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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Kocaeli
-
Köseköy, Kocaeli, Turkije (Türkiye)
- Kocaeli University Faculty of Health Sciences
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Experimenteel: 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.
|
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.
|
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Children's Fear Scale Score
Tijdsspanne: 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.
|
Immediately before and immediately after the blood draw procedure
|
|
Wong-Baker FACES Pain Rating Scale Score
Tijdsspanne: 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.
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.
|
Immediately before and immediately after the blood draw procedure
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Birgül Erdoğan, Kocaeli University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- KOU-GOKAEK-2024-16-13
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .