Anxiety and FearNCT06486610
Effect of Inhalation Therapy on Children's Fear and Anxiety Levels and Physiological Parameters
A study testing Fish-shaped nebulizer and fish-shaped toy and Silent nebulizer in people with Anxiety and Fear, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
The research was planned as a randomized controlled study. Between July 2023 and July 2025, he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer. It includes children aged 3-6 and their mothers receiving treatment. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Anxiety and Fear
- What is being tested?
- Fish-shaped nebulizer and fish-shaped toy and Silent nebulizer
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 30 May 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
- Having a child between the ages of 3-6
- Nebulizer and inhaler treatment will be applied
- The child does not have a mental or neurological disability
- Applying due to respiratory system disease
- The presence of the child's mother during the application period
- Mother and child can speak Turkish
Show all 9Show fewer
- The mother does not have any obstacle to communication
- Mother's literacy
- Parent and child volunteering to participate in the research.
Who cannot join
- The child and parent have previously experienced inhalation therapy with a nebulizer.
- The child is hyperthermic (body temperature is 38 C and above)
- The child has pain,
- The child is in the terminal period,
- The parent has a condition that prevents him/her from evaluating the scale (mental disability, etc.).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdoğan University Faculty of Health Sciences
Rize, Güneysu, 53100
About this study
Official title: Inhalation With Toy Figure and Sound Insulated Nebulizer Effect of Treatment on Children's Fear and Anxiety Levels and Physiological Parameters: Randomized Controlled Study
The research was planned as a randomized controlled study. Between July 2023 and July 2025, he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer. It includes children aged 3-6 and their mothers receiving treatment. The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research. "Introductory Information Form", "Child Fear Scale", "Emotional Indicators Scale in Children", "Physiological Parameter Tracking Form" will be used to collect data. "Nebulizer with Toy Figure", "Sound Insulated (Silent) Nebulizer" and "Toy with Fish Figure" will be used as research materials.
Read the detailed description
The research was planned as a randomized controlled study. Between July 2023 and July 2025, he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer. It includes children aged 3-6 and their mothers receiving treatment. The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research. "Introductory Information Form", "Child Fear Scale", "Emotional Indicators Scale in Children", "Physiological Parameter Tracking Form" will be used to collect data. "Nebulizer with Toy Figure", "Sound Insulated (Silent) Nebulizer" and " Toy with Fish Figure" will be used as research materials.
Data Collection:
Data for the study will be obtained through face-to-face interviews. Initially, children in the groups using either a toy-figured nebulizer or a Sound-Insulated (Silent) Nebulizer will complete an Introductory Information Form. The physiological parameters of the children will be measured by an experienced nurse in pediatric emergency care 15 minutes before, during the 10th minute of, and 15 minutes after the nebulizer medication application, and recorded on a 'Physiological Parameters Form.' Additionally, the Child Fear Scale and the Emotional Indicators in Children Scale will be administered 15 minutes before, during the 10th minute of, and 15 minutes after the medication application with the toy-figured nebulizer. For the control group, routine inhalation therapy of the service will be applied without any additional intervention. Children in this group will also fill out the Introductory Information Form. Their life signs will be measured similarly by the experienced nurse and recorded on a 'Physical Parameters Form.' The Child Fear Scale and Emotional Indicators in Children Scale will be administered during the 10th minute and 15 minutes after the routine medication application. Due to the nature of the study, blinding during the execution will not be possible; however, to prevent potential bias, measurements will be taken by both the experienced nurse (for physiological parameters, Child Fear Scale, Emotional Indicators in Children Scale) and parents (for Child Fear Scale, Emotional Indicators in Children Scale). Statistical analysis and reporting will be conducted without knowledge of which group is the experimental or control group (coding will be applied).
Data Evaluation:
Data processing and statistical analyses will be performed using Statistical Package for the Social Sciences for Windows 20.0. For measurements not conforming to a normal distribution, non-parametric methods will be utilized. The Kruskal-Wallis H test (χ2-table value) will be used for comparing three or more independent groups. Pearson-χ2 cross-tabulations will be employed to examine the relationships between two qualitative variables. The Spearman correlation coefficient will be used to analyze the relationships between two quantitative variables that do not follow a normal distribution.
Ethical Principles of the Research:
For the execution of the study, official permission has been obtained from the Ethical Committee of the Recep Tayyip Erdogan University Faculty of Medicine. Children eligible for the research group, along with their parents, will be informed about the purpose of the study, and their questions will be answered before obtaining their verbal and written consent. Parents and children will be assured that the data collected during the research will be processed anonymously and confidentially, will not be used outside of this study, and they may withdraw from the study at any time.
