Fear AnxietyNCT06874491
Inhalation Treatment Distraction in Children
A study testing Moving and 3D Book and Hand Puppet in people with Fear Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the project is to examine the effects of two different distraction methods used in preschool children receiving inhalation therapy on fear and anxiety levels. Children are exposed to various hospital procedures throughout their lives. These procedures cause children to experience fear, pain and anxiety. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear Anxiety
- What is being tested?
- Moving and 3D Book and Hand Puppet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 25 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- -Being between 4-6 years old
- Not having a developmental disability
- Not having a history of sedative, analgesic or narcotic substance use within 24 hours before application
- Receiving inhalation therapy for the first time
- Not having a chronic disease
- Children who are accompanied by their mother or father during the procedure will be included in the study.
Who cannot join
- Being under 4 years old or over 6 years old
- having a chronic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University Nursing of Faculty
Erzurum
ARZU SARIALİOGLU, 04422315795, arzu.celebi@atauni.edu.tr
About this study
Official title: Effects of Two Different Distraction Methods on Fear and Anxiety Levels in Preschool Children Receiving Inhalation Treatment
The aim of the project is to examine the effects of two different distraction methods used in preschool children receiving inhalation therapy on fear and anxiety levels. Children are exposed to various hospital procedures throughout their lives. These procedures cause children to experience fear, pain and anxiety. One of these procedures is inhalation therapy. When children wear the face masks required for inhalation, they experience intense fear and anxiety. Non-pharmacological techniques are used for the effective management of this fear and anxiety. Among these techniques, distraction is the easy-to-apply. When applying distraction techniques, the child's developmental period, age group and interest should be taken into consideration. The project is a randomized controlled trial. The universe of the study will consist of children between the ages of 4-6 who received inhalation therapy for the first time in the pediatric emergency department of Erzincan Mengücek Gazi Education and Research Hospital between September 2025 and September 2026. In collecting the research data, "Questionnaire Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used.
The two different methods to be used will be designed to attract the attention and interest of the age groups of the children to be included in the research. In this way, it is thought that the child will focus his/her attention and curiosity on the two different methods to be used and the level of fear and anxiety will be affected during the inhalation treatment. This will increase the child's compliance and cooperation with the treatment and will encourage the child.
When the international and national literature was scanned, no study was found that investigated the effects of the two different distraction methods covered in the research during inhalation treatment. With the two different distraction methods to be used, inhalation treatment, which is a source of fear and anxiety for children, will become fun.
Read the detailed description
Children are exposed to various hospital procedures throughout their lives. These procedures cause children to experience fear, pain and anxiety. One of these procedures is inhalation therapy. When children wear the face masks required for inhalation, they experience intense fear and anxiety. Non-pharmacological techniques are used for the effective management of this fear and anxiety. Among these techniques, distraction is the easy-to-apply. When applying distraction techniques, the child's developmental period, age group and interest should be taken into consideration. The project is a randomized controlled trial. The universe of the study will consist of children between the ages of 4-6 who received inhalation therapy for the first time in the pediatric emergency department of Erzincan Mengücek Gazi Education and Research Hospital between September 2025 and September 2026. In collecting the research data, "Questionnaire Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used.
Movable and 3D book: Movable and 3D book that will be suitable and specially designed for inhalation therapy will be used. The book will include materials that children frequently encounter in inhalation therapy (mask, nebulizer, drug models used for treatment, a model of the nurse administering the treatment, and a model of the environment where inhalation therapy is performed). The book is aimed to attract children's attention by being made in an animated and three-dimensional form. The prepared book is presented to the opinions of experts in the field of child health and improvements will be made in line with the feedback. The final version of the book, which is specially designed and suitable for inhalation therapy, will be converted into two different formats and made ready for use in research. The aim of preparing it in two formats is to increase the child's interest in the book by giving him the right to choose. It is thought that this innovative book will have significant effects on children's fear and anxiety levels.
Hand Puppet: A hand puppet that is specially designed for inhalation therapy will be used. Hand puppets that aim to make inhalation therapy fun will be prepared (by playing with children the situations of different characters receiving inhalation therapy in the form of a game). The hand puppets that will be designed with the researcher, preschool teacher and child development specialist who receive play therapy will be prepared in a hypoallergenic form. In order to provide children with the right to choose, different forms will be prepared and children's ideas will be given importance. It is thought that the hand puppet that is specially designed for inhalation therapy will have significant effects on children's fear and anxiety levels.
- Conditions
- Fear Anxiety
- Being tested
- Moving and 3D Book, Hand Puppet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moving and 3D BookBehavioural
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a moving and 3D book that will be specially designed for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled out again. Filling out the forms will take an average of 5-10 minutes.
Hand PuppetBehavioural
After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a hand puppet that will be specially designed for inhalation treatment by the researcher. After the treatment is completed.
| Study group | Role | What they receive |
|---|---|---|
| Moving and 3D Book Group | Experimental | After the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled. During the inhaler treatment, the researcher will ensure that the child spends time with a moving and 3D book that will be specially designed and suitable for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes. Receives: Behavioral: Moving and 3D Book |
| Hand Puppet Group | Experimental | After the data collector is taken to the environment where the child will receive inhalation treatment, the child and parent will be introduced and the purpose of the study will be explained and the scales will be filled. During the inhaler treatment, the researcher will ensure that the child spends time with a hand puppet that will be specially designed and suitable for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes. Receives: Behavioral: Hand Puppet |
| Control Group | No intervention | The data collector will be taken to the environment where the child will receive inhalation treatment and the routine procedures will be continued. Then, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale
The Child Fear Scale was developed by McMurty and colleagues in 2011 to measure fear in children undergoing painful medical procedures. The Turkish validity and reliability of the scale was performed by Özalp Gerçeker and colleagues in 2018. The Child Fear Scale is a 0-4 scale showing five faces ranging from a neutral expression (0 = no anxiety at all) to the feared face (4 = severe anxiety).
Measured: 1 YEAR
Child Anxiety Scale-State
The scale, developed by Ersig and his colleagues in 2013, was validated in Turkish by Özalp Gerçeker and his colleagues in 2018. The "Children's Anxiety Scale-State, which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4 to 10. When the scale is introduced to the child, it is said that there is no anxiety, that anxiety increases as it goes up, and that the anxiety level is very high at the top. The child is then asked to draw a line in the section that shows how anxious or nervous he is.
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start1 Sep 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion25 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear AnxietyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874491
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/136
- Status last verified
- Mar 2025
- First submitted
- 8 Mar 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Different Distraction Methods on Fear and Anxiety Levels in Preschool Children Receiving Inhalation Treatment
- ClinicalTrials.gov ID
- NCT06874491
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/136
- Conditions
- Fear Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 25 Sep 2026 (estimated)
- First posted
- 13 Mar 2025 (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 aim of the project is to examine the effects of two different distraction methods used in preschool children receiving inhalation therapy on fear and anxiety levels. Children are exposed to various hospital procedures throughout their lives. These procedures cause children to experience fear, pain and anxiety. One of these procedures is inhalation therapy. When children wear the face masks required for inhalation, they experience intense fear and anxiety. Non-pharmacological techniques are used for the effective management of this fear and anxiety. Among these techniques, distraction is the easy-to-apply. When applying distraction techniques, the child's developmental period, age group and interest should be taken into consideration. The project is a randomized controlled trial. The universe of the study will consist of children between the ages of 4-6 who received inhalation therapy for the first time in the pediatric emergency department of Erzincan Mengücek Gazi Education and Research Hospital between September 2025 and September 2026. In collecting the research data, "Questionnaire Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used.
The two different methods to be used will be designed to attract the attention and interest of the age groups of the children to be included in the research. In this way, it is thought that the child will focus his/her attention and curiosity on the two different methods to be used and the level of fear and anxiety will be affected during the inhalation treatment. This will increase the child's compliance and cooperation with the treatment and will encourage the child.
When the international and national literature was scanned, no study was found that investigated the effects of the two different distraction methods covered in the research during inhalation treatment. With the two different distraction methods to be used, inhalation treatment, which is a source of fear and anxiety for children, will become fun.
Detailed description
Children are exposed to various hospital procedures throughout their lives. These procedures cause children to experience fear, pain and anxiety. One of these procedures is inhalation therapy. When children wear the face masks required for inhalation, they experience intense fear and anxiety. Non-pharmacological techniques are used for the effective management of this fear and anxiety. Among these techniques, distraction is the easy-to-apply. When applying distraction techniques, the child's developmental period, age group and interest should be taken into consideration. The project is a randomized controlled trial. The universe of the study will consist of children between the ages of 4-6 who received inhalation therapy for the first time in the pediatric emergency department of Erzincan Mengücek Gazi Education and Research Hospital between September 2025 and September 2026. In collecting the research data, "Questionnaire Form", "Child Fear Scale" and "Child Anxiety Scale-State" will be used.
