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

September 14, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Intervention 1 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.
Other Names:
  • Popit toy
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
Behavioral: Intervention 2 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.
Other Names:
  • Stress ball
No Intervention: Control group
No distraction methods were used during the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety levels
Time Frame: 1 day
State anxiety measured using the Children's Anxiety Scale-State (CAS-S). Higher scores indicate higher anxiety levels.
1 day
Fear levels
Time Frame: 1 day
Fear assessed using the Children's Fear Scale (CFS). Higher scores indicate greater fear.
1 day
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction levels
Time Frame: 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
Time Frame: 1 day
Heart rate measured using a pulse oximeter.
1 day
The child's respiratory rate
Time Frame: 1 day
Respiratory rate measured before and after the procedure.
1 day
The child's Oxygen Saturation (SpO₂)
Time Frame: 1 day
Peripheral oxygen saturation measured using a pulse oximeter.
1 day
The child's body temperature
Time Frame: 1 day
Body temperature measured before and after the procedure.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Katip Celebi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2025

Primary Completion (Actual)

January 10, 2026

Study Completion (Actual)

January 10, 2026

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

September 14, 2026

First Posted (Actual)

September 18, 2026

Study Record Updates

Last Update Posted (Actual)

September 18, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe