record Dates

• First Submitted: December 4, 2021
• First Posted: January 28, 2022
• Study Start: January 30, 2022
• Primary Completion: January 28, 2023
• Study Completion: January 30, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months

Locations

TU (1)