- Conditions
- Anxiety and Fear
- Being tested
- Fish-shaped nebulizer and fish-shaped toy, Silent nebulizer
- Keywords
- child, nebulizer, fear, anxiety, therapeutic play
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish-shaped nebulizer and fish-shaped toyBehavioural
In order to reduce the child's fear and anxiety, it is planned to apply inhalation therapy using a nebulizer with a red fish figure and an amigurumi toy with a red fish figure.
Silent nebulizerDevice
It is planned to apply inhalation therapy using a silent nebulizer to reduce the child's fear and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Routine clinical practice | No intervention | Fear, Emotional Indicators and Physiological Parameters in Children |
| Therapeutic play: Fish-shaped nebulizer and fish-shaped toy | Experimental | Fear, Emotional Indicators and Physiological Parameters in Children Receives: Behavioral: Fish-shaped nebulizer and fish-shaped toy |
| silent nebulizer | Experimental | Fear, Emotional Indicators and Physiological Parameters in Children Receives: Device: Silent nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale
This scale was developed to measure the anxiety levels in children. The facial muscle changes in expressions of fear have been illustrated by a graphic artist based on photographs of frightened faces. The scale can be used by families, children, or researchers to assess children. It presents a scale containing five facial expressions, scored between 0 and 4. A score of 0 indicates no fear or anxiety, while a score of 4 indicates the highest level of fear or anxiety. These are recognized as: "0" neutral expression (no anxiety), "1" very slight fear (very low anxiety), "2" mild fear (mild anxiety), "3" more fear (increased anxiety), "4" the most extreme fear (severe anxiety). This scale can be applied to measure fear and anxiety before and during medical procedures.
Measured: one year
Emotional Indicators Scale for Children
This scale is an easily administered and evaluated tool used to objectively identify emotional responses of children to medical procedures. The emotional indicators on the scale are assessed based on five parameters: facial expression, voice, activity, interaction, and cooperation level. These five parameters are scored from 1 to 5, with the lowest possible score being 5 and the highest being 25. The scale has a Cronbach's alpha reliability coefficient of 0.88. In this study, the scale will be utilized to assess the emotional indicators of children during inhalation therapy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 May 2024
- Primary completion30 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehtap METİN KARAASLAN, Recep Tayyip Erdogan University
- Investigators
- Mehtap METİN KARAASLAN, Study director, Recep Tayyip Erdogan Universİty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486610
- Sponsor's protocol ID
- 1528/TSA-2023-1528
- Status last verified
- Jul 2025
- First submitted
- 3 May 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhalation With Toy Figure and Sound Insulated Nebulizer Effect of Treatment on Children's Fear and Anxiety Levels and Physiological Parameters: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06486610
- Acronym / sponsor ID
- 1528/TSA-2023-1528
- Conditions
- Anxiety and Fear
- Keywords
- child, nebulizer, fear, anxiety, therapeutic play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 3 Jul 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.
The research was planned as a randomized controlled study. Between July 2023 and July 2025, he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer. It includes children aged 3-6 and their mothers receiving treatment. The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research. "Introductory Information Form", "Child Fear Scale", "Emotional Indicators Scale in Children", "Physiological Parameter Tracking Form" will be used to collect data. "Nebulizer with Toy Figure", "Sound Insulated (Silent) Nebulizer" and "Toy with Fish Figure" will be used as research materials.
Detailed description
The research was planned as a randomized controlled study. Between July 2023 and July 2025, he was hospitalized in the pediatric emergency department of Recep Tayyip Erdogan University Training and Research Hospital and was treated with a nebulizer. It includes children aged 3-6 and their mothers receiving treatment. The sample of the research will consist of 120 children and their mothers who applied to the pediatric emergency department between the specified dates and met the inclusion criteria and volunteered to participate in the research. "Introductory Information Form", "Child Fear Scale", "Emotional Indicators Scale in Children", "Physiological Parameter Tracking Form" will be used to collect data. "Nebulizer with Toy Figure", "Sound Insulated (Silent) Nebulizer" and " Toy with Fish Figure" will be used as research materials.
