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NCT Number: NCT07689370

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

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.

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Key information

Conditions

Procedural Pain Neurologic Manifestations Pain Pain, Procedural Pathological Conditions, Signs and Symptoms Procedural Anxiety Procedural Fear Signs and Symptoms

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University Faculty of Health Sciences

Köseköy, Kocaeli, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 7 to 12 years
  • Able to read and write
  • No chronic disease
  • No visual, hearing, verbal communication, cognitive, or neurological impairment
  • No use of sedative, analgesic, or narcotic medication within 24 hours before the procedure
  • Willingness of both the child and parent to participate in the study

Exclusion criteria

  • Child's refusal to participate or continue the assessment process
  • Parent's request to withdraw from the study
  • Inability to complete the blood draw procedure in a single attempt
  • Missing essential data required for analysis

Treatment and study plan

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.

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.

Primary outcomes

  1. Wong-Baker FACES Pain Rating Scale Score

    Time frame: Immediately before and immediately after the blood draw procedure

    Pain intensity was assessed using the Wong-Baker FACES® Pain Rating Scale, a single-item child self-report measure consisting of six faces scored from 0 (no hurt) to 10 (hurts worst), in 2-point increments. The total score ranges from 0 to 10, with higher scores indicating greater pain intensity and therefore a worse outcome. Children reported their pain immediately before and immediately after the blood draw procedure.

  2. Children's Fear Scale Score

    Time frame: Immediately before and immediately after the blood draw procedure

    Fear was assessed using the Children's Fear Scale, a single-item child self-report measure consisting of five faces scored from 0 (no fear) to 4 (extreme fear). The total score ranges from 0 to 4, with higher scores indicating greater fear and therefore a worse outcome. Children reported their fear immediately before and immediately after the blood draw procedure.

  3. Children's Anxiety Scale Score

    Time frame: Immediately before and immediately after the blood draw procedure

    Anxiety was assessed using the Children's Anxiety Scale-State, a single-item child self-report measure presented in a thermometer-like format and scored from 0 (no anxiety) to 10 (highest possible anxiety). The total score ranges from 0 to 10, with higher scores indicating greater state anxiety and therefore a worse outcome. Children reported their anxiety immediately before and immediately after the blood draw procedure.

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 8, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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