Distraction MethodsNCT07029633
Effect of Cartoon and Storytelling on the Children's Fear and Anxiety Levels During Inhalation Therapy With Nebulizer in Emergency Department
A study testing storytelling and cartoon in people with Distraction Methods and Child, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Inhalation therapy with a nebulizer is a non-invasive and easy-to-use technology. However, the use of masks and the loud, unpleasant sound of the nebulizer can cause fear and anxiety in children. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Distraction Methods, Child
- What is being tested?
- storytelling and cartoon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2023to 30 Oct 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 5 and 8 years old, who received inhalation therapy with a nebulizer for the first time, had no communication problems, and gave consent were included in the study.
Who cannot join
- Children who had vision, hearing, and comprehension problems, mental and neurological diseases, life-threatening diseases, those who used any medication with sedative effects, or those who refused interventions during nebule treatment were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Inhalation therapy with a nebulizer is a non-invasive and easy-to-use technology. However, the use of masks and the loud, unpleasant sound of the nebulizer can cause fear and anxiety in children. For nebulizer inhalation therapy to be effective, it is important to reduce children's fear and anxiety and to increase their compliance with treatment. Simple and inexpensive distraction methods can be used to achieve this. The results show that cartoon and storytelling methods reduce fear and anxiety in children undergoing inhalation therapy with the nebulizer.
Read the detailed description
This study aimed to evaluate the impact of cartoons and storytelling during nebulizer inhalation treatment on procedure-related fear and anxiety in children. This randomized controlled study employed a 3-arm parallel design with 99 children aged 5-8 receiving nebulizer therapy in the pediatric emergency department. Groups 1 and 2 served as the experimental groups, while Group 3 acted as the control group, with no intervention addressing fear and anxiety. Group 1 utilized storytelling as a distraction, while Group 2 watched cartoons. Data were collected using the Descriptive Characteristics Form, the Child Follow-Up Form, the Children's Anxiety Meter-State, and the Child Fear Scale.
In the study, parental presence was ensured during the procedure in all groups. For this reason, parents were informed, and their questions about inhalation treatment with nebulizers were answered before data collection to reduce parents' stress and anxiety in all groups and to prevent children from being affected by their parents' emotional situation. The parents were seated in a comfortable chair beside the children's bed.
Before the inhalation treatment with a nebulizer, the procedure was explained to the child according to the child's developmental level, the fear and anxiety levels of the children were evaluated, and their cardiorespiratory rates were measured. Then, inhalation therapy with a nebulizer was started. During the procedure, children's anxiety levels, crying situations, and cardiorespiratory rates were measured. After the procedure, the nebulizer was turned off, the mask was removed, and their faces were cleaned. The children's fear and anxiety levels were evaluated for the last time, and their cardiorespiratory rates were measured. The duration of the inhalation treatment was approximately 15 minutes.
- Conditions
- Distraction Methods, Child
- Being tested
- storytelling, cartoon
- Keywords
- anxiety, child, fear, cartoon, storytelling
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
storytellingOther
to distract telling a story
cartoonOther
to distract watching a cartoon
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | To reduce fear and anxiety in the children in this group, the storytelling method was used by the parents during the nebulizer treatments. Receives: Other: storytelling |
| Group 2 | Experimental | During nebulizer treatments, children in this group collaboratively chose cartoons on YouTube with their parents and watched them on phones using the hospital's internet. Receives: Other: cartoon |
| Group 3 | No intervention | No intervention was performed on the children in the control group to reduce fear and anxiety related to inhalation therapy with a nebulizer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
fear level
The Child Fear Scale (CFS) was used children's fear level
Measured: 15-30 minute
anxiety level
To determite anxiety level of children The Children's Anxiety Meter-State (CAM-S) was used.
Measured: 15-30 minute
crying duration
The crying duration of the children during the procedure was measured and recorded by the researchers with a stopwatch.
Measured: 15-30 minute
Cardiorespiratory rates:
Children's respiration rate was measured by observation, pulse rate and SPO2 levels were measured by finger pulse oximeter.
