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CompletedNCT07842263Updated Sep 25, 2026

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

An interventional study of Pop-it Game and Stress Ball in Pain, Anxiety and Blood Collection, sponsored by Trakya University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Trakya University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Pain
  • Anxiety
  • Blood Collection

Keywords

  • Pain
  • Anxiety
  • pop-it toys
  • stress balls
03

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • inability to perform the phlebotomy procedure on the first attempt.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
81 participants (actual)

Study arms

  • Experimental
    Pop-it Game Group

    Children in this group played with a pop-it toy during the blood collection procedure

    Behavioral: Pop-it Game

  • Experimental
    Stress Ball Group

    Children in this group squeezed and released a stress ball during the blood collection procedure

    Behavioral: Stress Ball

  • No intervention
    Control Group

    Children in this group underwent the routine blood collection procedure without the use of a pop-it game or stress ball.

Interventions

  • BehavioralPop-it Game

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

  • BehavioralStress Ball

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

05

What researchers measure

Primary outcomes

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

    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: Immediately after completion of the blood collection procedure

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

    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 after completion of the blood collection procedure

Secondary outcomes

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

    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: 1 minute before the blood collection procedure; immediately after the procedure for observations made during the procedure; and 1 minute after the procedure

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

    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: Perioperative/Periprocedural

  3. Duration 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

    Time frame: From initiation to completion of the blood collection procedure

06

Study locations

1 site
  • Trakya University Hospital
    Edirne, Edirne 22030, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07842263
Lead sponsor
Trakya University
Responsible party
Bensu KENAR (Principal Investigator, Trakya University) — Principal investigator
First posted
Sep 25, 2026
Start date
Jun 20, 2025
Primary completion
Aug 25, 2025
Completion
Aug 25, 2025
Last update
Sep 25, 2026

Study contacts

Bensu KENAR, MSN
principal investigator · Trakya University Institute of Health Sciences
Melahat Akgün Kostak, PhD
study director · Faculty of Health Sciences, Trakya University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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