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What is this study about, in short?
This study looks at simple, no-cost ways to reduce the pain and fear that children aged 6-12 feel when they have blood drawn at the hospital. Two methods are being tested:
These methods need no medicine and no device, so they can be used easily in any hospital. The study aims to find out whether these two methods really reduce pain and fear, by comparing them with a group that receives no extra method.
Why is this study being done? Drawing blood is one of the most common painful procedures in children. Fear of needles is very common and can even lead a person to avoid health care later in life. So it matters to make the blood-draw experience easier for children.
Some methods used to reduce pain have practical limits:
For these reasons, there is a need for simple methods that cost nothing, need no device, and can be applied easily in any setting. This study tests exactly that.
How do the methods work? (Simple science) Both methods rest on an idea called the "Gate Control Theory": in our body, the sense of touch and vibration competes with the sense of pain on the way to the brain. Gentle touch or mild vibration can act like a "gate" that partly blocks the pain signal from reaching the brain.
Who can take part in the study?
Can take part:
Cannot take part, or will be withdrawn:
What will happen if my child takes part?
The blood draw will happen anyway because it is medically needed. The study only adds the method used during the draw and a short measurement afterward. Step by step:
The three groups are:
Group What is done in this group?
Where and when will the study take place?
Taking part is completely voluntary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rhythmic Skin Tapping | Experimental | Rhythmic tapping with the fingertips will be applied proximal to the procedure site. |
|
| Internal Vibration (Humming) | Experimental | The child will be asked to make an "mmmm" sound during the venipuncture procedure. |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhythmic Skin Tapping | Behavioral | Rhythmic tapping with the fingertips will be applied proximal to the procedure site. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity during the blood-draw procedure (Wong-Baker FACES Pain Rating Scale) | Self-reported pain intensity assessed with the Wong-Baker FACES Pain Rating Scale, scored 0-10 (0 = no pain, 10 = worst pain). Higher scores indicate greater pain. Assessed once, immediately after the procedure. | Immediately after the venipuncture procedure (single assessment, within ~1 minute) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural fear during the blood-draw procedure (Children's Fear Scale) | Immediately after the venipuncture procedure (single assessment, within ~1 minute) | Fear level assessed with the Children's Fear Scale (CFS), a single-item 5-face visual scale scored 0-4 (0 = no fear, 4 = severe fear). Higher scores indicate greater fear. Assessed once, immediately after the procedure. |
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Inclusion Criteria:
Requiring a peripheral venipuncture procedure
Having written informed consent from the parents
Having verbal assent from the child
Being able to speak and understand Turkish
Having a cognitive development level appropriate for age
Absence of any chronic pain condition
Exclusion Criteria:
Development of complications during the procedure
Having used analgesics within the last 24 hours
Having previously participated in the same study
Impaired skin integrity at the procedure site
Having a neurological or psychiatric diagnosis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mustafa Volkan DÜZGÜN, PhD | Contact | +905079967991 | mvolkanduzgun@gmail.com |
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| Internal Vibration (Humming) | Behavioral | The child will be asked to make an "mmmm" sound during the venipuncture procedure. |
|
| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| D059787 | Acute Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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