The Effect of Methods Used During Blood Collection on Pain and Fear in Children (NCT06953531) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effect of Methods Used During Blood Collection on Pain and Fear in Children
88 participantsStarted 2025-05-12
Plain-language 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.
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wong-Baker Facial Expressions Rating Scale
Timeframe: At the time of blood collection (0 minutes) and 5 minutes after the procedure
2
Children's Fear Scale
Timeframe: Immediately before and during the blood collection procedure.