Lower Respiratory Tract DiseaseNCT06924528
The Effects Of Toy In Chıldren Durıng Inhaler Therapy
A study testing using toy during inhaler treatment in people with Lower Respiratory Tract Disease and Respiratory Disease, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of the study is to investigate the effect of using a toy that children like during inhaler treatment on children's anxiety and emotional state. In the study, an inhaler treatment will be applied to children with a mask placed on a toy that they like. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Respiratory Tract Disease, Respiratory Disease
- What is being tested?
- using toy during inhaler treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2024to 5 Apr 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child being between the ages of 4 and 6,
- The child being scheduled to receive their first inhaler treatment after admission to the unit,
- No IV or IM interventions being performed before the inhaler treatment,
- The child and parents being willing to participate in the study,
- No mental or neurological disabilities present in the child or parent,
- The child not having any life-threatening illnesses,
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- The child having an oxygen saturation of 95% or higher,
- The child's body temperature not exceeding 37.5 degrees Celsius,
- The child's cognitive level and motor development being appropriate for their age,
- The child being able to count up to 10,
- The parent being literate,
- No visual or auditory problems present in the child or parent
Who cannot join
- The child's general condition (tachycardia, fever, vomiting, etc.) and orientation (disorientation, lethargy, etc.) significantly deteriorating after the inhaler treatment begins,
- The parent or child wanting to withdraw from the study at any stage of the research.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr Sadi Konuk Researching and Training Hospital
Istanbul, Istanbul, 34000
About this study
The purpose of the study is to investigate the effect of using a toy that children like during inhaler treatment on children's anxiety and emotional state. In the study, an inhaler treatment will be applied to children with a mask placed on a toy that they like. The purpose of this intervention is to reduce the child's anxiety and increase their emotional adjustment by improving adherence to the treatment.
Read the detailed description
Respiratory diseases are commonly seen during childhood. Today, inhaler medication is frequently used in the treatment of lower respiratory tract diseases. Inhalation therapy is the process of delivering liquid medication in aerosol form directly to the respiratory tract and lungs using devices called nebulizers. Compared to other treatment methods, the direct delivery of medication to the lungs, the rapid onset of effect, and fewer systemic side effects make inhalation therapy the preferred method for treating children. In treatments administered through inhalation, if the inhalation is being applied for the first time, the child may experience fear and anxiety due to not knowing the procedure. After the nurse explains how the procedure is done, they should use distraction techniques to relax the child and support the effective continuation of the inhalation treatment. Distraction techniques are simple and inexpensive methods, and studies have proven their positive effect on children. This study is designed to investigate the effect of using a toy during inhaler treatment on children's anxiety and emotional state.
- Being tested
- using toy during inhaler treatment
- Keywords
- children, inhalation therapy, toy, anxiety, emotional state
- Medical subject headings
- Respiration Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using toy during inhaler treatmentOther
Also called using toy
The mask application on the toy will be performed only during the first inhaler treatment that the children receive in the emergency department.
| Study group | Role | What they receive |
|---|---|---|
| The control group | No intervention | 5 minutes before starting the inhaler treatment, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. After washing hands, the aerosol medication ordered by the physician should be applied using a nebulizer mask. In the 5th minute after the inhaler treatment begins, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. 5 minutes after the inhaler treatment ends, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. |
| The intervention group | Experimental | 5 minutes before starting the inhaler treatment, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers.
After washing hands, the aerosol medication ordered by the physician should be applied using a nebulizer mask.
The child is introduced to the plush toy of Kral Şakir, a character they recognize from cartoons. After explaining that King Şakir also needs help to recover, the nebulizer mask is applied to the toy, and saline solution is added to the mask's reservoir. Then, the treatment is started together with the child.
In the 5th minute after the inhaler treatment begins, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers.
5 minutes after the inhaler treatment ends, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. Receives: Other: using toy during inhaler treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
children's anxiety meter state
To measure state anxiety, children are asked to mark how they feel "right now." To measure trait anxiety, another copy of the scale is presented, and they are asked to mark how they "usually feel at home." Examples of being at home are provided to the children, like "think about when you were playing outside with a friend" and "think about sitting quietly watching TV." Before completing the scale, children were screened for their ability to rank order by size. They were asked to count to 10, and then answer, "Which is bigger, 7 or 4?" Children were also asked to identify the smallest of a series of four stacking cups. Children unable to complete these tasks successfully or who did not understand the instructions did not complete the scale.
Measured: five months
Secondary outcomes (1)
Children's Emotional Manifestation Scale
In the scale, emotional indicators are evaluated based on five parameters. These parameters are: facial expression, voice, activity, interaction, and cooperation level. Each of these five parameters is scored on a scale from 1 to 5, with the lowest possible score being "5" and the highest possible score being "25."
In the first category, facial expression, the child's facial expressions observed by the researcher are scored on 5 items.
