PainNCT07842263
Effects of Pop-it Game and Stress Ball Use on Pain and Anxiety During Blood Collection in Children Aged 3-6 Years
A study testing Pop-it Game and Stress Ball in people with Pain and Anxiety, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Blood Collection
- What is being tested?
- Pop-it Game and Stress Ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2025to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- inability to perform the phlebotomy procedure on the first attempt.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya University Hospital
Edirne, Edirne, 22030
About this study
Official 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
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.
- Conditions
- Pain, Anxiety, Blood Collection
- Being tested
- Pop-it Game, Stress Ball
- Keywords
- Pain, Anxiety, pop-it toys, stress balls
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pop-it GameBehavioural
Children in the Pop-it Game Group played with a pop-it toy during the blood collection procedure
Stress BallBehavioural
Children in the Stress Ball Group squeezed and released a stress ball during the blood collection procedure
| Study group | Role | What they receive |
|---|---|---|
| Pop-it Game Group | Experimental | Children in this group played with a pop-it toy during the blood collection procedure Receives: Behavioral: Pop-it Game |
| Stress Ball Group | Experimental | Children in this group squeezed and released a stress ball during the blood collection procedure Receives: Behavioral: Stress Ball |
| Control Group | No intervention | Children in this group underwent the routine blood collection procedure without the use of a pop-it game or stress ball. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after completion of the blood collection procedure
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.
Measured: 1 minute after completion of the blood collection procedure
Secondary outcomes (3)
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.
Measured: 1 minute before the blood collection procedure; immediately after the procedure for observations made during the procedure; and 1 minute after the procedure
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
Measured: Perioperative/Periprocedural
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
Measured: From initiation to completion of the blood collection procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start20 Jun 2025
- Primary completion25 Aug 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bensu KENAR, Trakya University
- Investigators
- Bensu KENAR, MSN, Principal investigator, Trakya University Institute of Health SciencesMelahat Akgün Kostak, PhD, Study director, Faculty of Health Sciences, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842263
- Sponsor's protocol ID
- TUTF-GOBAEK 2024/458
- Other IDs
- 2025/40
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07842263
- Acronym / sponsor ID
- TUTF-GOBAEK 2024/458
- Conditions
- Pain, Anxiety, Blood Collection
- Keywords
- Pain, Anxiety, pop-it toys, stress balls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pop-it Game Group | Experimental | Behavioral: Pop-it GameChildren in this group played with a pop-it toy during the blood collection procedure |
| Stress Ball Group | Experimental | Behavioral: Stress BallChildren in this group squeezed and released a stress ball during the blood collection procedure |
| Control Group | No intervention | –Children in this group underwent the routine blood collection procedure without the use of a pop-it game or stress ball. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (1 listed)
- inability to perform the phlebotomy procedure on the first attempt.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pop-it GameChildren in the Pop-it Game Group played with a pop-it toy during the blood collection procedure | Behavioural | Pop-it Game Group |
| Stress BallChildren in the Stress Ball Group squeezed and released a stress ball during the blood collection procedure | Behavioural | Stress Ball Group |
Primary outcome
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
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.
3 secondary outcomes
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
Crying duration before, during and after the blood collection procedure
Time frame: Perioperative/Periprocedural
Duration of the blood collection procedure
Time frame: From initiation to completion of the blood collection procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bensu KENAR, MSN principal investigator
Trakya University Institute of Health Sciences
Melahat Akgün Kostak, PhD study director
Faculty of Health Sciences, Trakya University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pop-it Game and Stress Ball in people with Pain and Anxiety, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.