NEBULIZATIONNCT06755918
Video Games and Mask Painting on During Nebulizer Application in Children
A study testing Video game and Mask painting in people with NEBULIZATION and Children, run by Semra Kose at 1 site in Turkey (Türkiye).
Trial summary
The clinical features of respiratory system diseases seen in childhood are generally moderate and improve in a short time. Respiratory system diseases are divided into two as upper respiratory system diseases and lower respiratory system diseases. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- NEBULIZATION, Children
- What is being tested?
- Video game and Mask painting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Dec 2024to 15 Jun 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between the ages of 7-12
- Receiving the first nebulization treatment after hospitalization
- Able to speak and read Turkish
- Receiving nebulizer treatment
- Children who agree to participate in the study and children whose parents agree to participate in the study
Who cannot join
- Those who are allergic to paint
- Those who have a chronic disease and routinely use a nebulizer
- Those who are connected to any respiratory device (mechanical, etc.)
- Those who did not complete the intervention and wish to withdraw from the study
- Those who have any body function deficiency that prevents coloring or tablet games
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Video Games and Mask Painting on Anxiety and Treatment Compliance During Nebulizer Application in Children: Randomized Controlled Study
The clinical features of respiratory system diseases seen in childhood are generally moderate and improve in a short time. Respiratory system diseases are divided into two as upper respiratory system diseases and lower respiratory system diseases. The respiratory tract, from the mouth and nose, which are the upper respiratory tract, to the glottis (nasal mucosa, nasopharynx, oropharynx, sinuses, middle ear tonsils and epiglottis) and the infections that occur in these sections are called upper respiratory tract infections (URTI). Lower respiratory system diseases are considered as tuberculosis, asthma, cystic fibrosis and bronchopulmonary dysplasia. The most common diseases in children are respiratory tract diseases. The diseases that are considered as priorities for each age group vary. According to the Turkish Thoracic Society, the incidence of lower respiratory tract infections (LRTI) between the ages of 0-5 is 29%. According to TUIK 2022 data, upper respiratory tract infections are the most common infectious diseases experienced by children between the ages of 0-6 with a rate of 31.3%, and lower respiratory tract infections are the third with a rate of 6.9%. In children between the ages of 7-14, upper respiratory tract infections are the most common with a rate of 27.1%, and lower respiratory tract infections are the third with a rate of 5.3%.
Read the detailed description
The treatment of respiratory system diseases includes maintaining airway patency, using antibiotics and corticosteroids, and oxygen support. The most preferred is bronchodilator - vasoconstriction and bronchodilation (nebule therapy). Nebulizer use reduces symptoms by reducing wheezing, shortness of breath, and edema in the respiratory tract, and therapeutics (saline fluids, bronchodilators, epinephrine, anticholinergic agents, and corticosteroids) used are used as a treatment option. The use of nebulizer drugs is used as an emergency treatment method in both children and adults, especially in respiratory system diseases, all over the world and in Turkey. In addition, their use in the treatment of lung diseases is increasing. The main purpose of inhalation treatment is to send smaller amounts of medication directly to the respiratory tract as soon as possible, to deliver drug particles to the farthest lobes of the lungs, to eliminate airway stenosis in the respiratory system and to regulate the amount of mucus.
In children, the process of hospitalization, treatment, and the devices used can be traumatic. Many devices used in the hospital, such as the use of nebulizers, the sounds of the devices, unfamiliar people, unfamiliar environments, dependence on caregivers, unfamiliar tools and equipment, traumatic and painful invasive procedures, separation from family and friends, disruption of routines such as sleep, eating, playing, and school can affect children's anxiety levels and compliance with treatment. The pain and suffering they experience during procedures can be reduced by using distraction methods. One of the distraction methods is therapeutic play. Therapeutic play should be used as an effective method to minimize the negative effects of procedures and to support the child in developing effective coping methods. It has been observed in literature studies that children who use nebulizers together with therapeutic play have decreased fear, pain, anxiety and stress levels. In the study conducted by Kırkan et al. (2023), it was observed that nebulizer treatment with a toy nebulizer and a toy mask decreased children's anxiety levels. In another study conducted by Kurtuncu et al. (2019), it was observed that 3-dimensional nebulizer treatment reduced psychosocial symptoms seen in children. In another study, it was determined that education given with a toy-type nebulizer reduced anxiety levels in children. Therapeutic play allows effective cooperation with the child by understanding the child's behavior. Therapeutic play has an important measure in ensuring that children comply with treatment, display positive behavior, and improve care. This study, which can be easily applied by nurses in the hospital environment before, during, and after medical, invasive procedures, will also ensure children's compliance with treatment and is thought to contribute to the literature; will be conducted to examine the effects of video games and mask painting on anxiety and treatment compliance during nebulizer application in children.