Data Collection:
Data for the study will be obtained through face-to-face interviews. Initially, children in the groups using either a toy-figured nebulizer or a Sound-Insulated (Silent) Nebulizer will complete an Introductory Information Form. The physiological parameters of the children will be measured by an experienced nurse in pediatric emergency care 15 minutes before, during the 10th minute of, and 15 minutes after the nebulizer medication application, and recorded on a 'Physiological Parameters Form.' Additionally, the Child Fear Scale and the Emotional Indicators in Children Scale will be administered 15 minutes before, during the 10th minute of, and 15 minutes after the medication application with the toy-figured nebulizer. For the control group, routine inhalation therapy of the service will be applied without any additional intervention. Children in this group will also fill out the Introductory Information Form. Their life signs will be measured similarly by the experienced nurse and recorded on a 'Physical Parameters Form.' The Child Fear Scale and Emotional Indicators in Children Scale will be administered during the 10th minute and 15 minutes after the routine medication application. Due to the nature of the study, blinding during the execution will not be possible; however, to prevent potential bias, measurements will be taken by both the experienced nurse (for physiological parameters, Child Fear Scale, Emotional Indicators in Children Scale) and parents (for Child Fear Scale, Emotional Indicators in Children Scale). Statistical analysis and reporting will be conducted without knowledge of which group is the experimental or control group (coding will be applied).
Data Evaluation:
Data processing and statistical analyses will be performed using Statistical Package for the Social Sciences for Windows 20.0. For measurements not conforming to a normal distribution, non-parametric methods will be utilized. The Kruskal-Wallis H test (χ2-table value) will be used for comparing three or more independent groups. Pearson-χ2 cross-tabulations will be employed to examine the relationships between two qualitative variables. The Spearman correlation coefficient will be used to analyze the relationships between two quantitative variables that do not follow a normal distribution.
Ethical Principles of the Research:
For the execution of the study, official permission has been obtained from the Ethical Committee of the Recep Tayyip Erdogan University Faculty of Medicine. Children eligible for the research group, along with their parents, will be informed about the purpose of the study, and their questions will be answered before obtaining their verbal and written consent. Parents and children will be assured that the data collected during the research will be processed anonymously and confidentially, will not be used outside of this study, and they may withdraw from the study at any time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group: Routine clinical practice | No intervention | –Fear, Emotional Indicators and Physiological Parameters in Children |
| Therapeutic play: Fish-shaped nebulizer and fish-shaped toy | Experimental | Behavioral: Fish-shaped nebulizer and fish-shaped toyFear, Emotional Indicators and Physiological Parameters in Children |
| silent nebulizer | Experimental | Device: Silent nebulizerFear, Emotional Indicators and Physiological Parameters in Children |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Having a child between the ages of 3-6
- Nebulizer and inhaler treatment will be applied
- The child does not have a mental or neurological disability
- Applying due to respiratory system disease
- The presence of the child's mother during the application period
Key exclusion criteria (5 listed)
- The child and parent have previously experienced inhalation therapy with a nebulizer.
- The child is hyperthermic (body temperature is 38 C and above)
- The child has pain,
- The child is in the terminal period,
- The parent has a condition that prevents him/her from evaluating the scale (mental disability, etc.).
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 |
|---|---|---|
| Fish-shaped nebulizer and fish-shaped toyIn order to reduce the child's fear and anxiety, it is planned to apply inhalation therapy using a nebulizer with a red fish figure and an amigurumi toy with a red fish figure. | Behavioural | Therapeutic play: Fish-shaped nebulizer and fish-shaped toy |
| Silent nebulizerIt is planned to apply inhalation therapy using a silent nebulizer to reduce the child's fear and anxiety. | Device | silent nebulizer |
Primary outcome
Child Fear Scale
Time frame: one year
This scale was developed to measure the anxiety levels in children. The facial muscle changes in expressions of fear have been illustrated by a graphic artist based on photographs of frightened faces. The scale can be used by families, children, or researchers to assess children. It presents a scale containing five facial expressions, scored between 0 and 4. A score of 0 indicates no fear or anxiety, while a score of 4 indicates the highest level of fear or anxiety. These are recognized as: "0" neutral expression (no anxiety), "1" very slight fear (very low anxiety), "2" mild fear (mild anxiety), "3" more fear (increased anxiety), "4" the most extreme fear (severe anxiety). This scale can be applied to measure fear and anxiety before and during medical procedures.
Emotional Indicators Scale for Children
Time frame: one year
This scale is an easily administered and evaluated tool used to objectively identify emotional responses of children to medical procedures. The emotional indicators on the scale are assessed based on five parameters: facial expression, voice, activity, interaction, and cooperation level. These five parameters are scored from 1 to 5, with the lowest possible score being 5 and the highest being 25. The scale has a Cronbach's alpha reliability coefficient of 0.88. In this study, the scale will be utilized to assess the emotional indicators of children during inhalation therapy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- 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.
Mehtap METİN KARAASLAN study director
Recep Tayyip Erdogan Universİty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fish-shaped nebulizer and fish-shaped toy and Silent nebulizer in people with Anxiety and Fear, run by Recep Tayyip Erdogan 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 9 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: finished, as of the sponsor's last update on 1 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Fear Scale (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2025.