ChildNCT06510166
The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety: : Randomize Controlled Study
A study testing Children's Fear and Anxiety normal nebulizer and mask+ distraction and Children's Fear and Anxiety a toy nebulizer and a toy mask in people with Child and Inhalation Therapy; Complications, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
It was aimed to examine the effects of distraction methods used during inhalation therapy on children's fear and anxiety. Hypothesis: Hypothesis 0 (H0): There is no difference between the fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques and toy type nebulizer + toy mask… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Child, Inhalation Therapy; Complications, Fear
- What is being tested?
- Children's Fear and Anxiety normal nebulizer and mask+ distraction and Children's Fear and Anxiety a toy nebulizer and a toy mask
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2024to 8 Dec 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
- Parent and child volunteer to participate in the study,
- The child is between 3-6 years old,
- Presentation due to upper and lower respiratory tract infection,
- Inhaler treatment will be applied with a nebulizer,
- No request for any other intravenous, intramuscular or invasive treatment,
- The child does not have any genetic, congenital, chronic or metabolic disease,
Who cannot join
- Parent and child are not willing to participate in the study,
- The child is not between 3-6 years old,
- Presentation for a reason other than upper and lower respiratory tract infection,
- No inhaler treatment with a nebulizer,
- Request for any other intravenous, intramuscular or invasive treatment,
- The child has any genetic, congenital, chronic or metabolic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University
Samsun, Atakum, 55139
About this study
Official title: The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety: A Randomized Controlled Study
It was aimed to examine the effects of distraction methods used during inhalation therapy on children's fear and anxiety.
Hypothesis:
Read more
Hypothesis 0 (H0): There is no difference between the fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques and toy type nebulizer + toy mask during inhaler treatment and the children in the control group.
Hypothesis 1 (H1): The fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques during inhaler treatment are lower than the children in the control group.
Hypothesis 2 (H2): The fear and anxiety levels of children who were applied a toy type nebulizer + toy mask during inhaler treatment are lower than the children in the control group.
Hypothesis 3 (H3): The fear and anxiety levels of children who were treated with a toy type nebulizer + toy mask during inhaler treatment were lower than those of children who were treated with a normal nebulizer + mask + distraction techniques.
Read the detailed description
In the literature, distraction techniques are generally used in invasive procedures. On the other hand, it is possible that studies on the effects of inhalation therapy and non-pharmacological methods, which are among the common non-invasive interventions in children, can still continue. Durak et al. (2021) stated that the developments in experimental groups, in which they were made to watch cartoons during inhalation treatment, were lower in adults than in control groups and in children. A similar study was published by Ozsamuri (2020), and children receiving mask and inhaler treatment consisted of watching cartoons, listening to music, and a control group. As a result of the study, intra-group comparisons show that the fear and anxiety scores of people in cartoon and music groups decreased compared to before the procedure . However, arranging emergency services for children and selling them with treatment materials have been shown to be effective in reducing children's fears. Negative reactions to the growth mask and nebulizer during inhaler therapy, causing incorrect inhalation patterns, and deterioration are reduced. Yanık and Ayyıldız (2019) conducted a study on the effectiveness of the training given with a toy-type nebulizer for children aged 3-6 years who received nebulizer therapy. During the therapy inhaler treatment, the scores of the people in the experimental group decreased, while the scores of the control group increased. Kırkan (2023) stated that the therapeutic play method applied with toy nebulizers and toy nebulizers in the activities he conducted with 3-8 year old children who received nebulizers is an effective method treatment in reducing fear and anxiety in the children's hospital. Distracting methods during inhaler treatment for children are beneficial for patients to have positive hospital experiences. This will reduce patients' fear of the hospital, prevent providers from experiencing stress, and ensure that people are satisfied. Adequate information during treatment procedures in children will improve fear, pain and anxiety management and increase the positive hospital experience. Rapid healing is important because of the reduced use of treatment materials, the effectiveness of human resources, and the increase in health knowledge.
- Conditions
- Child, Inhalation Therapy; Complications, Fear, Distraction Methods, Anxiety
- Being tested
- Children's Fear and Anxiety normal nebulizer and mask+ distraction, Children's Fear and Anxiety a toy nebulizer and a toy mask
- Keywords
- child, inhalation theraphy, fear, distraction methods, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children's Fear and Anxiety normal nebulizer and mask+ distractionBehavioural
Children in group 2 will receive their inhaler treatment with a normal nebulizer and mask, while at the same time one of the distraction techniques of their choice (drawing a picture, reading a story or watching an age-appropriate cartoon) will be applied.
