Trakya University Hospital
Edirne, 22030, Turkey (Türkiye)
NCT Number: NCT07842263
Blood collection can cause pain and anxiety in children. This randomized controlled study investigated whether using a pop-it game or a stress ball during blood collection could reduce pain and anxiety in children aged 3-6 years. The study included 78 children who were assigned to a pop-it game group, a stress ball group, or a control group. Pain and anxiety levels were assessed during the blood collection procedure.
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Notify Me3 year–6 year
All sexes
Interventional
Not applicable
Edirne, 22030, Turkey (Türkiye)
Children were assessed according to the inclusion criteria and randomly assigned to the Pop-it, stress ball, or control groups. Children and parents were informed about the study, and informed consent was obtained.
Pain and anxiety were assessed using the Wong-Baker Faces Pain Rating Scale (WBFPRS) and the Children's Emotional Expression Assessment Scale (CEEAS).
Blood collection was performed by the same experienced nurse using a standardized procedure. The Pop-it group played with a Pop-it toy, while the stress ball group squeezed and released a stress ball with their free hand, starting 1 minute before blood collection and continuing throughout the procedure. The control group received routine phlebotomy without any non-pharmacological intervention.
Procedure duration and crying duration were recorded with stopwatches. Anxiety was assessed by both the researcher and the parent during the procedure. One minute after blood collection, pain and anxiety were reassessed using the WBFPRS and CEEAS.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Children in the Pop-it Game Group played with a pop-it toy during the blood collection procedure
Children in the Stress Ball Group squeezed and released a stress ball during the blood collection procedure
Time frame: Immediately after completion of the blood collection procedure
Child-reported pain experienced during the blood collection procedure was assessed using the Wong-Baker FACES Pain Rating Scale immediately after completion of the blood collection procedure
Time frame: 1 minute after completion of the blood collection procedure
Child-reported post-procedural pain was assessed using the Wong-Baker FACES Pain Rating Scale 1 minute after completion of the blood collection procedure.
Time frame: 1 minute before the blood collection procedure; immediately after the procedure for observations made during the procedure; and 1 minute after the procedure
Children's anxiety was assessed independently by parents and researchers using the Children's Emotional Expression Assessment Scale (CEEAS). The scale consists of 25 items scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher levels of anxiety.
Time frame: Perioperative/Periprocedural
Crying duration was assessed using a stopwatch before, during, and after the blood collection procedure. Crying duration was recorded from the onset of crying until cessation of crying for each assessment period
Time frame: From initiation to completion of the blood collection procedure
The duration of the blood collection procedure was measured using a stopwatch from the beginning of the procedure until completion
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Notify MeTrakya University
Other
The Effect of Pop-it Game and Stress Ball Usage on Pain and Anxiety Levels During Blood Collection in Children Aged 3-6 Years
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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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