None listed
Conditions
Brief summary
A Randomised Control Trial (RCT) to compare a Therapeutic Goods Administration (TGA)-approved product (Buzzy device) to current standard practice. The Buzzy device is a small plastic device that vibrates and has a small cold pack attached. The Buzzy device is theorised to reduce pain (and therefore the negative association) with cannulation. It has been proven effective in children but the role of the Buzzy device in adults is less clear.
Interventions
The Frozen Buzzy® device is a non-pharmacological pain-relief tool that combines cold therapy with vibration. When applied to the skin, it delivers a cooling effect alongside vibratory stimulation.
Following randomisation, participants allocated to the intervention group will have the Buzzy® device attached to the cannulation arm for 30-120 seconds (per the product instruction manual), proximal to the intended cannulation site. The device will be activated (vibration on) prior to the cannulation
The Frozen Buzzy® device is a non-pharmacological pain-relief tool that combines cold therapy with vibration. When applied to the skin, it delivers a cooling effect alongside vibratory stimulation. Following randomisation, participants allocated to the intervention group will have the Buzzy® device attached to the cannulation arm for 30-120 seconds (per the product instruction manual), proximal to the intended cannulation site. The device will be activated (vibration on) prior to the cannulation attempt and deactivated immediately following successful cannulation If there is a significant delay between cannulation attempts, the vibrating function will be switched off during the interval. Adherence to the intervention will be monitored by members of the research team through direct supervision of the cannulation process and administration of the Buzzy® device.
Sponsors
Limestone Coast Local Health Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Adults 18-50 years 2. Scheduled for elective general anaesthetic or elective sedation anaesthetic, requiring intravenous access prior to anaesthesia 3. Self-reported to be ‘anxious’ about upcoming cannulation 4. Able to provide informed consent for study participation
Exclusion criteria
1. Cognitive impairment prohibiting engagement in protocol and/or providing informed consent 2. Received premedication / anxiolytic within 24 hours of procedure 3. Non-elective patients 4. Patient requiring or requesting topical local anaesthetic at the cannulation site
Outcome results
None listed