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

NCT ID: NCT05213013

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2023-01-30

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.

Conditions

Children, Only; Fear Anxiety; Hospitalism in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aylin Kurt

OTHER

Sponsor Role: lead

Responsible Party

Aylin Kurt

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bartın University

Bartın, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Facility Contacts

Aylin Kurt

Role: primary

aylinkurt67@gmail.com

+905382087211

Other Identifiers

2021-SBB-0333

Identifier Type: -

Identifier Source: org_study_id