Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2025-12-26 @ 3:27 AM
Study NCT ID:
NCT06568120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Using a Dragon Design Nebulizer Mask on Treatment Duration, Compliance and Fear in Children
Sponsor:
Koç University
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: