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Completed

NCT Number: NCT07827781

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

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Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarsus State Hospital

Mersin, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Popit toy

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.

Other names: Stress ball

Primary outcomes

  1. Anxiety levels

    Time frame: 1 day

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

  2. Fear levels

    Time frame: 1 day

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

  3. 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

Secondary outcomes

  1. 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.

  2. The child's heart rate

    Time frame: 1 day

    Heart rate measured using a pulse oximeter.

  3. The child's respiratory rate

    Time frame: 1 day

    Respiratory rate measured before and after the procedure.

  4. The child's Oxygen Saturation (SpO₂)

    Time frame: 1 day

    Peripheral oxygen saturation measured using a pulse oximeter.

  5. The child's body temperature

    Time frame: 1 day

    Body temperature measured before and after the procedure.

Sponsors and collaborators

Lead sponsor

Izmir Katip Celebi University

Other

Registry information

Official study title

The Effect of the Popit Toy and Stress Ball on Anxiety, Fear, Emotional State, and Satisfaction Levels During Inhaler Medication Administration in Children

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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