- Conditions
- NEBULIZATION, Children
- Being tested
- Control, Video game, Mask painting
- Keywords
- Nebulizer, Child, Anxiety, Treatment Compliance, Nursing
- Medical subject headings
- Anxiety Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlBehavioural
Children will be monitored when fowler is in position during the use of nebulizers. In the Fowler position, the drug will be drained into the nebulizer chamber. Mask and nebulizer connections will be completed. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. Routine nursing care is applied during the use of nebulizer. During the use of a control group nebulizer, routine nebulizer will be used without video game and mask painting. After the receipt of the receipt, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again.
Video gameBehavioural
Children will be monitoring while the fowler position during the use of nebulizers. While the Fowler position is in the position of the drug, the drug will be drained into the nebulizer reservoir. The nebul mask will be attached to cover the mouth and nose. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. At the same time, the Water-Sorting Game will be introduced while the use of nebul will be introduced and you will be asked to play. After the receipt of the receipt, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again.
Mask paintingBehavioural
While the Fowler position is in the position of the drug, the drug will be drained into the nebulizer reservoir. The nebul mask will be attached to cover the mouth and nose. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. At the same time, mask painting process will be introduced while the use of nebul continues. For mask painting, six color paint will be given and the shapes and colors will be completely left to the child by leaving it to him. After the mask painting and receipt is finished, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Behavioral: Control |
| Video game group | Experimental | Not described Receives: Behavioral: Video game |
| Mask painting group | Experimental | Not described Receives: Behavioral: Mask painting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
It was created by the researcher in line with the literature in order to obtain the child's sociodemographic and disease information. The form contains nineteen questions including the child's age, gender, school attendance status, previous nebulizer use status and the reaction if the child has previous nebulizer use experience.
Measured: The introductory information form will be filled out by the researcher during the first nebule treatment of the children's hospitalization. (Approximately 5 minute)
Child Anxiety Scale-State
Child Anxiety Scale-State was developed by Ersıg and his colleagues in 2013 to measure the state anxiety of children between the ages of 4-10, and its validity and reliability in our country were determined by Ozalp Gerceker and his colleagues (2018). The child anxiety scale looks like a thermometer with 10 sections and is very easy to use. It indicates that anxiety increases as you go from bottom to top (0=calm, 10=very anxious). The child is asked to mark the sections on the scale that they feel 'right now'. In the literature research, it was seen that the scale was used between the ages of 7-12.
Measured: After the nebulization process is completed, the child anxiety scale-state scale will be asked to be filled out by the child's parent and the child. (Approximately 10minute). Repeat measurements will be taken 24 hours after the first nebulizer treatment.
Treatment Adherence Questionnaire
The form created by the researchers in line with the literature is a form created to measure children's compliance during treatment. It includes children's reactions and vital signs. This form will be sent to academicians and specialist nurses who are experts in the field of child health and disease nursing and will be presented for expert opinion. The form, which has been finalized and the expert opinion has been completed, will be applied to children during and after the procedure.
