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COMPLETED
NCT07689370
NA

Buzzy® and Cognitive Behavioral Intervention Package During Blood Draw in Children

Sponsor: Kocaeli University

View on ClinicalTrials.gov

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. 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.

Official title: The Effect of Buzzy® and a Cognitive Behavioral Intervention Package on Pain and Fear/Anxiety During Blood Draw in Children: A Three-Arm Randomized Controlled Trial

Key Details

Gender

All

Age Range

7 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-01-10

Completion Date

2026-04-24

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Cognitive Behavioral Intervention Package

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.

DEVICE

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.

Locations (1)

Kocaeli University Faculty of Health Sciences

Köseköy, Kocaeli, Turkey (Türkiye)