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

Official title

Effect of Using a Dragon Design Nebulizer Mask on Treatment Duration, Compliance and Fear in Children Presenting to the Emergency Department: A Randomized Controlled Trial

Overview

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.

Detailed description

The meaning of a disease or medical procedure may vary depending on the child's developmental milestones. Children aged 3-6 years, who are in the preoperational stage of cognitive development as defined by Piaget, often perceive hospital environments with curiosity and fear. This age group is characterized by a vivid imagination and limited understanding of the cause-and-effect relationship, which can lead to misconceptions about medical procedures and devices. For example, they may believe that they are being punished or that procedures or medical devices are more painful than they are. They may react with heightened anxiety, clinginess, or aggression. Even using face masks for aerosol therapy may cause distress in young children, as the masks can be perceived as scary or uncomfortable. Young children prefer a hospital environment that is bright, cheerful, warm, colorful, and comfortable. These environmental factors help reduce anxiety and create a more welcoming and less intimidating atmosphere for young patients.

Emergency rooms are often not designed to accommodate agitated young patients, featuring physical layouts that are not conducive to their care, noisy and chaotic environments, and limited access to therapeutic spaces. The care team may also lack the resources to manage agitated children effectively. On the other hand, recent studies have highlighted the importance of creating child-friendly medical environments to reduce anxiety and improve cooperation during treatment. 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.

Interventions

• Device dragon themed nebulizer masks
  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 pedi

Primary outcome measures

• Fear - Child Fear Scale [Time frame: 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 outcome measures (1)

• Duration of Treatment and Compliance [Time frame: 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.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Turkey (Türkiye) · 1 center

• Koc University — Istanbul

Identifiers

NCT: NCT06568120 · kocuniversty

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