Painpain and fearNCT06953531
The Effect of Methods Used During Blood Collection on Pain and Fear in Children
A study testing Cold Application (Local Skin Cooling Device), Distraction Method (Bubble Machine) and Distraction Method (Simulative Toy) in people with Pain and Fear, run by Hatice ŞEN.
Trial summary
The effect of three different methods (local skin cooling device, bubble machine, simulative toy) that will be used during the blood collection procedure on pain, fear and procedure time will be investigated in pain-sensitive 6-12 age group children. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- What is being tested?
- Cold Application (Local Skin Cooling Device), Distraction Method (Bubble Machine) and Distraction Method (Simulative Toy)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 12 May 2025to 31 Dec 2025
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child must be between the ages of 6 and 12.
- The child's WB-YİDÖ score must be 0 before the blood collection procedure.
- The child must be willing to participate in the study and sign the Informed Consent Form/Written Consent Form.
- The child must be able to speak Turkish.
- The child must not have a mental disability and must be able to use their arms functionally.
- The child must not have used sedatives, analgesics, or narcotics within 6 hours prior to admission to the blood collection unit.
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- The child's body temperature must be below 38 °C at the time of admission to the blood collection unit.
- The child must have undergone blood collection procedures before.
- The child must not be afraid of the simulation toy.
Who cannot join
- Failure to sign the Informed Consent Form/Written Consent Form.
- The child has a disease that causes chronic pain.
- The child has vision or hearing problems.
- Deterioration of skin integrity in the blood collection area or in the area where the local skin cooling device will be applied.
- Presence of nerve damage in the area where blood will be drawn.
- Having sensory motor deficit, diabetes, peripheral vascular disease (e.g., Raynaud's syndrome), neuropathy, or sickle cell anemia.
- The child has an allergy to the simulative toy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Three Different Methods Used During Blood Collection in Children on Pain, Fear and Procedure Time
The effect of three different methods (local skin cooling device, bubble machine, simulative toy) that will be used during the blood collection procedure on pain, fear and procedure time will be investigated in pain-sensitive 6-12 age group children.
Read the detailed description
Children are usually admitted to the hospital for diagnosis, treatment or follow-up at an early stage of their lives and are subjected to various invasive procedures during this process. Blood collection is one of the interventions that are repeated many times by children during diagnosis and treatment, causing a feeling of pain and fear. Although bloodletting may seem like a minor procedure, it is considered a source of great fear by children and therefore turns into an unpleasant experience by both children and their families.
Pain management is both an ethical obligation and a child's right, which should be done by focusing on the needs and preferences of children and their parents, requires accurate and effective planning. Nonpharmacological treatment methods used in pain management in children are classified into three groups: physical, supportive and cognitive-behavioral methods. The use of Coolsense, a local skin cooling device, is a method that can be used in this sense in terms of its rapid effect. Coolsense; it is a hand-held device that has an effect in as little as five seconds, does not contain chemicals, has a temperature-controlled head, can be stored in the freezer of refrigerators and used repeatedly. Among the advantages of the device are that it is easy to use, it is applied to a small area and it is easy to Decipher whether it is at the right temperature from the light burning on it. The most preferred method among cognitive-behavioral methods is the method of diverting attention Decently. The method of diverting attention is divided into two as active and passive methods. One of the methods of attracting active attention is the use of toys. One of these toys is a bubble machine. The bubble machine is a toy with the ability to produce a large number of bubbles at the same time with its multi-hole design. With this toy, the child focuses on the bubbles that come out through the bubble machine, and not on the painful process, so his attention is diverted from the blood collection process. Another one of the toys is a simulative toy. Simulative toy; it is a toy that can show realistic and vivid features, contains sensors sensitive to touch and movement, breathes, can open and close its eyes, can move its head and body, and at the same time make sounds as if it were real. With these features, it can be effective in reducing pain and fear by ensuring that children's attention is diverted from the painful procedure. It is thought that three different methods (local skin cooling device, bubble machine, simulative toy) that will be used during the blood collection procedure in pain-sensitive 6-12 age group children may have a positive effect on pain, fear and procedure time.
