The Effect of Using the Popit Toy and Stress Ball During Inhaler Therapy in Children
14. september 2026 oppdatert av: Pınar Dogan, Izmir Katip Celebi University
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:
- 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
105
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Mersin, Tyrkia (Türkiye)
- Tarsus State Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- The child being younger than 4 or older than 6 years of age
- Having communication, cognitive, or neurological issues
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Popit toy group
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.
|
Children use a Popit toy as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.
Andre navn:
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Eksperimentell: Stress ball group
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
|
Children use a stress ball as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.
Andre navn:
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Ingen inngripen: Control group
No distraction methods were used during the intervention.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Anxiety levels
Tidsramme: 1 day
|
State anxiety measured using the Children's Anxiety Scale-State (CAS-S).
Higher scores indicate higher anxiety levels.
|
1 day
|
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Fear levels
Tidsramme: 1 day
|
Fear assessed using the Children's Fear Scale (CFS).
Higher scores indicate greater fear.
|
1 day
|
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Emotional State levels
Tidsramme: 1 day
|
Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS).
Higher scores indicate more negative emotional responses
|
1 day
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Satisfaction levels
Tidsramme: 1 day
|
Children's satisfaction with the inhaled medication procedure measured using the Children's Satisfaction Scale.
Higher scores indicate greater satisfaction.
|
1 day
|
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The child's heart rate
Tidsramme: 1 day
|
Heart rate measured using a pulse oximeter.
|
1 day
|
|
The child's respiratory rate
Tidsramme: 1 day
|
Respiratory rate measured before and after the procedure.
|
1 day
|
|
The child's Oxygen Saturation (SpO₂)
Tidsramme: 1 day
|
Peripheral oxygen saturation measured using a pulse oximeter.
|
1 day
|
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The child's body temperature
Tidsramme: 1 day
|
Body temperature measured before and after the procedure.
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1 day
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Bawaeda 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.
- Altay 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.
- 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.
- Lizano-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.
- Macuncu 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.
- Krishnadasan 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.
- Meriç 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.
- Akoy 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.
- Durak 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
10. februar 2025
Primær fullføring (Faktiske)
10. januar 2026
Studiet fullført (Faktiske)
10. januar 2026
Datoer for studieregistrering
Først innsendt
8. juli 2026
Først innsendt som oppfylte QC-kriteriene
14. september 2026
Først lagt ut (Faktiske)
18. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025/07
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .