Clinical trial NCT06568120: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fear
Keywords: children
emergency room
fear
Lead sponsor: Koç University
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: SUPPORTIVE_CARE

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.

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.

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.

Primary outcomes:
measure: Fear - Child Fear Scale
timeFrame: 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:
measure: Duration of Treatment and Compliance
timeFrame: 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.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koc University
Study officials:
affiliation: Koç University
name: Eyşan Hanzade Savaş, PhD
role: PRINCIPAL_INVESTIGATOR
References: