Child, OnlyNCT07442019
Fear, Emotional Behaviors and Parental Care Satisfaction Related to Inhalation Therapy
A study testing Finger Puppet, Video Game and Stress Ball in people with Child, Only and Fear, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
This study aim to determine the effect of finger puppet, video game or stress ball methods on the fear levels, emotional behaviors and parental care satisfaction of children aged 4-6 years due to inhaler treatment. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Fear, Pediatric Nursing
- What is being tested?
- Finger Puppet, Video Game and Stress Ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- the child being between 4-6 years old,
- receiving inhaler treatment via mask,
- not having received inhaler treatment for the last 6 months,
- receiving bronchodilator medications as part of inhaler treatment,
- having no vision or speech problems,
- having no hearing problems,
- the child and parent being able to speak and understand Turkish fluently,
- being willing to participate in the study, and the families agreeing to participate in the research and signing the informed consent form.
Who cannot join
- the child receiving medications other than bronchodilators as part of inhaler treatment,
- the child and parent not being able to speak or understand Turkish fluently, and not being willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Finger Puppet, Video Game and Stress Ball on Fear, Emotional Behaviors and Parental Care Satisfaction Related to Inhalation Therapy in 4-6 Year Old Children
This study aim to determine the effect of finger puppet, video game or stress ball methods on the fear levels, emotional behaviors and parental care satisfaction of children aged 4-6 years due to inhaler treatment.
Read the detailed description
This study was conducted in a randomized, experimental research design. The study was conducted in the pediatric emergency unit of a public hospital with 120 children between January 2024-2025. The finger puppet, stress ball, and video game groups each have 40 children. The inclusion criteria are: the child must be between 4-6 years old, receive inhaler treatment via mask, not have received inhaler treatment for the last 6 months, receive bronchodilator medications as part of inhaler treatment, have no vision or speech problems, have no hearing problems, both the child and the parent must speak and understand Turkish fluently, and the child must be willing to participate in the study, with the families agreeing to participate in the research and signing the informed consent form. Data were collected using the descriptive information form, child fear scale, children's emotional manifestation scale and PedsQL health care satisfaction scale. It was found that finger puppet and video game were more effective on emotional values during inhaler treatment procedure in children compared to stress ball.
- Conditions
- Child, Only, Fear, Pediatric Nursing, Emotions
- Being tested
- Finger Puppet, Video Game, Stress Ball
- Keywords
- Child, Emotions, Pediatric Nursing, Fear
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finger PuppetOther
Finger Puppet
Video GameOther
Video Game
Stress BallOther
Stress Ball
| Study group | Role | What they receive |
|---|---|---|
| Finger Puppet | Experimental | A "Finger Puppet Scenario Text" was prepared for use with children during inhaler treatment. The finger puppets used in the study were designed specifically for this research, being colorful and wearable on the finger for both boys and girls. This scenario text and the puppets were evaluated by experts.
In the finger puppet application, the researcher introduced the finger puppets to the children before inhaler treatment. Then, the finger puppet scenario was implemented by the researcher. This stage lasted approximately 10 minutes. During inhaler treatment, as outlined in the finger puppet scenario text, the puppet remained silent and in a sleep mode (silent play) throughout the treatment, depending on the cooperation between the child and the puppet.
The Child Fear Scale and the Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment. Receives: Other: Finger Puppet |
| Video Game | Experimental | The video game used in the study was selected from among the children's parent's mobile phones and chosen by the child themselves. Ten minutes before the start of inhaler treatment, the video game was introduced and explained, and the child was asked to start playing and continue playing the video game throughout the inhaler treatment. The video game playing time lasted approximately 10 minutes. During inhaler treatment, children in the video game group were allowed to play the video game. The mask remained on the child while playing the video game. The Child Fear Scale and Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment. Receives: Other: Video Game |
| Stress Ball | Experimental | In this study, a stress ball was chosen that was soft and sized appropriately for the child's hand. Children in the stress ball group were given a stress ball before the procedure and asked to squeeze it during the procedure. Ten minutes before the start of inhaler treatment, the child was given the stress ball, introduced to it, and asked to squeeze, release, and play with it. The Child Fear Scale and the Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment. Receives: Other: Stress Ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
child fear scale
The scale can be used to determine the level of fear in children aged 4-10 years. It is administered by showing the child five facial expressions, ranging from a neutral expression ("0") to a frightened face ("4").
Measured: The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.
children's emotional manifestation scale
The scale can evaluate children's emotional indicators based on five parameters. These five parameters are: facial expression, vocal activity, interaction, and level of cooperation.
Measured: The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.
PedsQL health care satisfaction scale
The scale includes six main categories: information, family involvement, communication, technical skills, emotional needs, and overall satisfaction. The scale is evaluated based on the understanding that higher scores indicate higher satisfaction levels.
