Non-Pharmacological InterventionsNCT07827781
The Effect of Using the Popit Toy and Stress Ball During Inhaler Therapy in Children
A study testing Intervention 1 Popit toy and Intervention 2 Stress ball in people with Non-Pharmacological Interventions and NEBULIZATION, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate whether using a popit toy and a stress ball as distraction methods during inhaled medication administration can reduce anxiety, fear, and negative emotional responses and improve satisfaction in children aged 4-6 years receiving treatment in a pediatric emergency unit. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Non-Pharmacological Interventions, NEBULIZATION
- What is being tested?
- Intervention 1 Popit toy and Intervention 2 Stress ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2025to 10 Jan 2026
- 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
- Children aged 4 to 6 years.
- Presentation to the pediatric emergency unit with a respiratory disease requiring inhaled medication (nebulizer or inhaler therapy).
- Oxygen saturation (SpO₂) of 90% or higher before the procedure.
- No congenital anomalies.
- Not crying before the inhaled medication procedure.
- Parent or legal guardian able to provide written informed consent.
- Child willing to participate in the study.
Who cannot join
- The child being younger than 4 or older than 6 years of age
- Having communication, cognitive, or neurological issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Popit Toy and Stress Ball on Anxiety, Fear, Emotional State, and Satisfaction Levels During Inhaler Medication Administration in Children
The goal of this clinical trial is to evaluate whether using a popit toy and a stress ball as distraction methods during inhaled medication administration can reduce anxiety, fear, and negative emotional responses and improve satisfaction in children aged 4-6 years receiving treatment in a pediatric emergency unit.
The main questions it aims to answer are:
Read more
- Does using a popit toy or a stress ball during inhaled medication administration reduce children's anxiety, fear, and negative emotional responses?
- Does using a popit toy or a stress ball improve children's satisfaction with the procedure?
- Do these distraction methods affect physiological parameters? To determine the effects of these non-pharmacological methods, researchers will compare the Popit toy group, the stress ball group, and the standard control group, which receives no intervention.
Researchers compared a pop-it toy group, a stress ball group, and a control group to determine the effects of these non-pharmacological methods.
Participants:
- Participants were randomly assigned to one of three groups: the pop-it toy group, the stress ball group, or the control group.
- They received inhalation therapy according to the standard treatment protocol.
- Assessments of anxiety, fear, emotional state, and satisfaction were conducted before and/or after the procedure.
- Physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) were measured before and after the administration of the inhalation medication.
- Conditions
- Non-Pharmacological Interventions, NEBULIZATION
- Being tested
- Intervention 1 Popit toy, Intervention 2 Stress ball
- Keywords
- Anxiety, Fear, Satisfaction, Inhaled medication, Emergency
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1 Popit toyBehavioural
Also called Popit toy
Children use a Popit toy as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.
Intervention 2 Stress ballBehavioural
Also called Stress ball
Children use a stress ball as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.
| Study group | Role | What they receive |
|---|---|---|
| Popit toy group | Experimental | Before starting the inhaler administration, the child's attention was diverted by introducing a "Popit" toy. The child was encouraged to play with the Popit for 2 minutes before starting inhaler treatment and to continue playing throughout the procedure. Receives: Behavioral: Intervention 1 Popit toy |
| Stress ball group | Experimental | To divert the child's attention before starting the procedure, a stress ball was introduced to the child who was to receive the inhaler treatment. The child was encouraged to play with the stress ball two minutes before starting inhaler treatment, and this activity was continued throughout the procedure Receives: Behavioral: Intervention 2 Stress ball |
| Control group | No intervention | No distraction methods were used during the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety levels
State anxiety measured using the Children's Anxiety Scale-State (CAS-S). Higher scores indicate higher anxiety levels.
Measured: 1 day
Fear levels
Fear assessed using the Children's Fear Scale (CFS). Higher scores indicate greater fear.
Measured: 1 day
Emotional State levels
Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS). Higher scores indicate more negative emotional responses
Measured: 1 day
Secondary outcomes (5)
Satisfaction levels
Children's satisfaction with the inhaled medication procedure measured using the Children's Satisfaction Scale. Higher scores indicate greater satisfaction.
Measured: 1 day
The child's heart rate
Heart rate measured using a pulse oximeter.
