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NCT Number: NCT07842263

Effects of Pop-it Game and Stress Ball Use on Pain and Anxiety During Blood Collection in Children Aged 3-6 Years

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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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trakya University Hospital

Edirne, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 3 to 6 years.
  • Accompanied by a parent.
  • Absence of any auditory, mental, or neurological disability
  • Being communicative and open to interaction.
  • Not having received any analgesic, antipyretic, anti-inflammatory, sedative, or anxiolytic medication within the previous 6 hours.
  • Absence of acute pain prior to the procedure.
  • Phlebotomy performed by the same nurse.
  • No history of regular invasive procedures (i.e., no chronic disease requiring routine blood monitoring, such as cancer or diabetes).
  • Willingness of both the child and parent to participate in the study.

Exclusion criteria

  • inability to perform the phlebotomy procedure on the first attempt.

Treatment and study plan

Pop-it Game

Behavioral

Children in the Pop-it Game Group played with a pop-it toy during the blood collection procedure

stress ball

Behavioral

Children in the Stress Ball Group squeezed and released a stress ball during the blood collection procedure

Primary outcomes

  1. Child-reported pain experienced during the blood collection procedure assessed using the Wong-Baker FACES Pain Rating Scale

    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

  2. Child-reported post-procedural pain assessed using the Wong-Baker FACES Pain Rating Scale

    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.

Secondary outcomes

  1. Anxiety assessed using the Children's Emotional Expression Assessment Scale by parents and researchers

    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.

  2. Crying duration before, during and after the blood collection procedure

    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

  3. Duration of the blood collection procedure

    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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

The Effect of Pop-it Game and Stress Ball Usage on Pain and Anxiety Levels During Blood Collection in Children Aged 3-6 Years

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2026
Registry last updated
Sep 25, 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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