Effect of Inhalation Therapy on Children's Fear and Anxiety Levels and Physiological Parameters

NCT ID: NCT06486610

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-30

Brief Summary

The research was planned as a randomized controlled study. Between July 2023 and July 2025, he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer. It includes children aged 3-6 and their mothers receiving treatment. The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research. "Introductory Information Form", "Child Fear Scale", "Emotional Indicators Scale in Children", "Physiological Parameter Tracking Form" will be used to collect data. "Nebulizer with Toy Figure", "Sound Insulated (Silent) Nebulizer" and "Toy with Fish Figure" will be used as research materials.

Detailed Description

The research was planned as a randomized controlled study. Between July 2023 and July 2025, he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer. It includes children aged 3-6 and their mothers receiving treatment. The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research. "Introductory Information Form", "Child Fear Scale", "Emotional Indicators Scale in Children", "Physiological Parameter Tracking Form" will be used to collect data. "Nebulizer with Toy Figure", "Sound Insulated (Silent) Nebulizer" and " Toy with Fish Figure" will be used as research materials.

Data Collection:

Data for the study will be obtained through face-to-face interviews. Initially, children in the groups using either a toy-figured nebulizer or a Sound-Insulated (Silent) Nebulizer will complete an Introductory Information Form. The physiological parameters of the children will be measured by an experienced nurse in pediatric emergency care 15 minutes before, during the 10th minute of, and 15 minutes after the nebulizer medication application, and recorded on a 'Physiological Parameters Form.' Additionally, the Child Fear Scale and the Emotional Indicators in Children Scale will be administered 15 minutes before, during the 10th minute of, and 15 minutes after the medication application with the toy-figured nebulizer. For the control group, routine inhalation therapy of the service will be applied without any additional intervention. Children in this group will also fill out the Introductory Information Form. Their life signs will be measured similarly by the experienced nurse and recorded on a 'Physical Parameters Form.' The Child Fear Scale and Emotional Indicators in Children Scale will be administered during the 10th minute and 15 minutes after the routine medication application. Due to the nature of the study, blinding during the execution will not be possible; however, to prevent potential bias, measurements will be taken by both the experienced nurse (for physiological parameters, Child Fear Scale, Emotional Indicators in Children Scale) and parents (for Child Fear Scale, Emotional Indicators in Children Scale). Statistical analysis and reporting will be conducted without knowledge of which group is the experimental or control group (coding will be applied).

Data Evaluation:

Data processing and statistical analyses will be performed using Statistical Package for the Social Sciences for Windows 20.0. For measurements not conforming to a normal distribution, non-parametric methods will be utilized. The Kruskal-Wallis H test (χ2-table value) will be used for comparing three or more independent groups. Pearson-χ2 cross-tabulations will be employed to examine the relationships between two qualitative variables. The Spearman correlation coefficient will be used to analyze the relationships between two quantitative variables that do not follow a normal distribution.

Ethical Principles of the Research:

For the execution of the study, official permission has been obtained from the Ethical Committee of the Recep Tayyip Erdogan University Faculty of Medicine. Children eligible for the research group, along with their parents, will be informed about the purpose of the study, and their questions will be answered before obtaining their verbal and written consent. Parents and children will be assured that the data collected during the research will be processed anonymously and confidentially, will not be used outside of this study, and they may withdraw from the study at any time.

Conditions

Anxiety and Fear

Study Design

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

Study Groups

Control Group: Routine clinical practice

Fear, Emotional Indicators and Physiological Parameters in Children

Group Type: NO_INTERVENTION

No interventions assigned to this group

Therapeutic play: Fish-shaped nebulizer and fish-shaped toy

Fear, Emotional Indicators and Physiological Parameters in Children

Group Type: EXPERIMENTAL

Fish-shaped nebulizer and fish-shaped toy

Intervention Type: BEHAVIORAL

In order to reduce the child's fear and anxiety, it is planned to apply inhalation therapy using a nebulizer with a red fish figure and an amigurumi toy with a red fish figure.

silent nebulizer

Fear, Emotional Indicators and Physiological Parameters in Children

Group Type: EXPERIMENTAL

Silent nebulizer

Intervention Type: DEVICE

It is planned to apply inhalation therapy using a silent nebulizer to reduce the child's fear and anxiety.

Interventions

Fish-shaped nebulizer and fish-shaped toy

In order to reduce the child's fear and anxiety, it is planned to apply inhalation therapy using a nebulizer with a red fish figure and an amigurumi toy with a red fish figure.

Intervention Type: BEHAVIORAL

Silent nebulizer

It is planned to apply inhalation therapy using a silent nebulizer to reduce the child's fear and anxiety.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Having a child between the ages of 3-6
• Nebulizer and inhaler treatment will be applied
• The child does not have a mental or neurological disability
• Applying due to respiratory system disease
• The presence of the child's mother during the application period
• Mother and child can speak Turkish
• The mother does not have any obstacle to communication
• Mother's literacy
• Parent and child volunteering to participate in the research.

Exclusion Criteria

• The child and parent have previously experienced inhalation therapy with a nebulizer.
• The child is hyperthermic (body temperature is 38 C and above)
• The child has pain,
• The child is in the terminal period,
• The parent has a condition that prevents him/her from evaluating the scale (mental disability, etc.).

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Recep Tayyip Erdogan University

OTHER

Sponsor Role: lead

Responsible Party

Mehtap METİN KARAASLAN

Study Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehtap METİN KARAASLAN

Role: STUDY_DIRECTOR

Recep Tayyip Erdogan Universİty

Locations

Recep Tayyip Erdoğan University Faculty of Health Sciences

Rize, Güneysu, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1528/TSA-2023-1528

Identifier Type: -

Identifier Source: org_study_id