- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07827781
The Effect of Using the Popit Toy and Stress Ball During Inhaler Therapy in Children
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Mersin, Turquía (Türkiye)
- Tarsus State Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Children use a Popit toy as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.
Otros nombres:
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Experimental: 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
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Children use a stress ball as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.
Otros nombres:
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Sin intervención: Control group
No distraction methods were used during the intervention.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anxiety levels
Periodo de tiempo: 1 day
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State anxiety measured using the Children's Anxiety Scale-State (CAS-S).
Higher scores indicate higher anxiety levels.
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1 day
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Fear levels
Periodo de tiempo: 1 day
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Fear assessed using the Children's Fear Scale (CFS).
Higher scores indicate greater fear.
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1 day
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Emotional State levels
Periodo de tiempo: 1 day
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Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS).
Higher scores indicate more negative emotional responses
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1 day
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Satisfaction levels
Periodo de tiempo: 1 day
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Children's satisfaction with the inhaled medication procedure measured using the Children's Satisfaction Scale.
Higher scores indicate greater satisfaction.
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1 day
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The child's heart rate
Periodo de tiempo: 1 day
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Heart rate measured using a pulse oximeter.
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1 day
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The child's respiratory rate
Periodo de tiempo: 1 day
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Respiratory rate measured before and after the procedure.
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1 day
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The child's Oxygen Saturation (SpO₂)
Periodo de tiempo: 1 day
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Peripheral oxygen saturation measured using a pulse oximeter.
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1 day
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The child's body temperature
Periodo de tiempo: 1 day
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Body temperature measured before and after the procedure.
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1 day
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/07
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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