Inhalation TherapyNCT07073625
During Inhaler Application, Children Were Given Stress Ball and Storybook Reading Interventions
A study testing Stress Ball and Reading Storybook in people with Inhalation Therapy, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
It aims to examine the effects of stress ball and book reading methods on children's fear and anxiety levels during inhalation. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Inhalation Therapy
- What is being tested?
- Stress Ball and Reading Storybook
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- No audiovisual impairment,
- Being open to communication and
- Must be accompanied by a parent.
Who cannot join
- Having special needs,
- Having an audio-visual impairment,
- Learning difficulties or mental retardation and
- Children whose parents do not agree to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erzurum City Hospital
Erzurum, Center, 25000
Zülbiye DEMİR BARBAK, LECTURER, 05435164229, zulbiye.demir@atauni.edu.tr
About this study
Official title: The Effects of Stress Ball and Storybook Reading During Inhaler Application on Fear and Anxiety in Children
It aims to examine the effects of stress ball and book reading methods on children's fear and anxiety levels during inhalation.
Read the detailed description
Ninety-nine volunteer children aged 5-6 who will receive inhalation therapy will be randomly assigned to three groups: stress ball, storybook reading, and control. Children will be assessed before, during, and after the procedure. Inhalation-related fear will be assessed using the Children's Fear Scale, and anxiety will be assessed using the Children's State Anxiety Scale. Furthermore, children's demographic data will be recorded on the Information Form.
- Conditions
- Inhalation Therapy
- Being tested
- Stress Ball, Reading Storybook
- Keywords
- Inhalation therapy, Fear, Anxiety, Stress Ball, Reading Storybook, Child
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress BallOther
Children arriving at the hospital's emergency department and meeting the study criteria will be randomly assigned to the stress ball group. Before inhalation therapy, the child will begin squeezing the chosen stress ball. This will distract their attention, transforming the frightening hospital environment into a fun one. The questionnaires will be completed by the nurse and family five minutes before, during, and after the inhalation therapy.
Reading StorybookOther
The storybook for the children will be selected by child psychologists. The book will be read to the children by their parents. The storybook reading will begin 15 minutes before the inhalation therapy and will be completed before the treatment begins. The storybook will be read to the children only once.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Children aged 5-6 who come to the emergency room with their parents and will receive inhalers will be given stress ball balls in the stress ball group before and after the procedure and will be told to play with them until the procedure is completed. In the book reading group, parents will be asked to read a book about hospital fear, prepared by researchers. Receives: Other: Stress Ball; Other: Reading Storybook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic Information Form
It is a form consisting of a total of 13 questions including the child's age, gender, diagnosis, duration of treatment, number of treatments (How many times did the child come to the clinic?), the status of receiving information about dental treatment and the person who received the information, the education level and occupation of the mother and father, the place where the family lives and the economic situation. It was prepared by the researchers in line with the literature.
Measured: Baseline
Child anxiety Scale-State
"Child Anxiety Scale-State" scale developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years. In 2017, Gerceker et al. carried out Turkish validity study for the scale. CAS-S (State) is designed as a thermometer. At the bottom is the bulb chamber, and upward are horizontal lines. Each horizontal line represents a score, and the thermometer has 10 points. The bulb chamber at the bottom is 0 points and indicates that there is no anxiety. It is interpreted as the rise of anxiety as it rises upwards. The peak is worth 10 points and refers to the highest anxiety.
Measured: Baseline and up to 4 weeks
Child Fear Scale
This scale was developed by McMurtry et al. in 2011. In 2018, Gerceker et al. carried out a Turkish validity study for the scale. The scale is aimed at children aged 5-10 years. The facial muscle changes in fearful expressions are drawn by a graphic artist based on photos of frightened faces. In this scale, the child is shown a scale containing five facial expressions that are evaluated between 0 and 4 points. While 0 point refers to no fear; 4 points refers to the highest fear.
Measured: Baseline and up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inhalation TherapyStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülbiye demir barbak, Ataturk University
- Investigators
- Zülbiye DEMİR BARBAK, 1, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073625
- Sponsor's protocol ID
- Stress Ball, Reading Storybook
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aminabadi NA, Vafaei A, Erfanparast L, Oskouei SG, Jamali Z. Impact of pictorial story on pain perception, situational anxiety and behavior in children: a cognitive-behavioral schema. J Clin Pediatr Dent. 2011 Winter;36(2):127-32. doi: 10.17796/jcpd.36.2.3163251527508338.
