An interventional study of Intervention 1 Popit toy and Intervention 2 Stress ball in Non-Pharmacological Interventions and NEBULIZATION, sponsored by Izmir Katip Celebi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Supportive care
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:
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:
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's enrollment of 105 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 39 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
No distraction methods were used during the intervention.
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
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
Anxiety levels
State anxiety measured using the Children's Anxiety Scale-State (CAS-S). Higher scores indicate higher anxiety levels.
Time frame: 1 day
Fear levels
Fear assessed using the Children's Fear Scale (CFS). Higher scores indicate greater fear.
Time frame: 1 day
Emotional State levels
Emotional responses assessed using the Children's Emotional Manifestation Scale (CEMS). Higher scores indicate more negative emotional responses
Time frame: 1 day
Satisfaction levels
Children's satisfaction with the inhaled medication procedure measured using the Children's Satisfaction Scale. Higher scores indicate greater satisfaction.
Time frame: 1 day
The child's heart rate
Heart rate measured using a pulse oximeter.
Time frame: 1 day
The child's respiratory rate
Respiratory rate measured before and after the procedure.
Time frame: 1 day
The child's Oxygen Saturation (SpO₂)
Peripheral oxygen saturation measured using a pulse oximeter.
Time frame: 1 day
The child's body temperature
Body temperature measured before and after the procedure.
Time frame: 1 day
Plan to share: No — 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.
Ran from Feb 2025 to primary completion in Jan 2026, 11 months.
Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 11 months is close to that.
Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Izmir Katip Celebi University →