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

NCT07689370 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-07-24

No results posted yet for this study

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.

Conditions

  • Procedural Pain
  • Procedural Fear
  • Procedural Anxiety

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.

Sponsors & Collaborators

  • Kocaeli University

    lead OTHER

Principal Investigators

  • Birgül Erdoğan · Kocaeli University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-10
Primary Completion
2026-04-24
Completion
2026-04-24

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07689370 on ClinicalTrials.gov