Measured: The treatment compliance questionnaire developed by the researchers will be filled out by the researcher. (Approximately 5 minute) Repeat measurements will be taken 24 hours after the first nebulizer treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start9 Dec 2024
- Primary completion15 Mar 2025
- Study completion15 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NEBULIZATIONStudies 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 research is a randomized controlled experimental study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semra Kose
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Semra Kose, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755918
- Sponsor's protocol ID
- NEU2024YLTez(1)
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video Games and Mask Painting on Anxiety and Treatment Compliance During Nebulizer Application in Children: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06755918
- Acronym / sponsor ID
- NEU2024YLTez(1)
- Conditions
- NEBULIZATION, Children
- Keywords
- Nebulizer, Child, Anxiety, Treatment Compliance, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Semra KoseUniversity, hospital or other
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (actual)
- First posted
- 1 Jan 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 clinical features of respiratory system diseases seen in childhood are generally moderate and improve in a short time. Respiratory system diseases are divided into two as upper respiratory system diseases and lower respiratory system diseases. The respiratory tract, from the mouth and nose, which are the upper respiratory tract, to the glottis (nasal mucosa, nasopharynx, oropharynx, sinuses, middle ear tonsils and epiglottis) and the infections that occur in these sections are called upper respiratory tract infections (URTI). Lower respiratory system diseases are considered as tuberculosis, asthma, cystic fibrosis and bronchopulmonary dysplasia. The most common diseases in children are respiratory tract diseases. The diseases that are considered as priorities for each age group vary. According to the Turkish Thoracic Society, the incidence of lower respiratory tract infections (LRTI) between the ages of 0-5 is 29%. According to TUIK 2022 data, upper respiratory tract infections are the most common infectious diseases experienced by children between the ages of 0-6 with a rate of 31.3%, and lower respiratory tract infections are the third with a rate of 6.9%. In children between the ages of 7-14, upper respiratory tract infections are the most common with a rate of 27.1%, and lower respiratory tract infections are the third with a rate of 5.3%.
Detailed description
The treatment of respiratory system diseases includes maintaining airway patency, using antibiotics and corticosteroids, and oxygen support. The most preferred is bronchodilator - vasoconstriction and bronchodilation (nebule therapy). Nebulizer use reduces symptoms by reducing wheezing, shortness of breath, and edema in the respiratory tract, and therapeutics (saline fluids, bronchodilators, epinephrine, anticholinergic agents, and corticosteroids) used are used as a treatment option. The use of nebulizer drugs is used as an emergency treatment method in both children and adults, especially in respiratory system diseases, all over the world and in Turkey. In addition, their use in the treatment of lung diseases is increasing. The main purpose of inhalation treatment is to send smaller amounts of medication directly to the respiratory tract as soon as possible, to deliver drug particles to the farthest lobes of the lungs, to eliminate airway stenosis in the respiratory system and to regulate the amount of mucus.
In children, the process of hospitalization, treatment, and the devices used can be traumatic. Many devices used in the hospital, such as the use of nebulizers, the sounds of the devices, unfamiliar people, unfamiliar environments, dependence on caregivers, unfamiliar tools and equipment, traumatic and painful invasive procedures, separation from family and friends, disruption of routines such as sleep, eating, playing, and school can affect children's anxiety levels and compliance with treatment. The pain and suffering they experience during procedures can be reduced by using distraction methods. One of the distraction methods is therapeutic play. Therapeutic play should be used as an effective method to minimize the negative effects of procedures and to support the child in developing effective coping methods. It has been observed in literature studies that children who use nebulizers together with therapeutic play have decreased fear, pain, anxiety and stress levels. In the study conducted by Kırkan et al. (2023), it was observed that nebulizer treatment with a toy nebulizer and a toy mask decreased children's anxiety levels. In another study conducted by Kurtuncu et al. (2019), it was observed that 3-dimensional nebulizer treatment reduced psychosocial symptoms seen in children. In another study, it was determined that education given with a toy-type nebulizer reduced anxiety levels in children. Therapeutic play allows effective cooperation with the child by understanding the child's behavior. Therapeutic play has an important measure in ensuring that children comply with treatment, display positive behavior, and improve care. This study, which can be easily applied by nurses in the hospital environment before, during, and after medical, invasive procedures, will also ensure children's compliance with treatment and is thought to contribute to the literature; will be conducted to examine the effects of video games and mask painting on anxiety and treatment compliance during nebulizer application in children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The research is a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Control |
| Video game group | Experimental | Behavioral: Video game |
| Mask painting group | Experimental | Behavioral: Mask painting |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between the ages of 7-12
- Receiving the first nebulization treatment after hospitalization
- Able to speak and read Turkish
- Receiving nebulizer treatment
- Children who agree to participate in the study and children whose parents agree to participate in the study
Key exclusion criteria (5 listed)
- Those who are allergic to paint
- Those who have a chronic disease and routinely use a nebulizer
- Those who are connected to any respiratory device (mechanical, etc.)
