Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001645246
Ethics application status
Approved
Date submitted
3/10/2018
Date registered
4/10/2018
Date last updated
13/06/2019
Date data sharing statement initially provided
13/06/2019
Date results information initially provided
13/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A safety and exploratory efficacy pilot study of Needlecalm™ in reducing pain and needle sensation in a venepuncture procedure: a single group, single-blinded, randomised placebo-controlled investigation in healthy volunteers.
Scientific title
A safety and exploratory efficacy pilot study of NeedleCalm™ in reducing pain and needle sensation in a venepuncture procedure: a single group, single-blinded, randomised placebo-controlled investigation in healthy volunteers.
Secondary ID [1] 296240 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
iatrogenic pain associated with needle procedures 309880 0
Condition category
Condition code
Anaesthesiology 308671 308671 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Day 1 – In House

At Approximately 8 am, a study nurse will document participants’ vital signs (blood pressure, heart rate, temperature, respiration rate). Participants will be randomised to the treatment that is first administered. Subsequently, participants will be asked to sit on a chair and extend their dominant arm underneath a barrier which prevents them from watching the procedure. NeedleCalm™ or a placebo will be applied to the area where the venepuncture is to be performed. The nurse will then administer a standard venepuncture procedure on the participant’s cubital fossa and collect 5 ml of blood while another registered nurse is sitting by the participant side to monitor for adverse events. All blood samples collected from participants will be discarded and will not be used for analysis. After the procedure, the needle will be disposed of in a sharps bin and the body of the device is removed and disposed of as medical waste. The adhesive remaining on the skin includes a flap which is folded over and adheres to the injection site, replacing the need for a cotton wool ball and separate band-aid.
Immediately after the needle and the device have been removed, participants will be asked to complete the Southampton Needle Sensation Questionnaire to evaluate procedure-related needle sensation and pain. Vital signs will be measured after the completion of the questionnaire.
Four hours after the first venepuncture has been performed, the exact same procedure is to be repeated using the remaining Investigational Product. Participants vital signs will be measured before and after. Once more, participants will be asked to complete the Southampton Needle Sensation Questionnaire after the second venepuncture . Participants will be kept under observation for one hour after the second procedure has been performed for the emergence of new symptoms and will subsequently be able to leave the facility provided that there are no health and safety concerns (between approximately 1:30 and 4:30 pm).
Study Day 2 – Home

Twenty-four hours after the administration of the second intervention, study staff will contact participants via telephone to follow-up on the treatments received and ensure that there are no health and safety concerns. Therefore, participants will be closely monitored for adverse events from the signing of the informed consent until 24 hours after the administration of the second intervention.
Placebo is a standard band-aid which consists of a small gauze pad and adhesive bandage.
The Needlecalm device is applied to the skin approximately 30 seconds prior to venepuncture.
The Needlecalm device comprises of a medical grade nylon material. It is intended for use in venepuncture, Intravenous cannulation, intramuscular and sub cutaneous injections.
Intervention code [1] 312564 0
Prevention
Intervention code [2] 312580 0
Treatment: Devices
Comparator / control treatment
Placebo is a standard band-aid which consists of a small gauze pad and adhesive bandage.
It will be applied to the same area as that of the Needlecalm device: above the injection site for the same amount of time, approximately 30 seconds prior to the venepuncture.
Control group
Active

Outcomes
Primary outcome [1] 307637 0
•The primary outcome is to assess the safety of the IP by
Clinical assessments including:
1. Recorded self-reported/observed adverse events;
2. Vital signs assessment at screening and throughout the study period; pulse, blood pressure, oxygen saturations, respiration rate. Height and weight. They will be assessed using an automatic blood pressure monitor, a pulse oximeter and nurse assessment. Height and weight will be measured using scale and tape measure.

Possible adverse events include bruising, swelling, allergic reaction to device. This will be assessed and monitored by the Registered Nurse and Principal Investigator.
Timepoint [1] 307637 0
1. Throughout study period (from signing of the informed consent, up to follow up)
2. Throughout study period ( screening and throughout confinement period)
Secondary outcome [1] 352466 0

2) Needle sensation as assessed by the Southhampton Needle Sensation Questionnaire
Timepoint [1] 352466 0
1. Post procedure. Once only after each procedure.
Secondary outcome [2] 352515 0
Pain assessed by McGill questionnaire
Timepoint [2] 352515 0
1. Post procedure. Once only after each procedure.

Eligibility
Key inclusion criteria
1) Participants between 18 and 60 years of age at time of entry on study;
2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment;
3) Participants agree to undergo a venepuncture procedure once per procedure in the cubital fossa of the dominant arm and have 5 ml of blood collected; (i.e 10ml of blood will be collected).
4) Participants agree to adhere to the study protocol;
5) No history of illicit intravenous drug use;
6) No history of needle-phobia (trypanophobia);
7) No history of any chronic diseases.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including: physical examination, medical history, clinical chemistry, haematology, urinalysis, vital signs;
2) Current or previous allergies or allergic responses to latex;
3) Current use of any intravenously administered, prescribed or illicit drugs;
4) Any history of moderate to severe needle-phobia (trypanophobia);
5) Pregnant or nursing an infant;
6) Any psychiatric disorders by history or examination that would prevent completion of the venepuncture procedure or result in possible adverse events for the participant;
7) The current use of any prescribed or over the counter analgesia (7 days wash-out period required);
8) Not have received more than two needle procedures in the past 12 months.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/09/2018
Date of last participant enrolment
Anticipated
6/10/2018
Actual
6/10/2018
Date of last data collection
Anticipated
7/10/2018
Actual
7/10/2018
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300836 0
Self funded/Unfunded
Name [1] 300836 0
Lauren Barber
Country [1] 300836 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Needlecalm Pty Ltd
Address
PO Box 635 Avalon 2107 NSW
Country
Australia
Secondary sponsor category [1] 300399 0
None
Name [1] 300399 0
Address [1] 300399 0
Country [1] 300399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301605 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 301605 0
11-23 Burwood Rd Hawthorn Melbourne VIC 3122
Ethics committee country [1] 301605 0
Australia
Date submitted for ethics approval [1] 301605 0
07/08/2018
Approval date [1] 301605 0
03/09/2018
Ethics approval number [1] 301605 0
0050E_2018

Summary
Brief summary
NeedleCalm is a single-use disposable medical device to alleviate pain associated with injections and assist with the reduction of fear of injections. The NeedleCalm™ technology uses the gate control theory of pain awareness and transmission.The device will be intended for use for all blood collections, intravenous cannula insertion, IM and SC injections.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87530 0
Prof Luis Vitetta
Address 87530 0
Medlab Clinical
66 McCauley St Alexandria 2015 NSW
Country 87530 0
Australia
Phone 87530 0
+61 2 8188 0311
Fax 87530 0
Email 87530 0
[email protected]
Contact person for public queries
Name 87531 0
Ms Serena Dal Forno
Address 87531 0
Medlab

66 McCauley St Alexandria NSW 2015
Country 87531 0
Australia
Phone 87531 0
+61 2 8188 0311
Fax 87531 0
Email 87531 0
[email protected]
Contact person for scientific queries
Name 87532 0
Prof Luis Vitetta
Address 87532 0
Medlab
66 McCauley St Alexandria NSW 2015
Country 87532 0
Australia
Phone 87532 0
+61 2 8188 0311
Fax 87532 0
Email 87532 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IP reasons.


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.