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

NCT07689370 | Completed

• 1 other identifier: KOU-GOKAEK-2024-16-13
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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 Fear; Procedural Anxiety; Procedural Pain

Keywords

Blood Draw; Buzzy®; Children; Cognitive Behavioral Intervention Package; Procedural Anxiety; Procedural Pain; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• Wong-Baker FACES Pain Rating Scale Score

  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.

  Immediately before and immediately after the blood draw procedure

• Children's Fear Scale Score

  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.

  Immediately before and immediately after the blood draw procedure

• Children's Anxiety Scale Score

  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.

  Immediately before and immediately after the blood draw procedure

Study Arms (3)

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.

Behavioral: Cognitive Behavioral Intervention Package

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.

Device: Buzzy®

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.

Interventions

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.

Cognitive Behavioral Intervention Package Group

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.

Buzzy® Group

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Faculty of Health Sciences

Köseköy, Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Birgül Erdoğan

  Kocaeli University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor, PhD, RN

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: January 10, 2025
• Primary Completion: April 24, 2026
• Study Completion: April 24, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)