- Being tested
- Cold Application (Local Skin Cooling Device), Distraction Method (Bubble Machine), Distraction Method (Simulative Toy)
- Keywords
- Blood collection process in children, Nursing
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Application (Local Skin Cooling Device)Device
Immediately before the blood collection procedure, cold application will be made to the area with a local skin cooling device.
Distraction Method (Bubble Machine)Behavioural
A bubble machine will be used to distract children during the blood collection process.
Distraction Method (Simulative Toy)Behavioural
A simulative toy will be used to distract children during the blood collection process.
| Study group | Role | What they receive |
|---|---|---|
| Local Skin Cooling Device Group | Experimental | Participants are given a cold application using a local skin cooling device just before the blood collection process. Receives: Device: Cold Application (Local Skin Cooling Device) |
| Bubble Machine Group | Experimental | During the blood collection process, participants are entertained with the bubble machine. Receives: Behavioral: Distraction Method (Bubble Machine) |
| Simulative Toy Group | Experimental | During the blood collection process, participants are distracted with a simulative toy. Receives: Behavioral: Distraction Method (Simulative Toy) |
| Control Group | No intervention | Participants are not subjected to any intervention during the blood collection process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Facial Expressions Rating Scale
The Wong-Baker Facial Expressions Rating Scale will be used to assess the pain levels of children during the blood collection procedure and 5 minutes after the procedure. The scale includes six facial expressions representing increasing levels of pain, scored from 0 (no pain) to 5 or 10 (severe pain), depending on the version used.
Measured: At the time of blood collection (0 minutes) and 5 minutes after the procedure
Children's Fear Scale
The Child Fear Scale, which is suitable for children aged 3 to 16, will be used to assess the level of fear and anxiety experienced by the child before and during the blood collection. The scale consists of five facial expressions scored from 0 (no fear and anxiety) to 4 (highest fear and anxiety), and can be administered by children, parents, or researchers.
Measured: Immediately before and during 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 posted1 May 2025
- Study start12 May 2025 (estimated)
- Primary completion28 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hatice ŞEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice ŞEN, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953531
- Sponsor's protocol ID
- University Mersin
- Acronym
- pain and fear
- Status last verified
- Apr 2025
- First submitted
- 20 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Three Different Methods Used During Blood Collection in Children on Pain, Fear and Procedure Time
- ClinicalTrials.gov ID
- NCT06953531
- Acronym / sponsor ID
- pain and fear / University Mersin
- Keywords
- Blood collection process in children, Nursing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hatice ŞENUniversity, hospital or other
- Study start
- 12 May 2025 (estimated)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 May 2025 (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 effect of three different methods (local skin cooling device, bubble machine, simulative toy) that will be used during the blood collection procedure on pain, fear and procedure time will be investigated in pain-sensitive 6-12 age group children.
Detailed description
Children are usually admitted to the hospital for diagnosis, treatment or follow-up at an early stage of their lives and are subjected to various invasive procedures during this process. Blood collection is one of the interventions that are repeated many times by children during diagnosis and treatment, causing a feeling of pain and fear. Although bloodletting may seem like a minor procedure, it is considered a source of great fear by children and therefore turns into an unpleasant experience by both children and their families.
