Effect of Using a Dragon Design Nebulizer Mask on Treatment Duration, Compliance and Fear in Children
ConditionFear
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorKoç University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
dragon themed nebulizer masks
DeviceThis 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Standard careNo intervention 0 interventions
Group B: Dragon Mask GroupExperimental treatment 1 intervention
Trial outcomes
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.
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 outcomes
1
Duration of Treatment and Compliance
The start and end times of the inhaler treatment of the children in the experimental and control groups, as well as whether the children have complied with the treatment, will be evaluated with a form. The children in the experimental and control groups will be observed by nurses throughout the treatment period. The treatment durations of the children and their behaviors towards the treatment will be recorded as follows.
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.Sponsors and contacts
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Source ClinicalTrials.gov
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