Measured: 1 day
The child's respiratory rate
Respiratory rate measured before and after the procedure.
Measured: 1 day
The child's Oxygen Saturation (SpO₂)
Peripheral oxygen saturation measured using a pulse oximeter.
Measured: 1 day
The child's body temperature
Body temperature measured before and after the procedure.
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 posted18 Sep 2026
- Study start10 Feb 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Non-Pharmacological InterventionsStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Dogan, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827781
- Sponsor's protocol ID
- 2025/07
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical and confidentiality considerations related to the participation of children, individual participant data are not publicly available. Data are available from the corresponding author upon reasonable request.
Publications
Bi Y, Song Z, Zhang J, Chen Y, Wang L. Compliance with outpatient nebulization inhalation therapy in preschool children: implication for nursing care. BMC Nurs. 2026 Mar 2;25(1):325. doi: 10.1186/s12912-026-04493-3.
PubMed 41772554Lizano-Barrantes C, Garin O, Dima AL, Mayoral K, Pont A, Ortiz EM, Caballero-Rabasco MA, Praena-Crespo M, Valdesoiro-Navarrete L, Guerra MT, Bercedo-Sanz A, Hernandez G, Maroni C, de Mir I, Carrasco MA, Ortega M, Servan A, Castillo JA, Tato E, Ferrer M; ARCA Group. Inhaler Technique Questionnaire (InTeQ) in pediatric patients with asthma. World J Pediatr. 2023 Aug;19(8):798-804. doi: 10.1007/s12519-023-00695-w. Epub 2023 Mar 6. No abstract available.
PubMed 36879157Macuncu N, Kostak MA. The effect of storytelling and painting on children's fear level and parental health care satisfaction in children aged 3-6 years administered inhaler medication: Randomized controlled study. J Pediatr Nurs. 2025 Jul-Aug;83:55-62. doi: 10.1016/j.pedn.2025.04.014. Epub 2025 Apr 26.
PubMed 40288053Krishnadasan A, Bhayya DP, Samaddar K, Tejaswini V, Krishna AJ. POP IT away! Evaluating pop-it fidget toys to ease dental anxiety in 5-10 years old. Bharati Vidyapeeth Journal of Dentistry and Allied Sciences 2025;2(4):121-4. https://doi.org/10.4103/BVJD.BVJD_19_25.
Bozkul G, Karakul A, Duzkaya DS, Dilsen S. Effect of short film video and video-based education on fear, pain, and satisfaction of children undergoing day surgery. J Pediatr Nurs. 2024 Mar-Apr;75:49-56. doi: 10.1016/j.pedn.2023.11.029. Epub 2023 Dec 14.
PubMed 38101311Meriç TA, Arslan F. Children's Emotional Manifestation Scale validity-reliability study on preschool children. J Health Sport Sci 2024;7(1):55-71. Turkish. https://doi.org/10.61150/jhss.2024070104.
Gerçeker G, Ayar D, Özdemir Z, Bektaş M. Gaining of Children's State Anxiety and Children's Fear Scale to Turkish language. Dokuz Eylül Üniv Hemşirelik Fak Elektron Derg 2018;11(1):9-13. Turkish.
Sorkun E, Acikgoz A, Sahin S. The Effect of Using Soundproof Nebulizers With Music and a Funny Mask Added to Reduce Children's Anxiety in Medical Procedures: A Randomized Controlled Experimental Study. J Eval Clin Pract. 2025 Aug;31(5):e70244. doi: 10.1111/jep.70244.
PubMed 40838433Altay G, Metin Karaaslan M, Yildiz Y, Demir E. The effect of toy-figure nebulizer along with amigurumi-based therapeutic play, and auditory stimulus reduction during inhalation therapy in children: A randomized controlled trial. J Pediatr Nurs. 2025 Nov-Dec;85:577-585. doi: 10.1016/j.pedn.2025.09.021. Epub 2025 Sep 27.
PubMed 41016223Akoy I, Karakul A, Duzkaya DS. Effect of a toy nebulizer and cartoon distraction on fear and anxiety in children aged 4-10 years receiving inhaled medication. Int Emerg Nurs. 2026 Jun;86:101783. doi: 10.1016/j.ienj.2026.101783. Epub 2026 Mar 11.
