Effect of Using a Dragon Design Nebulizer Mask on Treatment Duration, Compliance and Fear in Children

NCT06568120 | Not Yet Recruiting

• 1 other identifier: kocuniversty
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Incorporating playful elements into medical devices has been shown to enhance the overall experience for pediatric patients. Children want a healthcare setting that is spacious, creative, imaginative, and contemporary. Additionally, a current retrospective study of 127,368 pediatric patients indicates that 71.26% of the visits involved children under five years old, and 23.64% of the cases were due to respiratory infections. This information highlights the prevalence of inhaler therapy in emergency departments, particularly among young children with respiratory issues. This study aims to evaluate the impact of using dragon/turtle-themed nebulizer masks on treatment application time, treatment adherence, and fear levels in children who present to emergency rooms. By addressing these environmental and procedural challenges, the study seeks to improve the overall experience and outcomes for pediatric patients undergoing inhaler therapy.

Conditions

Fear

Keywords

children; emergency room; fear

Outcome Measures

Primary Outcomes (1)

• Fear - Child Fear Scale

  Thurillet et al. (2022) is used to learn about children's fears based on the autobiographical stories of children aged 4-12. The Turkish adaptation was made by Tavşan et al. in 2023. The scale consists of six facial expressions. The scale is graded with a score between 0 and 10 (graded gradually by two) along with fear and pain rating rates. It is seen that the first facial expression does not indicate fear, fear increases from right to left, and fear is most common in people's facial expressions.

  Immediately before (baseline) treatment (approximately 5 minutes before), each child's fear level will be assessed by the child and the nurse. Similarly, fear levels will be measured again during the intervention.

Secondary Outcomes (1)

• Duration of Treatment and Compliance

  During the intervention, children will be given nebulizer treatment appropriate to their age, and the duration of treatment and compliance will be recorded by the nurse. This takes an average of 15-20 minutes.

Study Arms (2)

Standard care

NO INTERVENTION

Children aged 3-6 who require nebulizer treatment in the emergency department, along with their families, will first be informed by one of the researchers. Then, children who are randomly assigned to the control group will be treated according to the institution's standard care procedures. The child and their family will be informed immediately before the treatment procedure. During the treatment, the child will be treated using a standard nebulizer mask appropriate for their age, in accordance with the institution's routine care procedures, and the parent will remain with the child throughout the treatment. The child's level of fear will be assessed by both the child and the nurse before and during the treatment. Additionally, the nurse will record the total duration of inhaler treatment and the child's adherence to the treatment.

Dragon Mask Group

EXPERIMENTAL

Children who present to the emergency department and require nebulizer treatment will be randomly assigned to either the experimental or control groups. First, one of the researchers will meet with the child and their parent to provide information about the study. If the child and family agree to participate and are assigned to the experimental group, the child will be asked which mask design they prefer to use during the inhaler treatment: a dragon or a turtle. Additionally, before the treatment, the fear level of each child will be assessed by both the child and the nurse. During the treatment process, the children will receive nebulizer treatment appropriate for their age, and the duration and adherence to the treatment will be recorded by the nurse. Similarly, fear levels will be measured immediately before and during the treatment.

Device: dragon themed nebulizer masks

Interventions

dragon themed nebulizer masks DEVICE

This study is an experimental investigation aiming to evaluate the effect of a dragon-themed nebulizer mask (Figure 1), identified during a literature review by the researchers, on the duration of inhaler treatment application, treatment adherence, and children's fear levels. The dragon-designed nebulizer mask, with its colorful and toy-like appearance, is intended to calm children using pediatric aerosol masks. The mask is made of very soft, latex-free plastic, ensuring comfortable use for pediatric patients. It is compatible with all nebulizers and suitable for use in hospital settings. Unlike standard nebulizer masks, its appearance is designed with a dragon character specifically for pediatric patients. The mask is manufactured in China.

Dragon Mask Group

Eligibility Criteria

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

You may qualify if:

• Aged between 3-6 years,
• Presenting to the emergency department with a respiratory problem (such as an upper respiratory tract infection) requiring nebulizer treatment,
• In general good health and suitable for nebulizer treatment (i.e., not having conditions like severe allergies or chronic respiratory failure),
• Possessing age-appropriate language and communication skills,
• Not previously familiar with the dragon-themed masks,
• Having parental consent.

You may not qualify if:

• Children with major medical or psychiatric comorbidities as reported by the physician, nurse, or parent,
• Children with a chronic health condition requiring regular nebulizer use (such as asthma),
• Children with a fever of 38°C (100.4°F) or higher,
• Children who have started treatment with sedative or anticonvulsant medications,
• Children and parents with visual, auditory, verbal, or cognitive impairments that would interfere with the use of the intervention equipment.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eyşan Hanzade Savaş, PhD

  Koç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eyşan Hanzade Savaş, PhD

CONTACT

5068418841; eumac14@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching and Research Assistant

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 23, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)