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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Intervention Package | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wong-Baker FACES Pain Rating Scale Score | Pain was assessed using the Wong-Baker FACES Pain Rating Scale. The scale ranges from 0 to 5, with higher scores indicating greater pain. Pain scores were evaluated by child self-report immediately before and immediately after the blood draw procedure. | Immediately before and immediately after the blood draw procedure |
| Children's Fear Scale Score | Fear was assessed using the Children's Fear Scale. The scale ranges from 0 to 4, with higher scores indicating greater fear. Fear scores were evaluated by child self-report immediately before and immediately after the blood draw procedure. | Immediately before and immediately after the blood draw procedure |
| Children's Anxiety Scale Score | Immediately before and immediately after the blood draw procedure | Anxiety was assessed using the Children's Anxiety Scale. Higher scores indicate greater anxiety. Anxiety scores were evaluated by child self-report immediately before and immediately after the blood draw procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birgül Erdoğan | Kocaeli University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kocaeli University Faculty of Health Sciences | Köseköy | Kocaeli | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000073818 | Pain, Procedural |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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. |
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