Measured: Parents were asked to evaluate and record their satisfaction with the PedsQL Healthcare Satisfaction Scale immediately after the inhaler treatment was completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was conducted in a randomized, experimental research design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vildan Apaydın Cırık, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442019
- Sponsor's protocol ID
- KMU-SBF-VAC-01
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Finger Puppet, Video Game and Stress Ball on Fear, Emotional Behaviors and Parental Care Satisfaction Related to Inhalation Therapy in 4-6 Year Old Children
- ClinicalTrials.gov ID
- NCT07442019
- Acronym / sponsor ID
- KMU-SBF-VAC-01
- Conditions
- Child, Only, Fear, Pediatric Nursing, Emotions
- Keywords
- Child, Emotions, Pediatric Nursing, Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 2 Mar 2026 (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 study aim to determine the effect of finger puppet, video game or stress ball methods on the fear levels, emotional behaviors and parental care satisfaction of children aged 4-6 years due to inhaler treatment.
Detailed description
This study was conducted in a randomized, experimental research design. The study was conducted in the pediatric emergency unit of a public hospital with 120 children between January 2024-2025. The finger puppet, stress ball, and video game groups each have 40 children. The inclusion criteria are: the child must be between 4-6 years old, receive inhaler treatment via mask, not have received inhaler treatment for the last 6 months, receive bronchodilator medications as part of inhaler treatment, have no vision or speech problems, have no hearing problems, both the child and the parent must speak and understand Turkish fluently, and the child must be willing to participate in the study, with the families agreeing to participate in the research and signing the informed consent form. Data were collected using the descriptive information form, child fear scale, children's emotional manifestation scale and PedsQL health care satisfaction scale. It was found that finger puppet and video game were more effective on emotional values during inhaler treatment procedure in children compared to stress ball.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This study was conducted in a randomized, experimental research design.
| Arm | Type | Receives |
|---|---|---|
| Finger Puppet | Experimental | Other: Finger PuppetA "Finger Puppet Scenario Text" was prepared for use with children during inhaler treatment. The finger puppets used in the study were designed specifically for this research, being colorful and wearable on the finger for both boys and girls. This scenario text and the puppets were evaluated by experts. In the finger puppet application, the researcher introduced the finger puppets to the children before inhaler treatment. Then, the finger puppet scenario was implemented by the researcher. This stage lasted approximately 10 minutes. During inhaler treatment, as outlined in the finger puppet scenario text, the puppet remained silent and in a sleep mode (silent play) throughout the treatment, depending on the cooperation between the child and the puppet. The Child Fear Scale and the Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment. |
| Video Game | Experimental | Other: Video GameThe video game used in the study was selected from among the children's parent's mobile phones and chosen by the child themselves. Ten minutes before the start of inhaler treatment, the video game was introduced and explained, and the child was asked to start playing and continue playing the video game throughout the inhaler treatment. The video game playing time lasted approximately 10 minutes. During inhaler treatment, children in the video game group were allowed to play the video game. The mask remained on the child while playing the video game. The Child Fear Scale and Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment. |
| Stress Ball | Experimental | Other: Stress BallIn this study, a stress ball was chosen that was soft and sized appropriately for the child's hand. Children in the stress ball group were given a stress ball before the procedure and asked to squeeze it during the procedure. Ten minutes before the start of inhaler treatment, the child was given the stress ball, introduced to it, and asked to squeeze, release, and play with it. The Child Fear Scale and the Emotional Indicators Scale were evaluated and recorded before, during, and after inhaler treatment. The PedsQL Healthcare Satisfaction Scale was evaluated at the end of inhaler treatment. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- the child being between 4-6 years old,
- receiving inhaler treatment via mask,
- not having received inhaler treatment for the last 6 months,
- receiving bronchodilator medications as part of inhaler treatment,
- having no vision or speech problems,
Key exclusion criteria (2 listed)
- the child receiving medications other than bronchodilators as part of inhaler treatment,
- the child and parent not being able to speak or understand Turkish fluently, and not being willing to participate 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 |
|---|---|---|
| Finger PuppetFinger Puppet | Other | Finger Puppet |
| Video GameVideo Game | Other | Video Game |
| Stress BallStress Ball | Other | Stress Ball |
Primary outcome
child fear scale
Time frame: The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.
The scale can be used to determine the level of fear in children aged 4-10 years. It is administered by showing the child five facial expressions, ranging from a neutral expression ("0") to a frightened face ("4").
children's emotional manifestation scale
Time frame: The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.
The scale can evaluate children's emotional indicators based on five parameters. These five parameters are: facial expression, vocal activity, interaction, and level of cooperation.
PedsQL health care satisfaction scale
Time frame: Parents were asked to evaluate and record their satisfaction with the PedsQL Healthcare Satisfaction Scale immediately after the inhaler treatment was completed.
The scale includes six main categories: information, family involvement, communication, technical skills, emotional needs, and overall satisfaction. The scale is evaluated based on the understanding that higher scores indicate higher satisfaction levels.
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 2 Mar 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 Finger Puppet, Video Game and Stress Ball in people with Child, Only and Fear, run by Karamanoğlu Mehmetbey 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 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 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?
child fear scale (time frame: The child was assessed 5 minutes before inhaler treatment. The child was assessed during inhaler treatment. The child was also assessed immediately after inhaler treatment was completed.). 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 2 Mar 2026.