None listed
Conditions
Brief summary
This prospective interventional study evaluates the effectiveness of the Buzzy device compared with EMLA cream in managing pain and anxiety during peripheral venous blood sampling in children. Participants undergoing venipuncture receive either the Buzzy device or standard topical anesthesia with EMLA cream. Pain and anxiety are assessed using the Faces Pain Scale and the Scary Scale immediately before and after the procedure. The study uses an active control design and reflects routine clinical practice in a hospital setting. Findings aim to inform evidence-based strategies for improving comfort and reducing distress in pediatric venous procedures.
Interventions
Children in the intervention group receive peripheral venous blood sampling using the Buzzy device in addition to standard care. Standard care consists of topical anaesthetic EMLA (Romla) cream applied to the venipuncture site prior to the procedure, followed by routine venipuncture performed by a trained paediatric nurse (skin antisepsis, appropriate positioning, and standard comfort or distraction techniques; no additional pharmacological analgesia). The Buzzy device, which combines local vibr
Children in the intervention group receive peripheral venous blood sampling using the Buzzy device in addition to standard care. Standard care consists of topical anaesthetic EMLA (Romla) cream applied to the venipuncture site prior to the procedure, followed by routine venipuncture performed by a trained paediatric nurse (skin antisepsis, appropriate positioning, and standard comfort or distraction techniques; no additional pharmacological analgesia). The Buzzy device, which combines local vibration and cold stimulation, is applied proximally to the venipuncture site according to the manufacturer’s instructions, positioned above the puncture site approximately 30–60 seconds before needle insertion and kept in place throughout the venipuncture procedure.
Sponsors
Iuliu Hatieganu University of Medcine and Pharmacy
Study design
Allocation
Non-randomised trial
Primary purpose
Educational / counselling / training
Eligibility
Sex/Gender
All
Age
7 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
Children requiring peripheral venous blood sampling Age range as defined in the study protocol (7–13 years) Children accompanied by a parent or legal guardian Use of either the Buzzy device or Romla cream as part of routine care Ability of the child to self-report pain and anxiety using the Faces Pain Scale and Scary Scale Written informed consent obtained from the parent or legal guardian Child assent obtained when appropriate
Exclusion criteria
Children with cognitive impairment or developmental delay that prevents reliable use of the Faces Pain Scale or Scary Scale Children receiving sedation or analgesia other than the study interventions Children with chronic pain conditions or acute severe illness at the time of blood sampling Emergency situations requiring immediate venous access Previous participation in the study Refusal of the child or parent/guardian to participate
Outcome results
None listed