Buzzy® and Cognitive Behavioral Intervention Package During Blood Draw in Children
The Effect of Buzzy® and a Cognitive Behavioral Intervention Package on Pain and Fear During Blood Draw in Children: A Three-Arm Randomized Controlled Trial
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kocaeli
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Köseköy, Kocaeli, 터키 (Türkiye)
- Kocaeli University Faculty of Health Sciences
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Cognitive Behavioral Intervention Package Group
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.
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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.
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실험적: Buzzy® Group
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.
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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.
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간섭 없음: Control Group
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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Children's Fear Scale Score
기간: Immediately before and immediately after the blood draw procedure
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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.
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Immediately before and immediately after the blood draw procedure
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Wong-Baker FACES Pain Rating Scale Score
기간: Immediately before and immediately after the blood draw procedure
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Pain intensity was assessed using the Wong-Baker FACES® Pain Rating Scale, a single-item child self-report measure consisting of six faces.
In this study, the faces were scored from 0 (no pain) to 5 (the most severe pain).
The total score ranges from 0 to 5, 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.
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Immediately before and immediately after the blood draw procedure
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Birgül Erdoğan, Kocaeli University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- KOU-GOKAEK-2024-16-13
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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