PubMed 22524072
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Stress Ball and Storybook Reading During Inhaler Application on Fear and Anxiety in Children
- ClinicalTrials.gov ID
- NCT07073625
- Acronym / sponsor ID
- Stress Ball, Reading Storybook
- Conditions
- Inhalation Therapy
- Keywords
- Inhalation therapy, Fear, Anxiety, Stress Ball, Reading Storybook, Child
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 18 Jul 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.
It aims to examine the effects of stress ball and book reading methods on children's fear and anxiety levels during inhalation.
Detailed description
Ninety-nine volunteer children aged 5-6 who will receive inhalation therapy will be randomly assigned to three groups: stress ball, storybook reading, and control. Children will be assessed before, during, and after the procedure. Inhalation-related fear will be assessed using the Children's Fear Scale, and anxiety will be assessed using the Children's State Anxiety Scale. Furthermore, children's demographic data will be recorded on the Information Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine clinical care will be applied to the control group. No action will be taken. |
| Experimental Group | Experimental | Other: Stress Ball, Other: Reading StorybookChildren aged 5-6 who come to the emergency room with their parents and will receive inhalers will be given stress ball balls in the stress ball group before and after the procedure and will be told to play with them until the procedure is completed. In the book reading group, parents will be asked to read a book about hospital fear, prepared by researchers. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- No audiovisual impairment,
- Being open to communication and
- Must be accompanied by a parent.
Key exclusion criteria (4 listed)
- Having special needs,
- Having an audio-visual impairment,
- Learning difficulties or mental retardation and
- Children whose parents do not agree 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 |
|---|---|---|
| Stress BallChildren arriving at the hospital's emergency department and meeting the study criteria will be randomly assigned to the stress ball group. Before inhalation therapy, the child will begin squeezing the chosen stress ball. This will distract their attention, transforming the frightening hospital environment into a fun one. The questionnaires will be completed by the nurse and family five minutes before, during, and after the inhalation therapy. | Other | Experimental Group |
| Reading StorybookThe storybook for the children will be selected by child psychologists. The book will be read to the children by their parents. The storybook reading will begin 15 minutes before the inhalation therapy and will be completed before the treatment begins. The storybook will be read to the children only once. | Other | Experimental Group |
Primary outcome
Demographic Information Form
Time frame: Baseline
It is a form consisting of a total of 13 questions including the child's age, gender, diagnosis, duration of treatment, number of treatments (How many times did the child come to the clinic?), the status of receiving information about dental treatment and the person who received the information, the education level and occupation of the mother and father, the place where the family lives and the economic situation. It was prepared by the researchers in line with the literature.
Child anxiety Scale-State
Time frame: Baseline and up to 4 weeks
"Child Anxiety Scale-State" scale developed by Ersig et al. in 2013 measures the state anxiety of children aged 4-10 years. In 2017, Gerceker et al. carried out Turkish validity study for the scale. CAS-S (State) is designed as a thermometer. At the bottom is the bulb chamber, and upward are horizontal lines. Each horizontal line represents a score, and the thermometer has 10 points. The bulb chamber at the bottom is 0 points and indicates that there is no anxiety. It is interpreted as the rise of anxiety as it rises upwards. The peak is worth 10 points and refers to the highest anxiety.
Child Fear Scale
Time frame: Baseline and up to 4 weeks
This scale was developed by McMurtry et al. in 2011. In 2018, Gerceker et al. carried out a Turkish validity study for the scale. The scale is aimed at children aged 5-10 years. The facial muscle changes in fearful expressions are drawn by a graphic artist based on photos of frightened faces. In this scale, the child is shown a scale containing five facial expressions that are evaluated between 0 and 4 points. While 0 point refers to no fear; 4 points refers to the highest fear.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Results publication: PubMed 22524072Aminabadi NA, Vafaei A, Erfanparast L, Oskouei SG, Jamali Z. Impact of pictorial story on pain perception, situational anxiety and behavior in children: a cognitive-behavioral schema. J Clin Pediatr Dent. 2011 Winter;36(2):127-32. doi: 10.17796/jcpd.36.2.3163251527508338.
- Randomized Controlled TrialLink provided by the sponsor.
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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.
Zülbiye DEMİR BARBAK, 1 principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball and Reading Storybook in people with Inhalation Therapy, run by Ataturk 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 18 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zülbiye DEMİR BARBAK, 1 (+905435164229, zulbiye.demir@atauni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic Information Form (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT07073625, which also lists 1 linked publication.
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 18 Jul 2025.