FearNCT06568120
Effect of Using a Dragon Design Nebulizer Mask on Treatment Duration, Compliance and Fear in Children
A study testing dragon themed nebulizer masks in people with Fear, run by Koç University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Fear
- What is being tested?
- dragon themed nebulizer masks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2024to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Fear
- Being tested
- dragon themed nebulizer masks
- Keywords
- children, emergency room, fear
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dragon themed nebulizer masksDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: dragon themed nebulizer masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eysan Hanzade Umac, Koç University
- Investigators
- Eyşan Hanzade Savaş, PhD, Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568120
- Sponsor's protocol ID
- kocuniversty
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Savas EH, Uysal G, Akdag MY, Sumengen AA, Semerci Sahin R. The effect of using a dragon-themed nebulizer mask on treatment application duration, adherence, and fear in children presenting to the emergency department: A randomized controlled trial. J Pediatr Nurs. 2026 Oct 23:S0882-5963(26)00526-9. doi: 10.1016/j.pedn.2026.10.018. Online ahead of print.
PubMed 42919686
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06568120
- Acronym / sponsor ID
- kocuniversty
- Conditions
- Fear
- Keywords
- children, emergency room, fear
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 23 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: dragon themed nebulizer masksChildren 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. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dragon themed nebulizer masksThis 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. | Device | Dragon Mask Group |
Primary outcome
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.
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 42919686Savas EH, Uysal G, Akdag MY, Sumengen AA, Semerci Sahin R. The effect of using a dragon-themed nebulizer mask on treatment application duration, adherence, and fear in children presenting to the emergency department: A randomized controlled trial. J Pediatr Nurs. 2026 Oct 23:S0882-5963(26)00526-9. doi: 10.1016/j.pedn.2026.10.018. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyşan Hanzade Savaş, PhD principal investigator
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dragon themed nebulizer masks in people with Fear, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eyşan Hanzade Savaş, PhD (5068418841, eumac14@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06568120, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.