- Those who did not complete the intervention and wish to withdraw from the study
- Those who have any body function deficiency that prevents coloring or tablet games
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 |
|---|---|---|
| ControlChildren will be monitored when fowler is in position during the use of nebulizers. In the Fowler position, the drug will be drained into the nebulizer chamber. Mask and nebulizer connections will be completed. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. Routine nursing care is applied during the use of nebulizer. During the use of a control group nebulizer, routine nebulizer will be used without video game and mask painting. After the receipt of the receipt, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again. | Behavioural | Control |
| Video gameChildren will be monitoring while the fowler position during the use of nebulizers. While the Fowler position is in the position of the drug, the drug will be drained into the nebulizer reservoir. The nebul mask will be attached to cover the mouth and nose. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. At the same time, the Water-Sorting Game will be introduced while the use of nebul will be introduced and you will be asked to play. After the receipt of the receipt, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again. | Behavioural | Video game group |
| Mask paintingWhile the Fowler position is in the position of the drug, the drug will be drained into the nebulizer reservoir. The nebul mask will be attached to cover the mouth and nose. The patient will be told to breathe slowly and deeply. It will be examined whether sufficient steam is formed from the nebulizer device. The continuation of the application steps will be ensured until the nebulizer drug application is finished. At the same time, mask painting process will be introduced while the use of nebul continues. For mask painting, six color paint will be given and the shapes and colors will be completely left to the child by leaving it to him. After the mask painting and receipt is finished, the child's anxiety scale-status scale will be requested to be filled by the child's parent and child. The treatment questionnaire developed by the researchers will be filled by the researcher. After 24 hours a day after the first nebulizer treatment of hospitalization, measurements will be made again. | Behavioural | Mask painting group |
Primary outcome
Introductory Information Form
Time frame: The introductory information form will be filled out by the researcher during the first nebule treatment of the children's hospitalization. (Approximately 5 minute)
It was created by the researcher in line with the literature in order to obtain the child's sociodemographic and disease information. The form contains nineteen questions including the child's age, gender, school attendance status, previous nebulizer use status and the reaction if the child has previous nebulizer use experience.
Child Anxiety Scale-State
Time frame: After the nebulization process is completed, the child anxiety scale-state scale will be asked to be filled out by the child's parent and the child. (Approximately 10minute). Repeat measurements will be taken 24 hours after the first nebulizer treatment.
Child Anxiety Scale-State was developed by Ersıg and his colleagues in 2013 to measure the state anxiety of children between the ages of 4-10, and its validity and reliability in our country were determined by Ozalp Gerceker and his colleagues (2018). The child anxiety scale looks like a thermometer with 10 sections and is very easy to use. It indicates that anxiety increases as you go from bottom to top (0=calm, 10=very anxious). The child is asked to mark the sections on the scale that they feel 'right now'. In the literature research, it was seen that the scale was used between the ages of 7-12.
Treatment Adherence Questionnaire
Time frame: The treatment compliance questionnaire developed by the researchers will be filled out by the researcher. (Approximately 5 minute) Repeat measurements will be taken 24 hours after the first nebulizer treatment.
The form created by the researchers in line with the literature is a form created to measure children's compliance during treatment. It includes children's reactions and vital signs. This form will be sent to academicians and specialist nurses who are experts in the field of child health and disease nursing and will be presented for expert opinion. The form, which has been finalized and the expert opinion has been completed, will be applied to children during and after the procedure.
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 4 Sep 2026.
- 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 Video game and Mask painting in people with NEBULIZATION and Children, run by Semra Kose 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 5 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 4 Sep 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?
Introductory Information Form (time frame: The introductory information form will be filled out by the researcher during the first nebule treatment of the children's hospitalization. (Approximately 5 minute)). The study lists 3 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 4 Sep 2026.