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

NCT06486610 | Completed

• 1 other identifier: 1528/TSA-2023-1528
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety and Fear

Keywords

child; nebulizer; fear; anxiety; therapeutic play

Outcome Measures

Primary Outcomes (2)

• Child Fear Scale

  This scale was developed to measure the anxiety levels in children. The facial muscle changes in expressions of fear have been illustrated by a graphic artist based on photographs of frightened faces. The scale can be used by families, children, or researchers to assess children. It presents a scale containing five facial expressions, scored between 0 and 4. A score of 0 indicates no fear or anxiety, while a score of 4 indicates the highest level of fear or anxiety. These are recognized as: "0" neutral expression (no anxiety), "1" very slight fear (very low anxiety), "2" mild fear (mild anxiety), "3" more fear (increased anxiety), "4" the most extreme fear (severe anxiety). This scale can be applied to measure fear and anxiety before and during medical procedures.

  one year

• Emotional Indicators Scale for Children

  This scale is an easily administered and evaluated tool used to objectively identify emotional responses of children to medical procedures. The emotional indicators on the scale are assessed based on five parameters: facial expression, voice, activity, interaction, and cooperation level. These five parameters are scored from 1 to 5, with the lowest possible score being 5 and the highest being 25. The scale has a Cronbach's alpha reliability coefficient of 0.88. In this study, the scale will be utilized to assess the emotional indicators of children during inhalation therapy.

  one year

Study Arms (3)

Control Group: Routine clinical practice

NO INTERVENTION

Fear, Emotional Indicators and Physiological Parameters in Children

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

EXPERIMENTAL

Fear, Emotional Indicators and Physiological Parameters in Children

Behavioral: Fish-shaped nebulizer and fish-shaped toy

silent nebulizer

EXPERIMENTAL

Fear, Emotional Indicators and Physiological Parameters in Children

Device: Silent nebulizer

Interventions

Fish-shaped nebulizer and fish-shaped toy 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.

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

Silent nebulizer DEVICE

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

silent nebulizer

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Health Sciences

Rize, Güneysu, 53100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Mehtap METİN KARAASLAN

  Recep Tayyip Erdogan Universİty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: July 3, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)