Pain management is both an ethical obligation and a child's right, which should be done by focusing on the needs and preferences of children and their parents, requires accurate and effective planning. Nonpharmacological treatment methods used in pain management in children are classified into three groups: physical, supportive and cognitive-behavioral methods. The use of Coolsense, a local skin cooling device, is a method that can be used in this sense in terms of its rapid effect. Coolsense; it is a hand-held device that has an effect in as little as five seconds, does not contain chemicals, has a temperature-controlled head, can be stored in the freezer of refrigerators and used repeatedly. Among the advantages of the device are that it is easy to use, it is applied to a small area and it is easy to Decipher whether it is at the right temperature from the light burning on it. The most preferred method among cognitive-behavioral methods is the method of diverting attention Decently. The method of diverting attention is divided into two as active and passive methods. One of the methods of attracting active attention is the use of toys. One of these toys is a bubble machine. The bubble machine is a toy with the ability to produce a large number of bubbles at the same time with its multi-hole design. With this toy, the child focuses on the bubbles that come out through the bubble machine, and not on the painful process, so his attention is diverted from the blood collection process. Another one of the toys is a simulative toy. Simulative toy; it is a toy that can show realistic and vivid features, contains sensors sensitive to touch and movement, breathes, can open and close its eyes, can move its head and body, and at the same time make sounds as if it were real. With these features, it can be effective in reducing pain and fear by ensuring that children's attention is diverted from the painful procedure. It is thought that three different methods (local skin cooling device, bubble machine, simulative toy) that will be used during the blood collection procedure in pain-sensitive 6-12 age group children may have a positive effect on pain, fear and procedure time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Local Skin Cooling Device Group | Experimental | Device: Cold Application (Local Skin Cooling Device)Participants are given a cold application using a local skin cooling device just before the blood collection process. |
| Bubble Machine Group | Experimental | Behavioral: Distraction Method (Bubble Machine)During the blood collection process, participants are entertained with the bubble machine. |
| Simulative Toy Group | Experimental | Behavioral: Distraction Method (Simulative Toy)During the blood collection process, participants are distracted with a simulative toy. |
| Control Group | No intervention | –Participants are not subjected to any intervention during the blood collection process. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- The child must be between the ages of 6 and 12.
- The child's WB-YİDÖ score must be 0 before the blood collection procedure.
- The child must be willing to participate in the study and sign the Informed Consent Form/Written Consent Form.
- The child must be able to speak Turkish.
- The child must not have a mental disability and must be able to use their arms functionally.
Key exclusion criteria (7 listed)
- Failure to sign the Informed Consent Form/Written Consent Form.
- The child has a disease that causes chronic pain.
- The child has vision or hearing problems.
- Deterioration of skin integrity in the blood collection area or in the area where the local skin cooling device will be applied.
- Presence of nerve damage in the area where blood will be drawn.
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 |
|---|---|---|
| Cold Application (Local Skin Cooling Device)Immediately before the blood collection procedure, cold application will be made to the area with a local skin cooling device. | Device | Local Skin Cooling Device Group |
| Distraction Method (Bubble Machine)A bubble machine will be used to distract children during the blood collection process. | Behavioural | Bubble Machine Group |
| Distraction Method (Simulative Toy)A simulative toy will be used to distract children during the blood collection process. | Behavioural | Simulative Toy Group |
Primary outcome
Wong-Baker Facial Expressions Rating Scale
Time frame: At the time of blood collection (0 minutes) and 5 minutes after the procedure
The Wong-Baker Facial Expressions Rating Scale will be used to assess the pain levels of children during the blood collection procedure and 5 minutes after the procedure. The scale includes six facial expressions representing increasing levels of pain, scored from 0 (no pain) to 5 or 10 (severe pain), depending on the version used.
Children's Fear Scale
Time frame: Immediately before and during the blood collection procedure.
The Child Fear Scale, which is suitable for children aged 3 to 16, will be used to assess the level of fear and anxiety experienced by the child before and during the blood collection. The scale consists of five facial expressions scored from 0 (no fear and anxiety) to 4 (highest fear and anxiety), and can be administered by children, parents, or researchers.
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 1 May 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Application (Local Skin Cooling Device), Distraction Method (Bubble Machine) and Distraction Method (Simulative Toy) in people with Pain and Fear, run by Hatice ŞEN.
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 7 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 1 May 2025. 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 Hatice ŞEN Research Assıstant (+90 507 520 78 30, Haticesen3303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wong-Baker Facial Expressions Rating Scale (time frame: At the time of blood collection (0 minutes) and 5 minutes after the 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 1 May 2025.