Secondly, in the vocalization category, the child's tearfulness is evaluated through 5 sub-items.
Thirdly, in the movement category, scoring is done based on the child's body language, using 5 sub-items.
Fourthly, in the interaction category, the child's verbal and non-verbal communication is evaluated through 5 sub-items.
Finally, in the cooperation category, the child's active or passive participation is observed and scored based on 5 sub-items.
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start2 Nov 2024
- Primary completion26 Mar 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract DiseaseStudies 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
- The intervention group received the mask application on the toy. The control group did not receive the mask application on the toy.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Boke, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06924528
- Sponsor's protocol ID
- BakırköySadiKonuk-aboke-01
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2025
- Last updated
- 15 Apr 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Toy In Chıldren Durıng Inhaler Therapy
- ClinicalTrials.gov ID
- NCT06924528
- Acronym / sponsor ID
- BakırköySadiKonuk-aboke-01
- Keywords
- children, inhalation therapy, toy, anxiety, emotional state
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 2 Nov 2024 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 11 Apr 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 purpose of the study is to investigate the effect of using a toy that children like during inhaler treatment on children's anxiety and emotional state. In the study, an inhaler treatment will be applied to children with a mask placed on a toy that they like. The purpose of this intervention is to reduce the child's anxiety and increase their emotional adjustment by improving adherence to the treatment.
Detailed description
Respiratory diseases are commonly seen during childhood. Today, inhaler medication is frequently used in the treatment of lower respiratory tract diseases. Inhalation therapy is the process of delivering liquid medication in aerosol form directly to the respiratory tract and lungs using devices called nebulizers. Compared to other treatment methods, the direct delivery of medication to the lungs, the rapid onset of effect, and fewer systemic side effects make inhalation therapy the preferred method for treating children. In treatments administered through inhalation, if the inhalation is being applied for the first time, the child may experience fear and anxiety due to not knowing the procedure. After the nurse explains how the procedure is done, they should use distraction techniques to relax the child and support the effective continuation of the inhalation treatment. Distraction techniques are simple and inexpensive methods, and studies have proven their positive effect on children. This study is designed to investigate the effect of using a toy during inhaler treatment on children's anxiety and emotional state.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The intervention group received the mask application on the toy. The control group did not receive the mask application on the toy.
| Arm | Type | Receives |
|---|---|---|
| The control group | No intervention | –5 minutes before starting the inhaler treatment, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. After washing hands, the aerosol medication ordered by the physician should be applied using a nebulizer mask. In the 5th minute after the inhaler treatment begins, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. 5 minutes after the inhaler treatment ends, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. |
| The intervention group | Experimental | Other: using toy during inhaler treatment5 minutes before starting the inhaler treatment, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. After washing hands, the aerosol medication ordered by the physician should be applied using a nebulizer mask. The child is introduced to the plush toy of Kral Şakir, a character they recognize from cartoons. After explaining that King Şakir also needs help to recover, the nebulizer mask is applied to the toy, and saline solution is added to the mask's reservoir. Then, the treatment is started together with the child. In the 5th minute after the inhaler treatment begins, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. 5 minutes after the inhaler treatment ends, the child's anxiety level should be determined, and the child's emotional state should be evaluated by two observers. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- The child being between the ages of 4 and 6,
- The child being scheduled to receive their first inhaler treatment after admission to the unit,
- No IV or IM interventions being performed before the inhaler treatment,
- The child and parents being willing to participate in the study,
- No mental or neurological disabilities present in the child or parent,
Key exclusion criteria (2 listed)
- The child's general condition (tachycardia, fever, vomiting, etc.) and orientation (disorientation, lethargy, etc.) significantly deteriorating after the inhaler treatment begins,
- The parent or child wanting to withdraw from the study at any stage of the research.
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 |
|---|---|---|
| using toy during inhaler treatmentAlso: using toyThe mask application on the toy will be performed only during the first inhaler treatment that the children receive in the emergency department. | Other | The intervention group |
Primary outcome
children's anxiety meter state
Time frame: five months
To measure state anxiety, children are asked to mark how they feel "right now." To measure trait anxiety, another copy of the scale is presented, and they are asked to mark how they "usually feel at home." Examples of being at home are provided to the children, like "think about when you were playing outside with a friend" and "think about sitting quietly watching TV." Before completing the scale, children were screened for their ability to rank order by size. They were asked to count to 10, and then answer, "Which is bigger, 7 or 4?" Children were also asked to identify the smallest of a series of four stacking cups. Children unable to complete these tasks successfully or who did not understand the instructions did not complete the scale.
1 secondary outcome
Children's Emotional Manifestation Scale
Time frame: five months
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 15 Apr 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.
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 using toy during inhaler treatment in people with Lower Respiratory Tract Disease and Respiratory Disease, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 12 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: finished, as of the sponsor's last update on 15 Apr 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?
children's anxiety meter state (time frame: five months). 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 15 Apr 2025.