PubMed 41818882Bawaeda O, Wanda D, Aprillia Z. Effectiveness of pop-it therapeutic play on children's anxiety during inhalation therapy in children's wards. Pediatr Med Chir. 2023 Mar 28;45(s1). doi: 10.4081/pmc.2023.315.
PubMed 36974915Durak 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Popit Toy and Stress Ball on Anxiety, Fear, Emotional State, and Satisfaction Levels During Inhaler Medication Administration in Children
- ClinicalTrials.gov ID
- NCT07827781
- Acronym / sponsor ID
- 2025/07
- Conditions
- Non-Pharmacological Interventions, NEBULIZATION
- Keywords
- Anxiety, Fear, Satisfaction, Inhaled medication, Emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 18 Sep 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.
The goal of this clinical trial is to evaluate whether using a popit toy and a stress ball as distraction methods during inhaled medication administration can reduce anxiety, fear, and negative emotional responses and improve satisfaction in children aged 4-6 years receiving treatment in a pediatric emergency unit.
The main questions it aims to answer are:
- Does using a popit toy or a stress ball during inhaled medication administration reduce children's anxiety, fear, and negative emotional responses?
- Does using a popit toy or a stress ball improve children's satisfaction with the procedure?
- Do these distraction methods affect physiological parameters? To determine the effects of these non-pharmacological methods, researchers will compare the Popit toy group, the stress ball group, and the standard control group, which receives no intervention.
Researchers compared a pop-it toy group, a stress ball group, and a control group to determine the effects of these non-pharmacological methods.
Participants:
- Participants were randomly assigned to one of three groups: the pop-it toy group, the stress ball group, or the control group.
- They received inhalation therapy according to the standard treatment protocol.
- Assessments of anxiety, fear, emotional state, and satisfaction were conducted before and/or after the procedure.
- Physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature) were measured before and after the administration of the inhalation medication.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Popit toy group | Experimental | Behavioral: Intervention 1 Popit toyBefore starting the inhaler administration, the child's attention was diverted by introducing a "Popit" toy. The child was encouraged to play with the Popit for 2 minutes before starting inhaler treatment and to continue playing throughout the procedure. |
| Stress ball group | Experimental | Behavioral: Intervention 2 Stress ballTo divert the child's attention before starting the procedure, a stress ball was introduced to the child who was to receive the inhaler treatment. The child was encouraged to play with the stress ball two minutes before starting inhaler treatment, and this activity was continued throughout the procedure |
| Control group | No intervention | –No distraction methods were used during the intervention. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 4 to 6 years.
- Presentation to the pediatric emergency unit with a respiratory disease requiring inhaled medication (nebulizer or inhaler therapy).
- Oxygen saturation (SpO₂) of 90% or higher before the procedure.
- No congenital anomalies.
- Not crying before the inhaled medication procedure.
Key exclusion criteria (2 listed)
- The child being younger than 4 or older than 6 years of age
- Having communication, cognitive, or neurological issues
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 |
|---|---|---|
| Intervention 1 Popit toyAlso: Popit toyChildren use a Popit toy as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure. | Behavioural | Popit toy group |
| Intervention 2 Stress ballAlso: Stress ballChildren use a stress ball as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure. | Behavioural | Stress ball group |
Primary outcome
Anxiety levels
Time frame: 1 day
State anxiety measured using the Children's Anxiety Scale-State (CAS-S). Higher scores indicate higher anxiety levels.
Fear levels
Time frame: 1 day
Fear assessed using the Children's Fear Scale (CFS). Higher scores indicate greater fear.
Emotional State levels
Time frame: 1 day
Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS). Higher scores indicate more negative emotional responses
5 secondary outcomes
Satisfaction levels
Time frame: 1 day
The child's heart rate
Time frame: 1 day
The child's respiratory rate
Time frame: 1 day
The child's Oxygen Saturation (SpO₂)
Time frame: 1 day
The child's body temperature
Time frame: 1 day
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 18 Sep 2026.
- Results publication: PubMed 41772554Bi Y, Song Z, Zhang J, Chen Y, Wang L. Compliance with outpatient nebulization inhalation therapy in preschool children: implication for nursing care. BMC Nurs. 2026 Mar 2;25(1):325. doi: 10.1186/s12912-026-04493-3.
