The Effect of Using the Popit Toy and Stress Ball During Inhaler Therapy in Children

NCT07827781 | Completed

• 1 other identifier: 2025/07
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Non-Pharmacological Interventions; NEBULIZATION

Keywords

Anxiety; Fear; Satisfaction; Inhaled medication; Emergency

Outcome Measures

Primary Outcomes (3)

• Anxiety levels

  State anxiety measured using the Children's Anxiety Scale-State (CAS-S). Higher scores indicate higher anxiety levels.

  1 day

• Fear levels

  Fear assessed using the Children's Fear Scale (CFS). Higher scores indicate greater fear.

  1 day

• Emotional State levels

  Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS). Higher scores indicate more negative emotional responses

  1 day

Secondary Outcomes (5)

• Satisfaction levels

  1 day

• The child's heart rate

  1 day

• The child's respiratory rate

  1 day

• The child's Oxygen Saturation (SpO₂)

  1 day

• The child's body temperature

  1 day

Study Arms (3)

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.

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

Behavioral: Intervention 2 Stress ball

Control group

NO INTERVENTION

No distraction methods were used during the intervention.

Interventions

Intervention 1 Popit toy BEHAVIORAL

Children use a Popit toy as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.

Also known as: Popit toy

Popit toy group

Intervention 2 Stress ball BEHAVIORAL

Children use a stress ball as a distraction method beginning approximately 2 minutes before inhaled medication administration and continuing throughout the inhalation procedure.

Also known as: Stress ball

Stress ball group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• The child being younger than 4 or older than 6 years of age
• Having communication, cognitive, or neurological issues

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Location

Related Publications (12)

• 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.

  PMID: 41772554 RESULT

• 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.

  PMID: 36879157 RESULT

• 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.

  PMID: 40288053 RESULT

• 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.

  RESULT

• 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.

  PMID: 38101311 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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.

  PMID: 40838433 RESULT

• 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.

  PMID: 41016223 RESULT

• 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.

  PMID: 41818882 RESULT

• 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.

  PMID: 36974915 RESULT

• 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.

  PMID: 33742204 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction; Emergencies

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: September 18, 2026
• Study Start: February 10, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)