Effects of Interactive Toys and Robots on Anxiety and Fear in Children Receiving Nebulized Inhalation in the Pediatric Emergency Department

Not Applicable

Not yet recruiting

• Conditions: Child; Fear Anxiety; Inhalant Use

• Registration Number: NCT07056816
• Lead Sponsor: Aylin Kurt

Brief Summary

Pediatric emergency services are of critical importance for pediatric patients admitted due to sudden illnesses and traumas. However, these environments are serious sources of stress and anxiety for children due to reasons such as uncertainty, pain, and separation anxiety. The emergency service experience can have long-term effects on the child's psychological state and negatively affect the success of medical interventions. Therefore, the development and implementation of various methods to reduce children's anxiety has become a great necessity. In recent years, interactive toys and robotic systems have been increasingly used in medical settings to reduce children's anxiety. Such technological tools have been shown to provide emotional support to children, reduce stress levels by distracting them, and make medical procedures more tolerable. However, there is not enough evidence-based research on the effectiveness of interactive toys and robots, especially in emergency settings, during common but frightening procedures such as nebulized inhalation. This study aims to evaluate the effect of interactive toys and robots on anxiety and fear in children receiving nebulized inhalation treatment in pediatric emergency services. This study, which will be conducted using a randomized controlled design, will make a significant contribution to understanding and improving children's psychological responses to medical procedures. The study was planned as a randomized controlled trial. The population of this study will be conducted in the pediatric emergency department of Ankara Provincial Health Directorate Yıldırım Beyazıt University Yenimahalle Education and Research Hospital between 05.05.2025-05.05.2026. The sample of this study will consist of 72 children aged between 4-10 who agreed to participate in the study and met the inclusion criteria and who received nebulized inhalation treatment and met the inclusion criteria.

Hypotheses of the study:

H0 = Playing with interactive toys and interactive robots during nebulized inhalation treatment has no effect on anxiety and fear in children.

H1 = Playing with interactive toys and interactive robots during nebulized inhalation treatment is effective in reducing anxiety and fear in children.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-29
• Study First Submitted QC: 2025-06-29
• Last Update Submitted: 2025-06-29
• Study Start: 2025-06-30
• Primary Completion: 2025-07-01
• Study First Posted: 2025-07-09
• Last Update Posted: 2025-07-09
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Being a child between the ages of 4-10,
• Receiving nebulized inhalation treatment in the pediatric emergency department,
• The parent agreeing to participate in the research,
• The child not having speech or vision impairments or any other disabilities that would hinder or prevent communication.

Exclusion Criteria

• Children whose parents' permission cannot be obtained
• The child's speech and vision impairment, or any other disability that would make communication difficult or prevent it.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The level of anxiety is evaluated using the Children Anxiety Meter-State	during the procedure	The Children's Anxiety Meter (CAM-S) assesses children's anxiety in clinical settings and is used prior to medical procedures. The CAM is drawn like a thermometer with a bulb at the bottom and contains horizontal lines at intervals going upwards. Scale scores range from 0 to 10, where higher values represent higher anxiety. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children

Secondary Outcome Measures

Name	Time	Method
The level of anxiety is evaluated using the Child Fear Scale	during the procedure	Child Fear Scale assesses children's fear in clinical settings and is used prior to medical procedures. The Child Fear Scale (CFS) consists of facial expressions ranging from a neutral face on the far left (0 points: no fear/anxiety) to a frightened face on the far right (4 points: extreme fear/anxiety). Children are asked to mark their level of fear or anxiety by choosing the most appropriate facial expression to represent them. Personal reports and records from children, their parents, the researcher, and the nurse, who are asked to mark the scale with a pen, are used to assess the anxiety levels of children.