Venipuncture-related Pain and AnxietyNCT07513272
EFFECT OF BALLS ON PAIN AND ANXIETY DURING VENIPUNCTURE IN CHILDREN
A study testing Soft ball and spiky ball in people with Venipuncture-related Pain and Anxiety, run by Ankara University.
Trial summary
The goal of this clinical trial is to evaluate whether using two different types of balls can reduce pain and anxiety during venipuncture in school-aged children (7-12 years) in a pediatric emergency setting. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Venipuncture-related Pain and Anxiety
- What is being tested?
- Soft ball and spiky ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7-12 years. At least one prior experience of blood draw within the past year. Able to communicate in Turkish. Written informed consent obtained from both child and parents. No physical, auditory, intellectual, or neurological disabilities. No dermatological conditions affecting hand integrity. No analgesic, antipyretic, or anti-inflammatory drug use within the last 12 hours.
- No acute pain reported before the procedure. No chronic illness causing regular invasive procedures or chronic pain.
Who cannot join
- Inability to complete the first blood draw. Holding another object during the procedure. Withdrawal from the study at any point. Not meeting any of the inclusion criteria listed above.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
aylin arıkan, phd contact
About this study
Official title: THE EFFECT OF TWO DIFFERENT BALLS USED DURING VENIPUNCTURE IN CHILDREN ON PAIN AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY
The goal of this clinical trial is to evaluate whether using two different types of balls can reduce pain and anxiety during venipuncture in school-aged children (7-12 years) in a pediatric emergency setting. The main questions it aims to answer are:
Does squeezing a soft ball or a textured (ridged) ball during venipuncture reduce perceived pain compared to a control group? Does squeezing a soft ball or a textured (ridged) ball during venipuncture reduce situational anxiety compared to a control group?
Read more
Researchers will compare the soft ball, textured ball, and control groups to see if the type of ball affects children's pain and anxiety levels.
Participants will:
Complete a demographic and clinical information form. Use Wong-Baker Faces Pain Rating Scale (WBS) and Child Anxiety Scale-State (ÇAS-D) to report pain and anxiety before, during, and after venipuncture.
Squeeze either a soft or textured ball during venipuncture (for experimental groups) while control group children receive standard care without distraction.
- Conditions
- Venipuncture-related Pain and Anxiety
- Being tested
- Soft ball, spiky ball
- Keywords
- pain, child, venipuncture, anxiety
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft ballOther
Participants will squeeze a soft, non-resistant ball with the hand opposite to the venipuncture site during blood draw to provide distraction and tactile stimulation. The ball is easily compressible, returns to its original shape, and is safe for repeated use.
spiky ballOther
Participants will squeeze a textured (spiky), resistant ball with the hand opposite to the venipuncture site during blood draw to provide tactile stimulation and distraction. The ball has small rounded protrusions, offers resistance when squeezed, and is safe for repeated use.
| Study group | Role | What they receive |
|---|---|---|
| soft ball | Experimental | Participants will squeeze a soft, non-resistant ball with the hand opposite to the venipuncture site during blood draw to provide distraction and tactile stimulation. Receives: Other: Soft ball |
| spiky ball | Experimental | Participants will squeeze a textured (spiky), resistant ball with the hand opposite to the venipuncture site during blood draw to provide tactile stimulation and distraction. Receives: Other: spiky ball |
| Control | No intervention | Participants will undergo standard venipuncture care without the use of any ball or additional distraction intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Level During Venipuncture
Anxiety will be assessed using the Child Anxiety Scale-Situational before, during, and after venipuncture.
Measured: Immediately before, during, and immediately after venipuncture
Pain Level During Venipuncture
Pain will be assessed using the Wong-Baker Faces Pain Rating Scale (WBS) before, during, and after venipuncture.
Measured: Immediately before, during, and immediately after venipuncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venipuncture-related Pain and AnxietyStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeynep Yurdakul, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513272
- Sponsor's protocol ID
- PAIN AND ANXIETY VENIPUNCTURE
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy and confidentiality.
Publications
Hjelmgren H, Ygge BM, Nordlund B, Andersson N. Nurses' experiences of blood sample collection from children: a qualitative study from Swedish paediatric hospital care. BMC Nurs. 2022 Mar 15;21(1):62. doi: 10.1186/s12912-022-00840-2.
PubMed 35292007
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF TWO DIFFERENT BALLS USED DURING VENIPUNCTURE IN CHILDREN ON PAIN AND ANXIETY LEVELS: A RANDOMIZED CONTROLLED STUDY
- ClinicalTrials.gov ID
- NCT07513272
- Acronym / sponsor ID
- PAIN AND ANXIETY VENIPUNCTURE
- Conditions
- Venipuncture-related Pain and Anxiety
- Keywords
- pain, child, venipuncture, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 7 Apr 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.
The goal of this clinical trial is to evaluate whether using two different types of balls can reduce pain and anxiety during venipuncture in school-aged children (7-12 years) in a pediatric emergency setting. The main questions it aims to answer are:
Does squeezing a soft ball or a textured (ridged) ball during venipuncture reduce perceived pain compared to a control group? Does squeezing a soft ball or a textured (ridged) ball during venipuncture reduce situational anxiety compared to a control group?
Researchers will compare the soft ball, textured ball, and control groups to see if the type of ball affects children's pain and anxiety levels.
Participants will:
Complete a demographic and clinical information form. Use Wong-Baker Faces Pain Rating Scale (WBS) and Child Anxiety Scale-State (ÇAS-D) to report pain and anxiety before, during, and after venipuncture.
Squeeze either a soft or textured ball during venipuncture (for experimental groups) while control group children receive standard care without distraction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| soft ball | Experimental | Other: Soft ballParticipants will squeeze a soft, non-resistant ball with the hand opposite to the venipuncture site during blood draw to provide distraction and tactile stimulation. |
| spiky ball | Experimental | Other: spiky ballParticipants will squeeze a textured (spiky), resistant ball with the hand opposite to the venipuncture site during blood draw to provide tactile stimulation and distraction. |
| Control | No intervention | –Participants will undergo standard venipuncture care without the use of any ball or additional distraction intervention. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 7-12 years. At least one prior experience of blood draw within the past year. Able to communicate in Turkish. Written informed consent obtained from both child and parents. No physical, auditory, intellectual, or neurological disabilities. No dermatological conditions affecting hand integrity. No analgesic, antipyretic, or anti-inflammatory drug use within the last 12 hours.
- No acute pain reported before the procedure. No chronic illness causing regular invasive procedures or chronic pain.
Key exclusion criteria (1 listed)
- Inability to complete the first blood draw. Holding another object during the procedure. Withdrawal from the study at any point. Not meeting any of the inclusion criteria listed above.
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 |
|---|---|---|
| Soft ballParticipants will squeeze a soft, non-resistant ball with the hand opposite to the venipuncture site during blood draw to provide distraction and tactile stimulation. The ball is easily compressible, returns to its original shape, and is safe for repeated use. | Other | soft ball |
| spiky ballParticipants will squeeze a textured (spiky), resistant ball with the hand opposite to the venipuncture site during blood draw to provide tactile stimulation and distraction. The ball has small rounded protrusions, offers resistance when squeezed, and is safe for repeated use. | Other | spiky ball |
Primary outcome
Anxiety Level During Venipuncture
Time frame: Immediately before, during, and immediately after venipuncture
Anxiety will be assessed using the Child Anxiety Scale-Situational before, during, and after venipuncture.
Pain Level During Venipuncture
Time frame: Immediately before, during, and immediately after venipuncture
Pain will be assessed using the Wong-Baker Faces Pain Rating Scale (WBS) before, during, and after venipuncture.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 35292007Hjelmgren H, Ygge BM, Nordlund B, Andersson N. Nurses' experiences of blood sample collection from children: a qualitative study from Swedish paediatric hospital care. BMC Nurs. 2022 Mar 15;21(1):62. doi: 10.1186/s12912-022-00840-2.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy and confidentiality.
Related trials for Venipuncture-related Pain and Anxiety
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.
aylin arıkan, phd contact
Questions about this trial
What is this clinical trial studying?
A study testing Soft ball and spiky ball in people with Venipuncture-related Pain and Anxiety, run by Ankara University.
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 2 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: opening soon, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zeynep yurdakul, phd (05545640036, zeyneppyurdakull@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Level During Venipuncture (time frame: Immediately before, during, and immediately after venipuncture). 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?
On the ClinicalTrials.gov record for NCT07513272, which also lists 1 linked publication.
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 7 Apr 2026.