PainNCT07654192
The Effect of ShotBlocker and Finger Puppet on Pain and Fear During Blood Drawing in Children
A study testing Distraction techniques in people with Pain and Fear, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
Blood sampling can cause pain, anxiety, and fear in children. Such negative experiences may cause the child to develop negative attitudes toward treatment and care procedures. Distraction techniques, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Fear, Blood Sampling
- What is being tested?
- Distraction techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 10 Jul 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between 5 and 10 years old
- Not having chronic pain
- Not using sedative/anticonvulsant/analgesic medication
- Not having a mental or neurological disability
- Blood collection should be performed by the same nurse
Who cannot join
- Having chronic pain
- Using sedative/anticonvulsant/analgesic medication
- Having a mental or neurological disability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of ShotBlocker and Finger Puppet on Pain and Fear During Blood Drawing in Children: A Randomized Controlled Trial
Blood sampling can cause pain, anxiety, and fear in children. Such negative experiences may cause the child to develop negative attitudes toward treatment and care procedures. Distraction techniques, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. ShotBlocker and finger puppets are one of these techniques. The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sampling in the pediatric blood sampling unit.
- Conditions
- Pain, Fear, Blood Sampling, Children
- Being tested
- Distraction techniques
- Keywords
- pain, fear, blood sampling, children
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction techniquesOther
Distraction techniques such as Shotblocker, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus.
Once the children in the Shotblocker group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins.
Distraction techniquesOther
Distraction techniques such as Finger Puppet, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. Once the children in the Finger Puppet group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins.
| Study group | Role | What they receive |
|---|---|---|
| Shotblocker Group | Active comparator | Shotblocker is administered to children during the blood sampling collection process. Receives: Other: Distraction techniques |
| Finger Puppet Group | Active comparator | Finger Puppet is administered to children during the blood sampling collection process. Receives: Other: Distraction techniques |
| Control Group | No intervention | No intervention is performed on the control group during the blood sampling collection process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sapmling in the pediatric blood collection unit.
On the child fear scale, "0" indicates no fear; "4" indicates the highest level of fear.
It consists of facial expressions ranging from 0, indicating no pain, to 10, representing severe pain.
Data collection takes no more than 10 minutes.
Measured: Time frame is up to 12 moths. From October 01 2025 to October 01 2026.
Secondary outcomes (7)
Randomization
Randomization in the study has been done with using a computer program (https://www.randomizer.org). To determine which children would be in the intervention and control groups, children with numbers from 1 to 90 were entered into the computer program without repetition. To avoid bias in randomisation and to increase reliability, the assignment to the intervention and control groups was made by an independent statistician.
All blood collection procedures will be performed by the same nurse. A nurse with a four-year nursing diploma working in the same blood collection unit will serve as an independent observer. The observer will evaluate the children in the experimental and control groups.
Measured: Time frame is up to 15 minutes.
Data Collection Tools
In data collection, interview and observation form created by researchers (child's age, gender, previous blood sampling experience, etc.), the Children's Fear Scale, and the Wong-Baker FACES Pain Rating Scale will be used for all groups.
Measured: Time frame is up to 15 minutes.
Children's Fear Scale (CFS)
This scale is rating from 0 to 4 with five drawn facial expressions representing a range from a neutral expression (0 = no fear) to a frightened face (4 = extreme fear). It may be used by parents and researchers before and during the procedure for children.
Measured: Time frame is up to 10 minutes.
Wong-Baker FACES (WB-FACES) Pain Rating Scale
This scale is used to rate pain in children aged 3 years and older. The scale consists of facial expressions ranging from 0, indicating no pain, to 10, representing severe pain. Children are asked to select the facial expression that most accurately reflects the intensity of their pain, and then a score is assigned.
Measured: Time frame is up to 10 minutes.
ShotBlocker
ShotBlocker was used on children in the ShotBlocker group during blood sampling. ShotBlocker device (Bionix LLC, Maumee, Ohio, USA) is a drug-free, flexible, and U-shaped, non-invasive plastic apparatus with small protrusions. It is placed directly on the skin and has a slit in the middle for inserting the needle. It is pressed firmly onto the skin, and the blunt contact points provide painless physical stimulation. This blocks the perception of pain caused by needle insertion, which is consistent with the "gate control" theory of pain.
Measured: Time frame is up to 5 minutes.
Finger Puppet
Finger puppets were used on children in the finger puppet group during blood sampling. Finger puppets consist of plush toys featuring various animal figures that can be worn on adults' fingers. The researcher put on the finger puppet chosen by the child and spoke to the child by imitating animal sounds. After the intervention, finger puppets were given as gifts to the children who wanted them.
Measured: Time frame is up to 5 minutes.
Data Collection
The same nurse will perform the blood collection procedure on the children. A nurse with a four-year nursing degree working in the same blood collection unit will become an independent observer. The observer will assess the pain and fears of the children in the experimental and control groups using scales. The researcher will give the interview and observation form to the parent to fill out before the blood drawing. The child's level of fear regarding the procedure will be recorded using the CFS by asking separate questions to the child, parent, and observer before the procedure. The child's fear of the procedure and pain will be separately assessed and recorded by the child, parent, and observer after the procedure. The child, parent, and observer independently and simultaneously evaluated the scales will be used. The ShotBlocker and finger puppet will be administered to the children in the experimental groups by the same researcher.
Measured: Time frame is up to 15 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start1 Oct 2025
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Jul 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 PainStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is being conducted using a parallel group randomized controlled trial design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Ceylan, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654192
- Sponsor's protocol ID
- AIBU-SBF-CC-01
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share individual participant data for data privacy reasons.
Publications
Dinc F, Kurt A, Gunes San E. The effect of three different methods on pain and anxiety in children during blood sampling procedure in pediatric emergency department: Finger puppet, abeslang puzzle, pinwheel. J Pediatr Nurs. 2024 Nov-Dec;79:e203-e212. doi: 10.1016/j.pedn.2024.10.023. Epub 2024 Oct 24.
PubMed 39448323
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of ShotBlocker and Finger Puppet on Pain and Fear During Blood Drawing in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07654192
- Acronym / sponsor ID
- AIBU-SBF-CC-01
- Conditions
- Pain, Fear, Blood Sampling, Children
- Keywords
- pain, fear, blood sampling, children
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 17 Jun 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 sampling can cause pain, anxiety, and fear in children. Such negative experiences may cause the child to develop negative attitudes toward treatment and care procedures. Distraction techniques, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. ShotBlocker and finger puppets are one of these techniques. The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sampling in the pediatric blood sampling unit.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study is being conducted using a parallel group randomized controlled trial design.
| Arm | Type | Receives |
|---|---|---|
| Shotblocker Group | Active comparator | Other: Distraction techniquesShotblocker is administered to children during the blood sampling collection process. |
| Finger Puppet Group | Active comparator | Other: Distraction techniquesFinger Puppet is administered to children during the blood sampling collection process. |
| Control Group | No intervention | –No intervention is performed on the control group during the blood sampling collection process. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being between 5 and 10 years old
- Not having chronic pain
- Not using sedative/anticonvulsant/analgesic medication
- Not having a mental or neurological disability
- Blood collection should be performed by the same nurse
Key exclusion criteria (3 listed)
- Having chronic pain
- Using sedative/anticonvulsant/analgesic medication
- Having a mental or neurological disability
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 |
|---|---|---|
| Distraction techniquesDistraction techniques such as Shotblocker, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. Once the children in the Shotblocker group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins. | Other | Shotblocker Group |
| Distraction techniquesDistraction techniques such as Finger Puppet, which are among non-pharmacological methods, are used to reduce pain, fear, and anxiety by diverting attention away from pain and directing it toward another interesting stimulus. Once the children in the Finger Puppet group sit down in the blood draw chair, the specified procedure will be applied before the blood drawing begins. | Other | Finger Puppet Group |
Primary outcome
Primary Outcome Measure
Time frame: Time frame is up to 12 moths. From October 01 2025 to October 01 2026.
The aim of this study is to evaluate the effectiveness of ShotBlocker and finger puppets in reducing pain and fear in children aged 5-10 years during blood sapmling in the pediatric blood collection unit. On the child fear scale, "0" indicates no fear; "4" indicates the highest level of fear. It consists of facial expressions ranging from 0, indicating no pain, to 10, representing severe pain. Data collection takes no more than 10 minutes.
7 secondary outcomes
Randomization
Time frame: Time frame is up to 15 minutes.
Data Collection Tools
Time frame: Time frame is up to 15 minutes.
Children's Fear Scale (CFS)
Time frame: Time frame is up to 10 minutes.
Wong-Baker FACES (WB-FACES) Pain Rating Scale
Time frame: Time frame is up to 10 minutes.
ShotBlocker
Time frame: Time frame is up to 5 minutes.
Finger Puppet
Time frame: Time frame is up to 5 minutes.
Data Collection
Time frame: Time frame is up to 15 minutes.
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 17 Jun 2026.
- Background: PubMed 39448323Dinc F, Kurt A, Gunes San E. The effect of three different methods on pain and anxiety in children during blood sampling procedure in pediatric emergency department: Finger puppet, abeslang puzzle, pinwheel. J Pediatr Nurs. 2024 Nov-Dec;79:e203-e212. doi: 10.1016/j.pedn.2024.10.023. Epub 2024 Oct 24.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. The investigators will not share individual participant data for data privacy reasons.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction techniques in people with Pain and Fear, run by Abant Izzet Baysal 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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 17 Jun 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?
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?
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?
Primary Outcome Measure (time frame: Time frame is up to 12 moths. From October 01 2025 to October 01 2026.). 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 NCT07654192, 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 17 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.