Movable and 3D book: Movable and 3D book that will be suitable and specially designed for inhalation therapy will be used. The book will include materials that children frequently encounter in inhalation therapy (mask, nebulizer, drug models used for treatment, a model of the nurse administering the treatment, and a model of the environment where inhalation therapy is performed). The book is aimed to attract children's attention by being made in an animated and three-dimensional form. The prepared book is presented to the opinions of experts in the field of child health and improvements will be made in line with the feedback. The final version of the book, which is specially designed and suitable for inhalation therapy, will be converted into two different formats and made ready for use in research. The aim of preparing it in two formats is to increase the child's interest in the book by giving him the right to choose. It is thought that this innovative book will have significant effects on children's fear and anxiety levels.
Hand Puppet: A hand puppet that is specially designed for inhalation therapy will be used. Hand puppets that aim to make inhalation therapy fun will be prepared (by playing with children the situations of different characters receiving inhalation therapy in the form of a game). The hand puppets that will be designed with the researcher, preschool teacher and child development specialist who receive play therapy will be prepared in a hypoallergenic form. In order to provide children with the right to choose, different forms will be prepared and children's ideas will be given importance. It is thought that the hand puppet that is specially designed for inhalation therapy will have significant effects on children's fear and anxiety levels.
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 |
|---|---|---|
| Moving and 3D Book Group | Experimental | Behavioral: Moving and 3D BookAfter the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled. During the inhaler treatment, the researcher will ensure that the child spends time with a moving and 3D book that will be specially designed and suitable for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes. |
| Hand Puppet Group | Experimental | Behavioral: Hand PuppetAfter the data collector is taken to the environment where the child will receive inhalation treatment, the child and parent will be introduced and the purpose of the study will be explained and the scales will be filled. During the inhaler treatment, the researcher will ensure that the child spends time with a hand puppet that will be specially designed and suitable for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes. |
| Control Group | No intervention | –The data collector will be taken to the environment where the child will receive inhalation treatment and the routine procedures will be continued. Then, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled again. Filling out the forms will take approximately 5-10 minutes. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- -Being between 4-6 years old
- Not having a developmental disability
- Not having a history of sedative, analgesic or narcotic substance use within 24 hours before application
- Receiving inhalation therapy for the first time
- Not having a chronic disease
Key exclusion criteria (2 listed)
- Being under 4 years old or over 6 years old
- having a chronic disease
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 |
|---|---|---|
| Moving and 3D BookAfter the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a moving and 3D book that will be specially designed for inhalation treatment. After the treatment is completed, the child's reactions will be evaluated and the scales will be filled out again. Filling out the forms will take an average of 5-10 minutes. | Behavioural | Moving and 3D Book Group |
| Hand PuppetAfter the data collector is taken to the environment where the child will receive inhalation treatment, the child and the parent will be introduced and the purpose of the study will be explained and the scales will be filled out. During the inhaler treatment, the child will spend time with a hand puppet that will be specially designed for inhalation treatment by the researcher. After the treatment is completed. | Behavioural | Hand Puppet Group |
Primary outcome
Child Fear Scale
Time frame: 1 YEAR
The Child Fear Scale was developed by McMurty and colleagues in 2011 to measure fear in children undergoing painful medical procedures. The Turkish validity and reliability of the scale was performed by Özalp Gerçeker and colleagues in 2018. The Child Fear Scale is a 0-4 scale showing five faces ranging from a neutral expression (0 = no anxiety at all) to the feared face (4 = severe anxiety).
Child Anxiety Scale-State
Time frame: 1 YEAR
The scale, developed by Ersig and his colleagues in 2013, was validated in Turkish by Özalp Gerçeker and his colleagues in 2018. The "Children's Anxiety Scale-State, which resembles a thermometer with horizontal lines, is scored from 0 to 10. It is a scale developed for children aged 4 to 10. When the scale is introduced to the child, it is said that there is no anxiety, that anxiety increases as it goes up, and that the anxiety level is very high at the top. The child is then asked to draw a line in the section that shows how anxious or nervous he is.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moving and 3D Book and Hand Puppet in people with Fear Anxiety, run by Ataturk 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 2 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: looking for participants now, as of the sponsor's last update on 7 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ARZU SARIALIOGLU (04422315795, arzu.celebi@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Fear Scale (time frame: 1 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 7 Oct 2025.