Measured: 15-30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start2 Jan 2023
- Primary completion15 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distraction MethodsStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Serap Ceylan, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029633
- Sponsor's protocol ID
- PamU
- Status last verified
- Jun 2025
- First submitted
- 11 Jun 2025
- Last updated
- 19 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cartoon and Storytelling on the Children's Fear and Anxiety Levels During Inhalation Therapy With Nebulizer in Emergency Department
- ClinicalTrials.gov ID
- NCT07029633
- Acronym / sponsor ID
- PamU
- Conditions
- Distraction Methods, Child
- Keywords
- anxiety, child, fear, cartoon, storytelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 19 Jun 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.
Inhalation therapy with a nebulizer is a non-invasive and easy-to-use technology. However, the use of masks and the loud, unpleasant sound of the nebulizer can cause fear and anxiety in children. For nebulizer inhalation therapy to be effective, it is important to reduce children's fear and anxiety and to increase their compliance with treatment. Simple and inexpensive distraction methods can be used to achieve this. The results show that cartoon and storytelling methods reduce fear and anxiety in children undergoing inhalation therapy with the nebulizer.
Detailed description
This study aimed to evaluate the impact of cartoons and storytelling during nebulizer inhalation treatment on procedure-related fear and anxiety in children. This randomized controlled study employed a 3-arm parallel design with 99 children aged 5-8 receiving nebulizer therapy in the pediatric emergency department. Groups 1 and 2 served as the experimental groups, while Group 3 acted as the control group, with no intervention addressing fear and anxiety. Group 1 utilized storytelling as a distraction, while Group 2 watched cartoons. Data were collected using the Descriptive Characteristics Form, the Child Follow-Up Form, the Children's Anxiety Meter-State, and the Child Fear Scale.
In the study, parental presence was ensured during the procedure in all groups. For this reason, parents were informed, and their questions about inhalation treatment with nebulizers were answered before data collection to reduce parents' stress and anxiety in all groups and to prevent children from being affected by their parents' emotional situation. The parents were seated in a comfortable chair beside the children's bed.
Before the inhalation treatment with a nebulizer, the procedure was explained to the child according to the child's developmental level, the fear and anxiety levels of the children were evaluated, and their cardiorespiratory rates were measured. Then, inhalation therapy with a nebulizer was started. During the procedure, children's anxiety levels, crying situations, and cardiorespiratory rates were measured. After the procedure, the nebulizer was turned off, the mask was removed, and their faces were cleaned. The children's fear and anxiety levels were evaluated for the last time, and their cardiorespiratory rates were measured. The duration of the inhalation treatment was approximately 15 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: storytellingTo reduce fear and anxiety in the children in this group, the storytelling method was used by the parents during the nebulizer treatments. |
| Group 2 | Experimental | Other: cartoonDuring nebulizer treatments, children in this group collaboratively chose cartoons on YouTube with their parents and watched them on phones using the hospital's internet. |
| Group 3 | No intervention | –No intervention was performed on the children in the control group to reduce fear and anxiety related to inhalation therapy with a nebulizer. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 5 and 8 years old, who received inhalation therapy with a nebulizer for the first time, had no communication problems, and gave consent were included in the study.
Key exclusion criteria (1 listed)
- Children who had vision, hearing, and comprehension problems, mental and neurological diseases, life-threatening diseases, those who used any medication with sedative effects, or those who refused interventions during nebule treatment were not included in the study.
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 |
|---|---|---|
| storytellingto distract telling a story | Other | Group 1 |
| cartoonto distract watching a cartoon | Other | Group 2 |
Primary outcome
fear level
Time frame: 15-30 minute
The Child Fear Scale (CFS) was used children's fear level
anxiety level
Time frame: 15-30 minute
To determite anxiety level of children The Children's Anxiety Meter-State (CAM-S) was used.
crying duration
Time frame: 15-30 minute
The crying duration of the children during the procedure was measured and recorded by the researchers with a stopwatch.
Cardiorespiratory rates:
Time frame: 15-30 minute
Children's respiration rate was measured by observation, pulse rate and SPO2 levels were measured by finger pulse oximeter.
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 19 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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 storytelling and cartoon in people with Distraction Methods and Child, run by Pamukkale 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 1 inclusion and 1 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 19 Jun 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?
fear level (time frame: 15-30 minute). The study lists 4 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 19 Jun 2025.