FearNCT06339112
The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety on Children
A study testing Playing with toy nebulizer and Cartoon in people with Fear and Anxiety, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Fear, Anxiety, Inhalant Use
- What is being tested?
- Playing with toy nebulizer and Cartoon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 19 Nov 2024
- 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
- No healthy volunteers
- Child
Who may be able to join
- The child is between 4 and 6 years old,
- No communication problems (visual/auditory/mental),
- Oxygen saturation is 90% or above,
- The child does not have a disease that may affect his/her life,
- Parent and child volunteering to participate in the research.
Who cannot join
- Nebul drug administration
- The child has visual, hearing, and mental disabilities,
- Having taken medication with a nebulizer before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety of 4-6-year-old Children Who Are Administered Inhaler Medication.
This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program, in line with the literature (Durak 2019; Özsamuri 2020). While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data.
Read the detailed description
This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program, in line with the literature. While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data.
Data collection In the study, children treated in pediatric emergency departments and administered inhaler medication will first be evaluated in terms of sampling criteria, and children who do not meet the criteria will be excluded from the study. The nurse researcher is the one who collects the data, evaluates it with the Fear and Anxiety Scale, and evaluates the physiological parameters.
Data analyses The data obtained in the study were analyzed using the Statistical Package for Social Sciences for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean and standard deviation) will be used when evaluating the data. The suitability of the data used to normal distribution will be checked with kurtosis and skewness values. In normally distributed data, when comparing quantitative data, an independent t-test will be used for the difference between two independent groups, and when comparing more than two dependent groups, analysis of variance will be applied in repeated measurements, and in case of a difference, Bonferroni will be used to find the group that makes the difference. In comparing quantitative data with non-normally distributed data, the Mann-Whitney U test will be applied for the difference between two independent groups, and in comparing more than two dependent groups, the Friedman test will be applied, and in case of a difference, the corrected Bonferroni will be used to find the group that makes the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in interobserver agreement analysis.
- Conditions
- Fear, Anxiety, Inhalant Use
- Being tested
- Playing with toy nebulizer, Cartoon
- Keywords
- fear, anxiety, children, emergency
- Medical subject headings
- Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Playing with toy nebulizerOther
The child who needs to take inhaler medication is taken to the observation room. Before starting the procedure, the toy nebulizer is introduced to the child. The toy nebulizer is shown to the child as an example and allowed to play, thus reducing the level of fear. Inhaler medication is given through a mask for 10 minutes. Vital signs (pulse) before and after the application. , blood pressure, SPo2, respiration), the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
CartoonOther
Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. 2-3 minutes before starting drug treatment, the child will be allowed to watch cartoons according to his age group and will be encouraged to do so throughout the procedure.
Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| Playing with toy nebulizer | Experimental | The child who needs to take inhaler medication is taken to the observation room. Before starting the procedure, the child will be introduced to the toy nebulizer. The toy nebulizer is shown to the child as an example and allowed to play with it so that the level of fear can be reduced. Receives: Other: Playing with toy nebulizer |
| Cartoon | Experimental | Approximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. 2-3 minutes before starting drug treatment, the child will be allowed to watch cartoons according to his age group and will be encouraged to do so throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application of the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher. Receives: Other: Cartoon |
| Control | No intervention | Routine care will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fear
Child Fear Scale is used to evaluate the anxiety/fear level of children. The scale uses cartoon faces consisting of five pictures and the anxiety/fear level is evaluated with numbers between "0" and "4". The first picture shows a score of "0", that is, "no anxiety/fear is felt", and the last picture shows a score of "4", that is, "the most severe anxiety/fear". As the score increases, the level of anxiety/fear also increases.
Measured: 1 day
anxiety
Child Anxiety Scale-The State scale resembles a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, asks children, "Imagine that all your anxious or nervous emotions are in the bulb or bottom part of the thermometer," or "If you are a little anxious or nervous, the emotions might move up a little bit on the thermometer." If you're very, very anxious or nervous, emotions can run rampant. "Put a line on the thermometer that shows how anxious or angry you are." To measure state anxiety, the child is asked to indicate what he or she is feeling "right now." The score can vary between 0-10.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jun 2024
- Primary completion19 Nov 2024
- Study completion19 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for FearStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Atiye Karakul, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339112
- Sponsor's protocol ID
- 2024/10
- Status last verified
- Nov 2024
- First submitted
- 24 Mar 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Conk, Z. Başbakkal, Z. Yılmaz, H. Bolışık, B. (2013). Pediatri Hemşireliği, Ankara:Akademisyen Tıp Kitabevi.
