Children, OnlyNCT05213013
The Effect of Toy-Type Nebulizer on Fear and Anxiety in Children Receiving Inhaler Treatment
A study testing inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/mask in people with Children, Only and Fear Anxiety, run by Aylin Kurt at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of toy-type nebulizers on fear and anxiety in children receiving inhaler therapy. The research hypotheses are as follows: H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Child Fear Scale" and… Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Only, Fear Anxiety, Hospitalism in Children
- What is being tested?
- inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2022to 30 Jan 2023
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child is between the ages of 4-10
- The child's application to the Pediatric Emergency Unit
- Child receiving inhaler treatment for the first time
- Parent and child agreeing to participate in the project
- Absence of speech and visual impairment of the child and his parents
Who cannot join
- The child is not between the ages of 4-10
- The child's application to another department except for the Pediatric Emergency Unit
- Child not receiving inhaler treatment for the first time
- Parent and child not agreeing to participate in the project
- Having speech and visual impairment of the child and his parents
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartın University
Bartın, 74100
Aylin Kurt, +905382087211, aylinkurt67@gmail.com
About this study
The aim of this study is to determine the effect of toy-type nebulizers on fear and anxiety in children receiving inhaler therapy.
The research hypotheses are as follows:
H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Child Fear Scale" and "Child Anxiety Scale-State" during and after the inhaler treatment with a toy-type nebulizer. H1: During and after the s inhaler treatment with the toy-type nebulizer, the mean score of the "Child Fear Scale" and "Child Anxiety Scale-State" is significantly higher in the intervention group compared to the control group.
Read the detailed description
In this study, there will be two groups as the intervention (who will receive inhaler treatment with an education and toy type nebulizer) and the control group (who will not receive training and will receive inhaler treatment with a classic-looking nebulizer). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 32 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital.
Inhaler treatment will be applied to both the intervention and control groups. Both the parent and the child in the intervention group will be trained on the use of a nebulizer/mask. The children in the intervention group will be treated with a toy-type nebulizer and the group will be treated with an inhaler, and the control group will be given inhaler treatment with the standard nebulizer in the hospital. Two researchers were employed for the inhaler treatment both for the intervention and control groups. One researcher performed the inhaler treatment for all children and the other researcher helped the children to assess their fear and anxiety level. Fear and anxiety in children were evaluated by the children and their parents who before, during, and the procedure, and five minutes after the procedure. The inhaler treatment procedure was performed by the same researcher both in the intervention and control groups.
- Conditions
- Children, Only, Fear Anxiety, Hospitalism in Children
- Being tested
- inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/maskOther
The children (experimental group), will receive training and inhaler treatment with the toy-type nebulizer. The training topics is as follows:
- For effective nebulization, it should be ensured that the parts of the mask are assembled completely and correctly.
- The child should be in an upright sitting position during nebulization.
- During the procedure, normal breathing should be given into the mask.
- As the medicine is finished, a sizzling sound is heard from the device.
- After the nebula is over, the face should be washed and the mouth should be rinsed to remove the drug residues accumulated on the face and mouth.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All registered participants in the control group, will receive inhaler treatment with the toy-type nebulizer in the hospital. Both the parent and the child in the intervention group will be trained on the use of a nebulizer/mask. Receives: Other: inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/mask |
| No intervention | No intervention | No intervention. All registered participants in the control group, will receive inhaler treatment with the standard nebulizer in the hospital. Both the parent and the child in the intervention group will not be trained on the use of a nebulizer/mask. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the mean score of the "Child Fear Scale" between intervention and control groups
"The Child Fear Scale" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will fear about the inhaler treatment with a nebulizer in children. This scale will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's fear level before, during and after the proposed intervention. The scale will be made without training and inhaler treatment with a standard nebulizer in the control group. At the end of the study, difference between the mean score of "The Child Fear Scale" between intervention and control groups will be examined. The Child Fear Scale total score mean of the children in the intervention group will be higher after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Difference between the mean score of "The Child Anxiety Meter-State" between intervention and control groups
"The Child Anxiety Meter-State" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will anxiety about the inhaler treatment with a nebulizer in children. This scale will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety level before, during and after the proposed intervention. The scale will be made without training and inhaler treatment with a standard nebulizer in the control group. At the end of the study, difference between the mean score of "The Child Anxiety Meter-State" between intervention and control groups will be examined. The Child Anxiety Meter-State total score mean of the children in the intervention group will be higher after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Secondary outcomes (2)
Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.
"The Child Fear Scale" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will address fear about the inhaler treatment with a nebulizer in children. These surveys will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's fear before, during and after the proposed intervention. The Child Fear Scale total score mean of the children in the intervention group will be higher after the intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Change of the mean scores obtained by the children in the intervention group from the "Child Anxiety Meter-State" before and after the intervention.
"The Child Anxiety Meter-State" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will address anxiety about the inhaler treatment with a nebulizer in children. These surveys will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety before, during and after the proposed intervention. The Child Anxiety Meter-State total score mean of the children in the intervention group will be higher after the intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start30 Jan 2022
- Primary completion28 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children, OnlyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Children and their parents
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aylin Kurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aylin Kurt, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213013
- Sponsor's protocol ID
- 2021-SBB-0333
- Status last verified
- Feb 2023
- First submitted
- 4 Dec 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Toy-Type Nebulizer on Fear and Anxiety in Children Receiving Inhaler Treatment
- ClinicalTrials.gov ID
- NCT05213013
- Acronym / sponsor ID
- 2021-SBB-0333
- Conditions
- Children, Only, Fear Anxiety, Hospitalism in Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Aylin KurtUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 28 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 28 Jan 2022 (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 this study is to determine the effect of toy-type nebulizers on fear and anxiety in children receiving inhaler therapy.
The research hypotheses are as follows:
H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Child Fear Scale" and "Child Anxiety Scale-State" during and after the inhaler treatment with a toy-type nebulizer. H1: During and after the s inhaler treatment with the toy-type nebulizer, the mean score of the "Child Fear Scale" and "Child Anxiety Scale-State" is significantly higher in the intervention group compared to the control group.
Detailed description
In this study, there will be two groups as the intervention (who will receive inhaler treatment with an education and toy type nebulizer) and the control group (who will not receive training and will receive inhaler treatment with a classic-looking nebulizer). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 32 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital.
Inhaler treatment will be applied to both the intervention and control groups. Both the parent and the child in the intervention group will be trained on the use of a nebulizer/mask. The children in the intervention group will be treated with a toy-type nebulizer and the group will be treated with an inhaler, and the control group will be given inhaler treatment with the standard nebulizer in the hospital. Two researchers were employed for the inhaler treatment both for the intervention and control groups. One researcher performed the inhaler treatment for all children and the other researcher helped the children to assess their fear and anxiety level. Fear and anxiety in children were evaluated by the children and their parents who before, during, and the procedure, and five minutes after the procedure. The inhaler treatment procedure was performed by the same researcher both in the intervention and control groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Children and their parents
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/maskAll registered participants in the control group, will receive inhaler treatment with the toy-type nebulizer in the hospital. Both the parent and the child in the intervention group will be trained on the use of a nebulizer/mask. |
| No intervention | No intervention | –No intervention. All registered participants in the control group, will receive inhaler treatment with the standard nebulizer in the hospital. Both the parent and the child in the intervention group will not be trained on the use of a nebulizer/mask. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child is between the ages of 4-10
- The child's application to the Pediatric Emergency Unit
- Child receiving inhaler treatment for the first time
- Parent and child agreeing to participate in the project
- Absence of speech and visual impairment of the child and his parents
Key exclusion criteria (5 listed)
- The child is not between the ages of 4-10
- The child's application to another department except for the Pediatric Emergency Unit
- Child not receiving inhaler treatment for the first time
- Parent and child not agreeing to participate in the project
- Having speech and visual impairment of the child and his parents
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 |
|---|---|---|
| inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/maskThe children (experimental group), will receive training and inhaler treatment with the toy-type nebulizer. The training topics is as follows: * For effective nebulization, it should be ensured that the parts of the mask are assembled completely and correctly. * The child should be in an upright sitting position during nebulization. * During the procedure, normal breathing should be given into the mask. * As the medicine is finished, a sizzling sound is heard from the device. * After the nebula is over, the face should be washed and the mouth should be rinsed to remove the drug residues accumulated on the face and mouth. | Other | Experimental |
Primary outcome
Difference between the mean score of the "Child Fear Scale" between intervention and control groups
Time frame: 12 months
"The Child Fear Scale" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will fear about the inhaler treatment with a nebulizer in children. This scale will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's fear level before, during and after the proposed intervention. The scale will be made without training and inhaler treatment with a standard nebulizer in the control group. At the end of the study, difference between the mean score of "The Child Fear Scale" between intervention and control groups will be examined. The Child Fear Scale total score mean of the children in the intervention group will be higher after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.
Difference between the mean score of "The Child Anxiety Meter-State" between intervention and control groups
Time frame: 12 months
"The Child Anxiety Meter-State" will be completed before training and inhaler treatment with toy-type treatment that gathers quantitative data that will anxiety about the inhaler treatment with a nebulizer in children. This scale will also be completed at the intervention during and ten minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety level before, during and after the proposed intervention. The scale will be made without training and inhaler treatment with a standard nebulizer in the control group. At the end of the study, difference between the mean score of "The Child Anxiety Meter-State" between intervention and control groups will be examined. The Child Anxiety Meter-State total score mean of the children in the intervention group will be higher after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.
2 secondary outcomes
Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.
Time frame: 12 months
Change of the mean scores obtained by the children in the intervention group from the "Child Anxiety Meter-State" before and after the intervention.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inhaler treatment with the toy-type nebulizer and training on on the use of a nebulizer/mask in people with Children, Only and Fear Anxiety, run by Aylin Kurt 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: status not confirmed, as of the sponsor's last update on 8 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the mean score of the "Child Fear Scale" between intervention and control groups (time frame: 12 months). 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 8 Feb 2023.