Children's Fear and Anxiety a toy nebulizer and a toy maskBehavioural
Children in Group 3 will receive their inhaler treatment using a toy nebulizer and a toy mask.
| Study group | Role | What they receive |
|---|---|---|
| normal nebulizer + mask + distraction technique | Experimental | Inclusion criteria is below:
1. Parent and child volunteer to participate in the study,
2. The child is between 3-6 years old,
3. Presentation due to upper and lower respiratory tract infection,
4. Inhaler treatment will be applied with a nebulizer,
5. No request for any other intravenous, intramuscular or invasive treatment,
6. The child does not have any genetic, congenital, chronic or metabolic disease Receives: Behavioral: Children's Fear and Anxiety normal nebulizer and mask+ distraction |
| toy type nebulizer + toy mask | Active comparator | Inclusion criteria is below:
1. Parent and child volunteer to participate in the study,
2. The child is between 3-6 years old,
3. Presentation due to upper and lower respiratory tract infection,
4. Inhaler treatment will be applied with a nebulizer,
5. No request for any other intravenous, intramuscular or invasive treatment,
6. The child does not have any genetic, congenital, chronic or metabolic disease Receives: Behavioral: Children's Fear and Anxiety a toy nebulizer and a toy mask |
| control group | No intervention | Inclusion criteria is below: 1. Parent and child volunteer to participate in the study, 2. The child is between 3-6 years old, 3. Presentation due to upper and lower respiratory tract infection, 4. Inhaler treatment will be applied with a nebulizer, 5. No request for any other intravenous, intramuscular or invasive treatment, 6. The child does not have any genetic, congenital, chronic or metabolic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
changing the anxiety
Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.
Measured: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'
changing the fear
Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.
Measured: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start8 Apr 2024
- Primary completion8 Oct 2025
- Study completion8 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs 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, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Koyun, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510166
- Sponsor's protocol ID
- OndokusMK
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: other researchers may view the study once it is published.
Publications
Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018.
PubMed 33742204Kirkan C, Kahraman A. Effect of therapeutic play using a toy nebulizer and toy mask on a child's fear and anxiety levels. J Pediatr Nurs. 2023 Nov-Dec;73:e556-e562. doi: 10.1016/j.pedn.2023.10.033. Epub 2023 Nov 7.
PubMed 37940393
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distraction Methods Used During Inhalation Therapy on Children's Fear and Anxiety: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06510166
- Acronym / sponsor ID
- OndokusMK
- Conditions
- Child, Inhalation Therapy; Complications, Fear, Distraction Methods, Anxiety
- Keywords
- child, inhalation theraphy, fear, distraction methods, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 8 Dec 2025 (actual)
- First posted
- 19 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.
It was aimed to examine the effects of distraction methods used during inhalation therapy on children's fear and anxiety.
Hypothesis:
Hypothesis 0 (H0): There is no difference between the fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques and toy type nebulizer + toy mask during inhaler treatment and the children in the control group.
Hypothesis 1 (H1): The fear and anxiety levels of children who received normal nebulizer + mask + distraction techniques during inhaler treatment are lower than the children in the control group.
Hypothesis 2 (H2): The fear and anxiety levels of children who were applied a toy type nebulizer + toy mask during inhaler treatment are lower than the children in the control group.
Hypothesis 3 (H3): The fear and anxiety levels of children who were treated with a toy type nebulizer + toy mask during inhaler treatment were lower than those of children who were treated with a normal nebulizer + mask + distraction techniques.