- Results publication: PubMed 36879157Lizano-Barrantes C, Garin O, Dima AL, Mayoral K, Pont A, Ortiz EM, Caballero-Rabasco MA, Praena-Crespo M, Valdesoiro-Navarrete L, Guerra MT, Bercedo-Sanz A, Hernandez G, Maroni C, de Mir I, Carrasco MA, Ortega M, Servan A, Castillo JA, Tato E, Ferrer M; ARCA Group. Inhaler Technique Questionnaire (InTeQ) in pediatric patients with asthma. World J Pediatr. 2023 Aug;19(8):798-804. doi: 10.1007/s12519-023-00695-w. Epub 2023 Mar 6. No abstract available.
- Results publication: PubMed 40288053Macuncu N, Kostak MA. The effect of storytelling and painting on children's fear level and parental health care satisfaction in children aged 3-6 years administered inhaler medication: Randomized controlled study. J Pediatr Nurs. 2025 Jul-Aug;83:55-62. doi: 10.1016/j.pedn.2025.04.014. Epub 2025 Apr 26.
- Results publicationKrishnadasan A, Bhayya DP, Samaddar K, Tejaswini V, Krishna AJ. POP IT away! Evaluating pop-it fidget toys to ease dental anxiety in 5-10 years old. Bharati Vidyapeeth Journal of Dentistry and Allied Sciences 2025;2(4):121-4. https://doi.org/10.4103/BVJD.BVJD_19_25.
- Results publication: PubMed 38101311Bozkul G, Karakul A, Duzkaya DS, Dilsen S. Effect of short film video and video-based education on fear, pain, and satisfaction of children undergoing day surgery. J Pediatr Nurs. 2024 Mar-Apr;75:49-56. doi: 10.1016/j.pedn.2023.11.029. Epub 2023 Dec 14.
- Results publicationMeriç TA, Arslan F. Children's Emotional Manifestation Scale validity-reliability study on preschool children. J Health Sport Sci 2024;7(1):55-71. Turkish. https://doi.org/10.61150/jhss.2024070104.
- Results publicationGerçeker G, Ayar D, Özdemir Z, Bektaş M. Gaining of Children's State Anxiety and Children's Fear Scale to Turkish language. Dokuz Eylül Üniv Hemşirelik Fak Elektron Derg 2018;11(1):9-13. Turkish.
- Results publication: PubMed 40838433Sorkun E, Acikgoz A, Sahin S. The Effect of Using Soundproof Nebulizers With Music and a Funny Mask Added to Reduce Children's Anxiety in Medical Procedures: A Randomized Controlled Experimental Study. J Eval Clin Pract. 2025 Aug;31(5):e70244. doi: 10.1111/jep.70244.
- Results publication: PubMed 41016223Altay G, Metin Karaaslan M, Yildiz Y, Demir E. The effect of toy-figure nebulizer along with amigurumi-based therapeutic play, and auditory stimulus reduction during inhalation therapy in children: A randomized controlled trial. J Pediatr Nurs. 2025 Nov-Dec;85:577-585. doi: 10.1016/j.pedn.2025.09.021. Epub 2025 Sep 27.
- Results publication: PubMed 41818882Akoy I, Karakul A, Duzkaya DS. Effect of a toy nebulizer and cartoon distraction on fear and anxiety in children aged 4-10 years receiving inhaled medication. Int Emerg Nurs. 2026 Jun;86:101783. doi: 10.1016/j.ienj.2026.101783. Epub 2026 Mar 11.
- Results publication: PubMed 36974915Bawaeda O, Wanda D, Aprillia Z. Effectiveness of pop-it therapeutic play on children's anxiety during inhalation therapy in children's wards. Pediatr Med Chir. 2023 Mar 28;45(s1). doi: 10.4081/pmc.2023.315.
- Results publication: 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. Due to ethical and confidentiality considerations related to the participation of children, individual participant data are not publicly available. Data are available from the corresponding author upon reasonable request.
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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 Intervention 1 Popit toy and Intervention 2 Stress ball in people with Non-Pharmacological Interventions and NEBULIZATION, run by Izmir Katip Celebi 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 7 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 18 Sep 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?
Anxiety levels (time frame: 1 day). 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 NCT07827781, which also lists 12 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 18 Sep 2026.