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Completed
NCT07689370
Buzzy® and Cognitive Behavioral Intervention Package During Blood Draw in Children
Conditions: Procedural Pain, Procedural Fear, Procedural Anxiety
Sex: All
Ages: 7 Years – 12 Years
Healthy volunteers: No
Phase: NA
Enrollment: 180
Sponsor: Kocaeli University
Location: Kocaeli University Faculty of Health Sciences Köseköy Kocaeli
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07689370). StuddyBuddy aggregates publicly available trial information.