Detailed description
In the literature, distraction techniques are generally used in invasive procedures. On the other hand, it is possible that studies on the effects of inhalation therapy and non-pharmacological methods, which are among the common non-invasive interventions in children, can still continue. Durak et al. (2021) stated that the developments in experimental groups, in which they were made to watch cartoons during inhalation treatment, were lower in adults than in control groups and in children. A similar study was published by Ozsamuri (2020), and children receiving mask and inhaler treatment consisted of watching cartoons, listening to music, and a control group. As a result of the study, intra-group comparisons show that the fear and anxiety scores of people in cartoon and music groups decreased compared to before the procedure . However, arranging emergency services for children and selling them with treatment materials have been shown to be effective in reducing children's fears. Negative reactions to the growth mask and nebulizer during inhaler therapy, causing incorrect inhalation patterns, and deterioration are reduced. Yanık and Ayyıldız (2019) conducted a study on the effectiveness of the training given with a toy-type nebulizer for children aged 3-6 years who received nebulizer therapy. During the therapy inhaler treatment, the scores of the people in the experimental group decreased, while the scores of the control group increased. Kırkan (2023) stated that the therapeutic play method applied with toy nebulizers and toy nebulizers in the activities he conducted with 3-8 year old children who received nebulizers is an effective method treatment in reducing fear and anxiety in the children's hospital. Distracting methods during inhaler treatment for children are beneficial for patients to have positive hospital experiences. This will reduce patients' fear of the hospital, prevent providers from experiencing stress, and ensure that people are satisfied. Adequate information during treatment procedures in children will improve fear, pain and anxiety management and increase the positive hospital experience. Rapid healing is important because of the reduced use of treatment materials, the effectiveness of human resources, and the increase in health knowledge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal nebulizer + mask + distraction technique | Experimental | Behavioral: Children's Fear and Anxiety normal nebulizer and mask+ distractionInclusion criteria is below: 1. Parent and child volunteer to participate in the study, 2. The child is between 3-6 years old, 3. Presentation due to upper and lower respiratory tract infection, 4. Inhaler treatment will be applied with a nebulizer, 5. No request for any other intravenous, intramuscular or invasive treatment, 6. The child does not have any genetic, congenital, chronic or metabolic disease |
| toy type nebulizer + toy mask | Active comparator | Behavioral: Children's Fear and Anxiety a toy nebulizer and a toy maskInclusion criteria is below: 1. Parent and child volunteer to participate in the study, 2. The child is between 3-6 years old, 3. Presentation due to upper and lower respiratory tract infection, 4. Inhaler treatment will be applied with a nebulizer, 5. No request for any other intravenous, intramuscular or invasive treatment, 6. The child does not have any genetic, congenital, chronic or metabolic disease |
| control group | No intervention | –Inclusion criteria is below: 1. Parent and child volunteer to participate in the study, 2. The child is between 3-6 years old, 3. Presentation due to upper and lower respiratory tract infection, 4. Inhaler treatment will be applied with a nebulizer, 5. No request for any other intravenous, intramuscular or invasive treatment, 6. The child does not have any genetic, congenital, chronic or metabolic disease |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parent and child volunteer to participate in the study,
- The child is between 3-6 years old,
- Presentation due to upper and lower respiratory tract infection,
- Inhaler treatment will be applied with a nebulizer,
- No request for any other intravenous, intramuscular or invasive treatment,
Key exclusion criteria (6 listed)
- Parent and child are not willing to participate in the study,
- The child is not between 3-6 years old,
- Presentation for a reason other than upper and lower respiratory tract infection,
- No inhaler treatment with a nebulizer,
- Request for any other intravenous, intramuscular or invasive treatment,
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 |
|---|---|---|
| Children's Fear and Anxiety normal nebulizer and mask+ distractionChildren in group 2 will receive their inhaler treatment with a normal nebulizer and mask, while at the same time one of the distraction techniques of their choice (drawing a picture, reading a story or watching an age-appropriate cartoon) will be applied. | Behavioural | normal nebulizer + mask + distraction technique |
| Children's Fear and Anxiety a toy nebulizer and a toy maskChildren in Group 3 will receive their inhaler treatment using a toy nebulizer and a toy mask. | Behavioural | toy type nebulizer + toy mask |
Primary outcome
changing the anxiety
Time frame: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'
Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.
changing the fear
Time frame: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'
Children's Anxiety Meter- State (CAM-S) is designed like a thermometer, featuring a bulb at its base and horizontal markers at regular intervals as it ascends. Children are asked to represent their feelings on this scale by marking where they stand "right now". They are instructed, "Imagine that all your anxious or angry feelings are on the bulb or bottom part of the thermometer. If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are." This scale provides scores ranging from 0 to 10. As the score increases, the level of anxiety increases.
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 28 Jul 2026.
- Background: PubMed 33742204Durak H, Uysal G. The Effect of Cartoon Watching and Distraction Card on Physiologic Parameters and Fear Levels During Inhalation Therapy in Children: A Randomized Controlled Study. J Trop Pediatr. 2021 Jan 29;67(1):fmab018. doi: 10.1093/tropej/fmab018.
- Background: PubMed 37940393Kirkan C, Kahraman A. Effect of therapeutic play using a toy nebulizer and toy mask on a child's fear and anxiety levels. J Pediatr Nurs. 2023 Nov-Dec;73:e556-e562. doi: 10.1016/j.pedn.2023.10.033. Epub 2023 Nov 7.
- Individual participant dataSharing planned: No. other researchers may view the study once it is published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Children's Fear and Anxiety normal nebulizer and mask+ distraction and Children's Fear and Anxiety a toy nebulizer and a toy mask in people with Child and Inhalation Therapy; Complications, run by Ondokuz Mayıs 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 6 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 28 Jul 2026. 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?
changing the anxiety (time frame: 'Before inhalation theraphy within 5 minutes', 'During inhalation theraphy' and 'After inhalation theraphy within 5 minutes'). 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?
On the ClinicalTrials.gov record for NCT06510166, which also lists 2 linked publications.
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 28 Jul 2026.