Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000693628p
Ethics application status
Submitted, not yet approved
Date submitted
5/06/2023
Date registered
28/06/2023
Date last updated
28/06/2023
Date data sharing statement initially provided
28/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot trial of the efficacy of a novel medical device to alleviate pain during venepuncture.
Scientific title
A pilot trial of the efficacy of a novel medical device to alleviate pain in female adults undergoing venepuncture.
Secondary ID [1] 309842 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venepuncture pain 330274 0
Condition category
Condition code
Public Health 327140 327140 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are testing the efficacy of a novel, inexpensive, non-invasive device for the purpose of reducing pain associated with venepuncture. The device employs a detachable ‘distractor tip’ proximal to the needle tip of a phlebotomy device, wherein the distractor tip is configured to contact the tissue surface once only, lasting for a few seconds, before and during insertion of the phlebotomy needle; thereby providing a stimulant to the non-nociceptive nerve fibres and, in effect, inhibiting adjacent pain fibres. Adherence to the intervention will be directly monitored by research staff.
Intervention code [1] 326274 0
Treatment: Devices
Comparator / control treatment
The control group is represented by participants undergoing routine phlebotomy procedures, for the purpose of blood testing.
Control group
Active

Outcomes
Primary outcome [1] 335010 0
Pain during venepuncture, as assessed by a Visual Analogue Scale.
Timepoint [1] 335010 0
At the end of each venepuncture event.
Secondary outcome [1] 422706 0
The success rate of obtaining adequate blood sample at the time of venepuncture. The phlebotomist will maintain a record of his/her success rate, on each participant.
Timepoint [1] 422706 0
At the conclusion of the study.

Eligibility
Key inclusion criteria
Patients undergoing routine blood testing for the purpose of cycle tracking, at the time of fertility treatment.
Minimum age
18 Years
Maximum age
48 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who are attending phlebotomy for non cycle-tracking purposes.

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Continuous variables, such as Visual Analogue Scale (VAS) pain score, will be analysed using the Student’s t-test or analysis of variance with parametric or non-parametric tests. Categorical variables, such as the need for multiple venepuncture attempts, will be analysed using the Fisher’s exact test. Data analysis will be performed using the GraphPad Prism version 9.5.1.

Hypothesising a 20% reduction of the VAS score between the control and intervention groups, 17 patients in each arm would be required to have an 80% power to detect a significant difference using the Student’s t-test (two-sided, a=0.05). Standard deviations for both groups were assumed to be 1.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2023
Actual
Date of last participant enrolment
Anticipated
3/08/2023
Actual
Date of last data collection
Anticipated
3/08/2023
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 40523 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 314027 0
Commercial sector/Industry
Name [1] 314027 0
Prudenfort Pty Ltd
Country [1] 314027 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Prudenfort Pty Ltd
Address
1204 / 1 Adelaide Street, Bondi Junction, NSW 2022.
Country
Australia
Secondary sponsor category [1] 315918 0
None
Name [1] 315918 0
Address [1] 315918 0
Country [1] 315918 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313163 0
IVF Australia Ethics Committee
Ethics committee address [1] 313163 0
Ethics committee country [1] 313163 0
Australia
Date submitted for ethics approval [1] 313163 0
04/06/2023
Approval date [1] 313163 0
Ethics approval number [1] 313163 0

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

Contacts
Principal investigator
Name 127210 0
Dr Dave Listijono
Address 127210 0
IVF Australia Westmead
Level 2 / 20-22 Mons Road
Westmead
NSW 2145
Country 127210 0
Australia
Phone 127210 0
+61 2 8844 1550
Fax 127210 0
Email 127210 0
dave.listijono@gmail.com
Contact person for public queries
Name 127211 0
Dave Listijono
Address 127211 0
IVF Australia Westmead
Level 2 / 20-22 Mons Road
Westmead
NSW 2145
Country 127211 0
Australia
Phone 127211 0
+61 02 88441550
Fax 127211 0
Email 127211 0
dave.listijono@gmail.com
Contact person for scientific queries
Name 127212 0
Dave Listijono
Address 127212 0
IVF Australia Westmead
Level 2 / 20-22 Mons Road
Westmead
NSW 2145
Country 127212 0
Australia
Phone 127212 0
+61 02 88441550
Fax 127212 0
Email 127212 0
dave.listijono@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a pilot clinical trial of a novel medical device, designed for proof-of-concept and safety purposes.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19379Study protocol  Dave.Listijono@ivf.com.au 386038-(Uploaded-27-06-2023-21-39-38)-Study-related document.docx
19380Statistical analysis plan  Dave.Listijono@ivf.com.au 386038-(Uploaded-27-06-2023-21-39-55)-Study-related document.docx
19381Informed consent form  Dave.Listijono@ivf.com.au 386038-(Uploaded-27-06-2023-21-40-04)-Study-related document.docx



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.