The Effect of Using the Popit Toy and Stress Ball During Inhaler Therapy in Children
14 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
105
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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Mersin, Turquie (Türkiye)
- Tarsus State Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
|
Expérimental: 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.
Autres noms:
|
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Aucune intervention: Control group
No distraction methods were used during the intervention.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety levels
Délai: 1 day
|
State anxiety measured using the Children's Anxiety Scale-State (CAS-S).
Higher scores indicate higher anxiety levels.
|
1 day
|
|
Fear levels
Délai: 1 day
|
Fear assessed using the Children's Fear Scale (CFS).
Higher scores indicate greater fear.
|
1 day
|
|
Emotional State levels
Délai: 1 day
|
Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS).
Higher scores indicate more negative emotional responses
|
1 day
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Satisfaction levels
Délai: 1 day
|
Children's satisfaction with the inhaled medication procedure measured using the Children's Satisfaction Scale.
Higher scores indicate greater satisfaction.
|
1 day
|
|
The child's heart rate
Délai: 1 day
|
Heart rate measured using a pulse oximeter.
|
1 day
|
|
The child's respiratory rate
Délai: 1 day
|
Respiratory rate measured before and after the procedure.
|
1 day
|
|
The child's Oxygen Saturation (SpO₂)
Délai: 1 day
|
Peripheral oxygen saturation measured using a pulse oximeter.
|
1 day
|
|
The child's body temperature
Délai: 1 day
|
Body temperature measured before and after the procedure.
|
1 day
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 février 2025
Achèvement primaire (Réel)
10 janvier 2026
Achèvement de l'étude (Réel)
10 janvier 2026
Dates d'inscription aux études
Première soumission
8 juillet 2026
Première soumission répondant aux critères de contrôle qualité
14 septembre 2026
Première publication (Réel)
18 septembre 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
14 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2025/07
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .