Procedural PainNCT07689370
Buzzy® and Cognitive Behavioral Intervention Package During Blood Draw in Children
A study testing Cognitive Behavioral Intervention Package and Buzzy® in people with Procedural Pain and Procedural Fear, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effects of Buzzy® and a Cognitive Behavioral Intervention Package on pain and fear/anxiety during blood draw in children aged 7-12 years. Blood draw is a common procedure in children, but it may cause pain, fear, and anxiety. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Procedural Pain, Procedural Fear, Procedural Anxiety
- What is being tested?
- Cognitive Behavioral Intervention Package and Buzzy®
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 24 Apr 2026
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7 to 12 years
- Able to read and write
- No chronic disease
- No visual, hearing, verbal communication, cognitive, or neurological impairment
- No use of sedative, analgesic, or narcotic medication within 24 hours before the procedure
- Willingness of both the child and parent to participate in the study
Who cannot join
- Child's refusal to participate or continue the assessment process
- Parent's request to withdraw from the study
- Inability to complete the blood draw procedure in a single attempt
- Missing essential data required for analysis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Faculty of Health Sciences
Köseköy, Kocaeli
About this study
Official title: The Effect of Buzzy® and a Cognitive Behavioral Intervention Package on Pain and Fear During Blood Draw in Children: A Three-Arm Randomized Controlled Trial
This study evaluated the effects of Buzzy® and a Cognitive Behavioral Intervention Package on pain and fear/anxiety during blood draw in children aged 7-12 years. Blood draw is a common procedure in children, but it may cause pain, fear, and anxiety. Non-pharmacological methods may help children cope better with this procedure.
Children were randomly assigned to one of three groups: a control group, a Cognitive Behavioral Intervention Package group, or a Buzzy® group. Children in the control group received routine blood draw care. Children in the Cognitive Behavioral Intervention Package group received preparation, age-appropriate information, distraction, supportive guidance, parent support, and positive reinforcement. Children in the Buzzy® group received cold and vibration application before and during the blood draw procedure.
Pain and fear/anxiety levels were assessed by child self-report before and immediately after the blood draw. The study aimed to determine whether Buzzy® and the Cognitive Behavioral Intervention Package reduce pain and fear/anxiety compared with routine care.
Read the detailed description
Needle-related procedures are among the most common sources of procedural pain, fear, and anxiety in children. Blood draw is a short but stressful procedure, and children may experience distress due to needle fear, previous negative experiences, uncertainty about the procedure, and limited coping skills. Poorly managed procedural pain and fear may negatively affect children's future responses to medical procedures.
This study focuses on two non-pharmacological approaches that may support children during blood draw. Buzzy® combines cold and vibration and is intended to reduce pain perception through sensory stimulation. The Cognitive Behavioral Intervention Package includes preparation, age-appropriate information, distraction, supportive communication, parent involvement, and positive reinforcement to help the child cope with the procedure.
The study was designed as a three-arm randomized controlled trial conducted in a pediatric blood drawing unit. The intervention procedures were applied within the routine clinical workflow of the unit. Pain and fear/anxiety were evaluated using child self-report measures before and immediately after the blood draw. By comparing Buzzy®, the Cognitive Behavioral Intervention Package, and routine care, this study aims to provide evidence for practical, child-friendly, and non-pharmacological strategies that can be used by healthcare professionals during pediatric blood draw procedures.
- Conditions
- Procedural Pain, Procedural Fear, Procedural Anxiety
- Being tested
- Cognitive Behavioral Intervention Package, Buzzy®
- Keywords
- Blood Draw, Buzzy®, Children, Cognitive Behavioral Intervention Package, Procedural Anxiety, Procedural Pain, Randomized Controlled Trial
- Medical subject headings
- Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Intervention PackageBehavioural
The Cognitive Behavioral Intervention Package is a structured, non-pharmacological behavioral intervention applied before, during, and after the blood draw procedure. Before the procedure, the researcher provides age-appropriate information about the blood draw, answers the child's questions, gives supportive suggestions, guides the parent on how to support the child, and helps the child choose a distraction technique. During the blood draw, the selected distraction technique, such as counting, singing, reciting a short poem, or answering questions, is applied with researcher support. After the procedure, the child receives positive verbal feedback and a symbolic reward.
Buzzy®Device
Buzzy® is a non-pharmacological device that combines cold and vibration. In this study, Buzzy® was applied 60 seconds before the blood draw procedure and continued during the procedure. During venipuncture, the device was placed approximately 3 cm proximal to the blood draw site.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Intervention Package Group | Experimental | Children in this group received the Cognitive Behavioral Intervention Package in addition to routine blood draw care. The package included age-appropriate preparation and information about the blood draw procedure, pre-procedural distraction, supportive suggestions, parent guidance, distraction during the procedure, and positive reinforcement after the procedure. During the procedure, the child used a selected distraction technique, such as counting, singing, reciting a short poem, or answering questions, with researcher support. Receives: Behavioral: Cognitive Behavioral Intervention Package |
| Buzzy® Group | Experimental | Children in this group received Buzzy® in addition to routine blood draw care. Buzzy® is a non-pharmacological device that combines cold and vibration. The device was applied 60 seconds before the blood draw and was continued during the procedure. During venipuncture, Buzzy® was placed approximately 3 cm proximal to the blood draw site. Receives: Device: Buzzy® |
| Control Group | No intervention | Children in this group received routine blood draw care according to the standard procedure of the pediatric blood drawing unit. No additional non-pharmacological intervention, such as Buzzy® or the Cognitive Behavioral Intervention Package, was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker FACES Pain Rating Scale Score
Pain intensity was assessed using the Wong-Baker FACES® Pain Rating Scale, a single-item child self-report measure consisting of six faces. In this study, the faces were scored from 0 (no pain) to 5 (the most severe pain). The total score ranges from 0 to 5, with higher scores indicating greater pain intensity and therefore a worse outcome. Children reported their pain immediately before and immediately after the blood draw procedure.
Measured: Immediately before and immediately after the blood draw procedure
Children's Fear Scale Score
Fear was assessed using the Children's Fear Scale, a single-item child self-report measure consisting of five faces scored from 0 (no fear) to 4 (extreme fear). The total score ranges from 0 to 4, with higher scores indicating greater fear and therefore a worse outcome. Children reported their fear immediately before and immediately after the blood draw procedure.
Measured: Immediately before and immediately after the blood draw procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start10 Jan 2025
- Primary completion24 Apr 2026
- Study completion24 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Procedural 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgul Erdogan, Kocaeli University
- Investigators
- Birgül Erdoğan, Principal investigator, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689370
- Sponsor's protocol ID
- KOU-GOKAEK-2024-16-13
- Status last verified
- Sep 2026
- First submitted
- 1 Jul 2026
- Last updated
- 15 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Buzzy® and a Cognitive Behavioral Intervention Package on Pain and Fear During Blood Draw in Children: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07689370
- Acronym / sponsor ID
- KOU-GOKAEK-2024-16-13
- Conditions
- Procedural Pain, Procedural Fear, Procedural Anxiety
- Keywords
- Blood Draw, Buzzy®, Children, Cognitive Behavioral Intervention Package, Procedural Anxiety, Procedural Pain, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 24 Apr 2026 (actual)
- Study completion
- 24 Apr 2026 (actual)
- First posted
- 8 Jul 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.
This study evaluated the effects of Buzzy® and a Cognitive Behavioral Intervention Package on pain and fear/anxiety during blood draw in children aged 7-12 years. Blood draw is a common procedure in children, but it may cause pain, fear, and anxiety. Non-pharmacological methods may help children cope better with this procedure.
Children were randomly assigned to one of three groups: a control group, a Cognitive Behavioral Intervention Package group, or a Buzzy® group. Children in the control group received routine blood draw care. Children in the Cognitive Behavioral Intervention Package group received preparation, age-appropriate information, distraction, supportive guidance, parent support, and positive reinforcement. Children in the Buzzy® group received cold and vibration application before and during the blood draw procedure.
Pain and fear/anxiety levels were assessed by child self-report before and immediately after the blood draw. The study aimed to determine whether Buzzy® and the Cognitive Behavioral Intervention Package reduce pain and fear/anxiety compared with routine care.
Detailed description
Needle-related procedures are among the most common sources of procedural pain, fear, and anxiety in children. Blood draw is a short but stressful procedure, and children may experience distress due to needle fear, previous negative experiences, uncertainty about the procedure, and limited coping skills. Poorly managed procedural pain and fear may negatively affect children's future responses to medical procedures.
This study focuses on two non-pharmacological approaches that may support children during blood draw. Buzzy® combines cold and vibration and is intended to reduce pain perception through sensory stimulation. The Cognitive Behavioral Intervention Package includes preparation, age-appropriate information, distraction, supportive communication, parent involvement, and positive reinforcement to help the child cope with the procedure.
The study was designed as a three-arm randomized controlled trial conducted in a pediatric blood drawing unit. The intervention procedures were applied within the routine clinical workflow of the unit. Pain and fear/anxiety were evaluated using child self-report measures before and immediately after the blood draw. By comparing Buzzy®, the Cognitive Behavioral Intervention Package, and routine care, this study aims to provide evidence for practical, child-friendly, and non-pharmacological strategies that can be used by healthcare professionals during pediatric blood draw procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Intervention Package Group | Experimental | Behavioral: Cognitive Behavioral Intervention PackageChildren in this group received the Cognitive Behavioral Intervention Package in addition to routine blood draw care. The package included age-appropriate preparation and information about the blood draw procedure, pre-procedural distraction, supportive suggestions, parent guidance, distraction during the procedure, and positive reinforcement after the procedure. During the procedure, the child used a selected distraction technique, such as counting, singing, reciting a short poem, or answering questions, with researcher support. |
| Buzzy® Group | Experimental | Device: Buzzy®Children in this group received Buzzy® in addition to routine blood draw care. Buzzy® is a non-pharmacological device that combines cold and vibration. The device was applied 60 seconds before the blood draw and was continued during the procedure. During venipuncture, Buzzy® was placed approximately 3 cm proximal to the blood draw site. |
| Control Group | No intervention | –Children in this group received routine blood draw care according to the standard procedure of the pediatric blood drawing unit. No additional non-pharmacological intervention, such as Buzzy® or the Cognitive Behavioral Intervention Package, was applied. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 7 to 12 years
- Able to read and write
- No chronic disease
- No visual, hearing, verbal communication, cognitive, or neurological impairment
- No use of sedative, analgesic, or narcotic medication within 24 hours before the procedure
Key exclusion criteria (4 listed)
- Child's refusal to participate or continue the assessment process
- Parent's request to withdraw from the study
- Inability to complete the blood draw procedure in a single attempt
- Missing essential data required for analysis
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 |
|---|---|---|
| Cognitive Behavioral Intervention PackageThe Cognitive Behavioral Intervention Package is a structured, non-pharmacological behavioral intervention applied before, during, and after the blood draw procedure. Before the procedure, the researcher provides age-appropriate information about the blood draw, answers the child's questions, gives supportive suggestions, guides the parent on how to support the child, and helps the child choose a distraction technique. During the blood draw, the selected distraction technique, such as counting, singing, reciting a short poem, or answering questions, is applied with researcher support. After the procedure, the child receives positive verbal feedback and a symbolic reward. | Behavioural | Cognitive Behavioral Intervention Package Group |
| Buzzy®Buzzy® is a non-pharmacological device that combines cold and vibration. In this study, Buzzy® was applied 60 seconds before the blood draw procedure and continued during the procedure. During venipuncture, the device was placed approximately 3 cm proximal to the blood draw site. | Device | Buzzy® Group |
Primary outcome
Wong-Baker FACES Pain Rating Scale Score
Time frame: Immediately before and immediately after the blood draw procedure
Pain intensity was assessed using the Wong-Baker FACES® Pain Rating Scale, a single-item child self-report measure consisting of six faces. In this study, the faces were scored from 0 (no pain) to 5 (the most severe pain). The total score ranges from 0 to 5, with higher scores indicating greater pain intensity and therefore a worse outcome. Children reported their pain immediately before and immediately after the blood draw procedure.
Children's Fear Scale Score
Time frame: Immediately before and immediately after the blood draw procedure
Fear was assessed using the Children's Fear Scale, a single-item child self-report measure consisting of five faces scored from 0 (no fear) to 4 (extreme fear). The total score ranges from 0 to 4, with higher scores indicating greater fear and therefore a worse outcome. Children reported their fear immediately before and immediately after the blood draw 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 15 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.
Birgül Erdoğan principal investigator
Kocaeli 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 Cognitive Behavioral Intervention Package and Buzzy® in people with Procedural Pain and Procedural Fear, run by Kocaeli 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 6 inclusion and 4 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 15 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?
Wong-Baker FACES Pain Rating Scale Score (time frame: Immediately before and immediately after the blood draw 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 15 Sep 2026.