Erdinç, E. (2022). Evde Nebülizatör Tedavisi Kime? Nasıl?. ToraksDergisi, 3(2), 21-25. Retrieved from https://turkthoracj.org/content/files/sayilar/93/buyuk/pdf_Toraksder_197.pdf
Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.
PubMed 19230769Zengin M, Yayan EH, Duken ME. The Effects of a Therapeutic Play/Play Therapy Program on the Fear and Anxiety Levels of Hospitalized Children After Liver Transplantation. J Perianesth Nurs. 2021 Feb;36(1):81-85. doi: 10.1016/j.jopan.2020.07.006. Epub 2020 Nov 3.
PubMed 33158746Coskunturk AE, Gozen D. The Effect of Interactive Therapeutic Play Education Program on Anxiety Levels of Children Undergoing Cardiac Surgery and Their Mothers. J Perianesth Nurs. 2018 Dec;33(6):781-789. doi: 10.1016/j.jopan.2017.07.009. Epub 2018 Feb 3.
PubMed 29398304Durak 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 33742204
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Playing With a Toy Nebulizer and Watching Cartoons on the Fear and Anxiety of 4-6-year-old Children Who Are Administered Inhaler Medication.
- ClinicalTrials.gov ID
- NCT06339112
- Acronym / sponsor ID
- 2024/10
- Conditions
- Fear, Anxiety, Inhalant Use
- Keywords
- fear, anxiety, children, emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 1 Apr 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.
This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program, in line with the literature (Durak 2019; Özsamuri 2020). While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data.
Detailed description
This research was planned as a randomized controlled experimental type to determine the effect of playing with a toy nebulizer and watching cartoons on children's fear and physiological parameters in 3-6 year old children who were administered inhaler medication. The population of the study, planned as a randomized controlled experimental study, will consist of 4-6 year old children who apply to Tarsus State Hospital pediatric services and receive inhaler treatment. According to the power analysis performed for the sample size, the power of the sample was calculated with the G*Power 3.1 program, in line with the literature. While the amount of Type I error was 0.05 and the power of the test was 0.95 (α= 0.05, 1-β= 0.95), the minimal sample size was calculated as 105 children (35 children in each group). Considering the possible losses from the sample for any reason during the study period, it was planned to increase the number of samples by 10% and include 38 children in the study and control groups. Child Information Form, Fear Assessment Scale and Child Anxiety Scale-State Scale will be used to collect data.
Data collection In the study, children treated in pediatric emergency departments and administered inhaler medication will first be evaluated in terms of sampling criteria, and children who do not meet the criteria will be excluded from the study. The nurse researcher is the one who collects the data, evaluates it with the Fear and Anxiety Scale, and evaluates the physiological parameters.
Data analyses The data obtained in the study were analyzed using the Statistical Package for Social Sciences for Windows 25.0 program. Descriptive statistical methods (number, percentage, min-max values, mean and standard deviation) will be used when evaluating the data. The suitability of the data used to normal distribution will be checked with kurtosis and skewness values. In normally distributed data, when comparing quantitative data, an independent t-test will be used for the difference between two independent groups, and when comparing more than two dependent groups, analysis of variance will be applied in repeated measurements, and in case of a difference, Bonferroni will be used to find the group that makes the difference. In comparing quantitative data with non-normally distributed data, the Mann-Whitney U test will be applied for the difference between two independent groups, and in comparing more than two dependent groups, the Friedman test will be applied, and in case of a difference, the corrected Bonferroni will be used to find the group that makes the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in interobserver agreement analysis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Playing with toy nebulizer | Experimental | Other: Playing with toy nebulizerThe child who needs to take inhaler medication is taken to the observation room. Before starting the procedure, the child will be introduced to the toy nebulizer. The toy nebulizer is shown to the child as an example and allowed to play with it so that the level of fear can be reduced. |
| Cartoon | Experimental | Other: CartoonApproximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. 2-3 minutes before starting drug treatment, the child will be allowed to watch cartoons according to his age group and will be encouraged to do so throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application of the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher. |
| Control | No intervention | –Routine care will be provided. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child is between 4 and 6 years old,
- No communication problems (visual/auditory/mental),
- Oxygen saturation is 90% or above,
- The child does not have a disease that may affect his/her life,
- Parent and child volunteering to participate in the research.
Key exclusion criteria (3 listed)
- Nebul drug administration
- The child has visual, hearing, and mental disabilities,
- Having taken medication with a nebulizer before
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 |
|---|---|---|
| Playing with toy nebulizerThe child who needs to take inhaler medication is taken to the observation room. Before starting the procedure, the toy nebulizer is introduced to the child. The toy nebulizer is shown to the child as an example and allowed to play, thus reducing the level of fear. Inhaler medication is given through a mask for 10 minutes. Vital signs (pulse) before and after the application. , blood pressure, SPo2, respiration), the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher. | Other | Playing with toy nebulizer |
| CartoonApproximately 10 minutes for the child. Inhaler medication will be given with a mask that lasts. 2-3 minutes before starting drug treatment, the child will be allowed to watch cartoons according to his age group and will be encouraged to do so throughout the procedure. Vital signs (pulse, blood pressure, SPo2, respiration) before and after the application, the Child Fear Scale will be evaluated by the researcher and the parent and recorded in the intervention follow-up form by the researcher. | Other | Cartoon |
Primary outcome
fear
Time frame: 1 day
Child Fear Scale is used to evaluate the anxiety/fear level of children. The scale uses cartoon faces consisting of five pictures and the anxiety/fear level is evaluated with numbers between "0" and "4". The first picture shows a score of "0", that is, "no anxiety/fear is felt", and the last picture shows a score of "4", that is, "the most severe anxiety/fear". As the score increases, the level of anxiety/fear also increases.
anxiety
Time frame: 1 day
Child Anxiety Scale-The State scale resembles a thermometer with a bulb at the bottom and horizontal lines at intervals going upwards. This scale, for children ages 4 to 10, asks children, "Imagine that all your anxious or nervous emotions are in the bulb or bottom part of the thermometer," or "If you are a little anxious or nervous, the emotions might move up a little bit on the thermometer." If you're very, very anxious or nervous, emotions can run rampant. "Put a line on the thermometer that shows how anxious or angry you are." To measure state anxiety, the child is asked to indicate what he or she is feeling "right now." The score can vary between 0-10.
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 20 Nov 2024.
- BackgroundConk, Z. Başbakkal, Z. Yılmaz, H. Bolışık, B. (2013). Pediatri Hemşireliği, Ankara:Akademisyen Tıp Kitabevi.
- BackgroundErdinç, E. (2022). Evde Nebülizatör Tedavisi Kime? Nasıl?. ToraksDergisi, 3(2), 21-25. Retrieved from https://turkthoracj.org/content/files/sayilar/93/buyuk/pdf_Toraksder_197.pdf
- Background: PubMed 19230769Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20.
- Background: PubMed 33158746Zengin M, Yayan EH, Duken ME. The Effects of a Therapeutic Play/Play Therapy Program on the Fear and Anxiety Levels of Hospitalized Children After Liver Transplantation. J Perianesth Nurs. 2021 Feb;36(1):81-85. doi: 10.1016/j.jopan.2020.07.006. Epub 2020 Nov 3.
- Background: PubMed 29398304Coskunturk AE, Gozen D. The Effect of Interactive Therapeutic Play Education Program on Anxiety Levels of Children Undergoing Cardiac Surgery and Their Mothers. J Perianesth Nurs. 2018 Dec;33(6):781-789. doi: 10.1016/j.jopan.2017.07.009. Epub 2018 Feb 3.
- 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.
- 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 Playing with toy nebulizer and Cartoon in people with Fear and Anxiety, run by Tarsus 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 5 inclusion and 3 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 20 Nov 2024. 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?
fear (time frame: 1 day). 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 NCT06339112, which also lists 6 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 20 Nov 2024.