Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000599370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/04/2026
Date registered
Help: Date registered
13/05/2026
Date last updated
Help: Date last updated
13/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/05/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of the ‘Buzzy’ High-Frequency Vibration Device on Cannula-Related Anxiety for Young Adults Undergoing Anaesthetic: A Randomised Control Trial
Scientific title
Effectiveness of the ‘Buzzy’ High-Frequency Vibration Device on Cannula-Related Anxiety for Young Adults Undergoing Anaesthetic: A Randomised Control Trial
Additional trial identifiers [1] 317124 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Self-reported anxiety 341679 0
Condition category
Condition code
Mental Health 337770 337770 0 0
Anxiety
Anaesthesiology 337860 337860 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
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.
Intervention code [1] 333887 0
Treatment: Devices
Description of the comparator or control
Routine IV cannulation without distractors, ice packs or any other form of anxiolytic.
Control group
Active

Outcomes
Primary outcome [1] 345220 0
Participant self-reported pain
Timepoint [1] 345220 0
Baseline (prior to cannulation) and immediately after cannulation
Primary outcome [2] 345221 0
Participant self-reported level of event distress
Timepoint [2] 345221 0
Prior to cannulation and immediately after cannulation
Primary outcome [3] 345222 0
Participant self-reported anxiety for future venipuncture/cannulation
Timepoint [3] 345222 0
After cannulation only
Secondary outcome [1] 460987 0
Participant self-reported usefulness of Buzzy device
Timepoint [1] 460987 0
After cannulation occurs
Secondary outcome [2] 460988 0
Participant self-reported willingness to utilise the Buzzy device in future
Timepoint [2] 460988 0
After cannulation occurs
Secondary outcome [3] 460989 0
Doctor-reported participant distress levels during and immediately after cannulation
Timepoint [3] 460989 0
After cannulation only
Secondary outcome [4] 460990 0
Doctor-reported ease of cannulation
Timepoint [4] 460990 0
After cannulation
Secondary outcome [5] 460991 0
Number of cannulation attempts
Timepoint [5] 460991 0
After cannulation

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Healthy volunteers
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomised by a study team member pulling a piece of paper out of a covered box
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2026
Actual
Date of last participant enrolment
Anticipated
1/10/2026
Actual
Date of last data collection
Anticipated
5/10/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 29439 0
Mount Gambier and Districts Health Service - Mount Gambier
Recruitment hospital [2] 29440 0
Millicent and District Hospital and Health Services - Millicent
Recruitment postcode(s) [1] 45759 0
5290 - Mount Gambier
Recruitment postcode(s) [2] 45760 0
5280 - Millicent

Funding & Sponsors
Funding source category [1] 321707 0
Government body
Name [1] 321707 0
Australian Teletrial Program
Country [1] 321707 0
Australia
Primary sponsor type
Government body
Name
Limestone Coast Local Health Network
Address
Country
Australia
Secondary sponsor category [1] 324535 0
None
Name [1] 324535 0
Address [1] 324535 0
Country [1] 324535 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320239 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 320239 0
Ethics committee country [1] 320239 0
Australia
Date submitted for ethics approval [1] 320239 0
21/06/2025
Approval date [1] 320239 0
20/10/2025
Ethics approval number [1] 320239 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149858 0
Dr Cassandra Holt
Address 149858 0
Mount Gambier and District Health Service, 276/300 Wehl St N, Mount Gambier, SA 5290
Country 149858 0
Australia
Phone 149858 0
+61 8 8721 1200
Fax 149858 0
Email 149858 0
[email protected]
Contact person for public queries
Name 149859 0
Jane Fuller
Address 149859 0
Mount Gambier and District Health Service, 276/300 Wehl St N, Mount Gambier, SA 5290
Country 149859 0
Australia
Phone 149859 0
+61 481 068 116
Fax 149859 0
Email 149859 0
[email protected]
Contact person for scientific queries
Name 149860 0
Jane Fuller
Address 149860 0
Mount Gambier and District Health Service, 276/300 Wehl St N, Mount Gambier, SA 5290
Country 149860 0
Australia
Phone 149860 0
+61 481 068 116
Fax 149860 0
Email 149860 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.