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Trial registered on ANZCTR


Registration number
ACTRN12617000950369
Ethics application status
Approved
Date submitted
27/06/2017
Date registered
3/07/2017
Date last updated
29/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and Efficacy of using a non-invasive pain numbing device in Australian Blood Donor Centres - Part 1
Scientific title
An investigator initiated, prospective, non-randomised study to assess the feasibility and efficacy of using the pain numbing device Coolsense (R) on pain and anxiety in Australian adult Blood Donors
Secondary ID [1] 291875 0
None
Universal Trial Number (UTN)
U1111-1198-4018
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Donation 303166 0
Condition category
Condition code
Anaesthesiology 302609 302609 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of the study is to assess the feasibility of using a pain numbing device or injection site desensitiser for venepuncture performed in Australian Blood Donor centers for whole blood collections.

The Intervention to be evaluated is a Class 1 Medical Device, Coolsense(R), registered with the TGA as an Injection Site Desensitizer and listed on the Australian Register of Therapeutic Goods (ARTG) No. 213960. It is commercially available in Australia through the local supplier Balance Medical Pty Ltd. The Coolsense(R) device is a small handheld anesthetic device, comprised of an approx. 2 cm diameter metal (aluminium) pin that is covered with a alcoholic gel filled lid. The lid is designed to dispense a small amount of gel on to the metal pin via a small sponge housed in the lid when the centre of the lid is pressed.

The device is placed in a domestic freezer (approx. - 18 degrees) for a minimum of 2 hours prior to first use. There is a button on the side of the device that when pressed will illuminate either, Red, Green or Blue. If the light is red the device has not cooled sufficiently and if it is blue it needs to be taken out of the freezer and warmed slightly until the light is green. Green indicates the device is at the appropriate temperature to use. After the device has been removed from the freezer and light is green the centre of the lid is pressed to release a small amount of alcoholic gel to coat the cooled metal pin the lid is then removed. The device is now primed for use and ready to be placed on the area of the body to be anaesthetised.

For this study on selected days at 2 participating donor centres all eligible whole blood donors will be approached to participate in the study. Donors will initially be approached before the blood donation eligibility interview and given a copy of the Participant Information Sheet to read while they are waiting for their interview. Potential participants will be given the opportunity to ask any questions they may have about the study and if they consent they will be asked to sign the informed consent form. Potential participants will then be asked to complete a short pre-donation questionnaire, then proceed to the interview room. During the pre-donation interview, potential participants will have their veins assessed by a donor centre staff member, and those who are still eligible to donate and who have suitable veins will proceed to the collections area to participate in a Coolsense(R) assisted phlebotomy.

A donor centre phlebotomist will remove the Coolsense(R) device from the freezer and prime it ready for use. All consented donors will have their cubital fossa of their donation arm disinfected by the phlebotomist as per Blood Service standard operating procedures. The Coolsense(R) device will then be applied to the phlebotomy site for maximum 10 seconds by the staff member performing the phlebotomy. After cooling of the site, the blood collection procedure will proceed immediately or no longer than 5 seconds after removing the device from the phlebotomy site.
Intervention code [1] 297994 0
Treatment: Devices
Comparator / control treatment
An active control or standard of care comparator will be only used for evaluating the impact of using the device has on the operational 'work flow' at the donor centre. The following measures will be compared between standard workflow activities and workflow activities when the study device is being used.
1. Time from donor arriving to phlebotomy or needle in
2 Staff distance travelled on the donor centre floor
Control group
Active

Outcomes
Primary outcome [1] 302575 0
The primary outcome will be staff acceptability of using the Coolsense(R) device in the blood donation setting. This will be determined by items on a staff questionnaire that has been specifically designed for the study and discussion items in a focus group held at each participating donor centre. These items relate to any identified problems in using Coolsense(R), perceptions of ease of use and impact on the donation time, and views on the routine use of Coolsense(R), as well as their views on whether use of the device impacted on the donation experience for donors.
Timepoint [1] 302575 0
Staff assessments will be performed between 1 to 3 months from the end of recruitment
Secondary outcome [1] 336400 0
Participant Reported Outcomes
Whether the pain the donor reports after the administration of the Coolsense® device is lower than their level of anticipated pain reported prior to cannulation. Pre- and post-donation pain ratings are made on a single item, scored from 1 = no pain sensation to 10 = worst pain imaginable.
Timepoint [1] 336400 0
immediately before and immediately after whole blood donation
Secondary outcome [2] 336498 0
Participant reported outcome 2
Whether the anxiety reported post-donation is lower than the anxiety reported pre-donation, as measured on the 6-item Blood Donation Anxiety Scale a tested shortened version of the validated .
Timepoint [2] 336498 0
Immediately after whole blood donation
Secondary outcome [3] 336499 0
Participant reported outcome 3
Whether the donor intends to donate again in the next 6 months, using a three item scale from the validated 'theory of planned behaviour scale testing intention' from France et al., scored from 1 = strongly disagree to 7 = strongly agree.
Timepoint [3] 336499 0
Immediately after whole blood donation
Secondary outcome [4] 336500 0
Participant Reported Outcome 4
Any skin reactions to the donation reported by the donor.
Timepoint [4] 336500 0
Immediately after whole blood donation and 24 after
Secondary outcome [5] 336505 0
Clinical and Safety Outcome 1
whether the use of the Coolsense® device causes vasoconstriction, and impacts on the volume of blood collected and the time required for the phlebotomy procedure.
Timepoint [5] 336505 0
Immediately after whole blood donation and within 24 hours of donation
Secondary outcome [6] 336506 0
Clinical and Safety Outcome 2
The number of localised adverse reactions associated with the use of the Coolsense® device. Staff will report the following skin reactions: (i) skin blanching, (ii) skin redness, (iii) burning, and (iv) skin irritation, rated as none, mild, moderate, or severe for each donor.
Timepoint [6] 336506 0
Immediately after whole blood donation and within 24 hours of donation
Secondary outcome [7] 336507 0
Workflow Outcome 1
Impact on donor time: The time taken from the donor arriving at the donor centre to starting the phlebotomy (‘needle in’) will be recorded, and compared to non- Coolsense® whole blood donation times each day. In addition, the average time for days where the trial is operational will compared to the same week days two weeks earlier.
Timepoint [7] 336507 0
Two weeks prior to donation and day of donation
Secondary outcome [8] 336516 0
Workflow Outcome 2
Impact on staff movements: The movement of phlebotomists in administering Coolsense® will be tracked (distance travelled) and compared with non- Coolsense® assisted donations conducted during the trial period.
Timepoint [8] 336516 0
From the time donor checks in at reception to the time the donor leaves the refreshment area

Eligibility
Key inclusion criteria
Participant (Staff member)
Inclusion Criteria
• Experienced phlebotomist
• Full time or available when trial is being conducted for training and recruitment
• Consents to participation in study

Participant (Donor)
Inclusion Criteria
• Adults greater than 18 years of age and less than 80 years of age
• Presenting at a participating donor centre for a whole blood donation during the trial period.
• Eligible for a whole blood donation as per the current ‘Guidelines for the Selection of Blood Donors’ (GSBD)
• Willing and able to provide written informed consent
• At least 2 previous successful donations (Plasma, Platelet or Whole Blood) in the last 2 years
• Veins that are visible, palpable, or can be palpated under pressure (using a blood pressure cuff) when assessed
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria
• Known sensitivity to Isopropyl Alcohol and or other topical disinfectants
• Documented history of a Donor Adverse Event-localised event e.g. haematoma
• Donors who experienced a vasovagal reaction on their last donation that is documented, or self-reported on returned donation
• Donor records from a previous donation indicate unsuitable veins, as recorded by collections staff.
• Currently or has been enrolled in a Blood Service research study within the last 6 months

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/07/2017
Actual
13/07/2017
Date of last participant enrolment
Anticipated
Actual
19/09/2017
Date of last data collection
Anticipated
Actual
19/09/2017
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 296376 0
Charities/Societies/Foundations
Name [1] 296376 0
Australian Red Cross Blood Service
Country [1] 296376 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Red Cross Blood Service
Address
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 295321 0
None
Name [1] 295321 0
Address [1] 295321 0
Country [1] 295321 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297613 0
Australian Red Cross Blood Service
Ethics committee address [1] 297613 0
C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Ethics committee country [1] 297613 0
Australia
Date submitted for ethics approval [1] 297613 0
03/11/2016
Approval date [1] 297613 0
05/01/2017
Ethics approval number [1] 297613 0
2016#27

Summary
Brief summary
A significant barrier to donation and donor retention is fear of needle pain, pain actually experienced during phlebotomy, and associated anxiety. It is clear from previous research that anticipatory anxiety and/or fear of needle pain does not dissuade all prospective donors, however these inter-related barriers have negative consequences for donor retention. Donors reporting higher levels of anxiety and fear of needle pain are more likely to experience a vasovagal reaction, including full faint and/or presyncopal symptoms such as faintness, dizziness, and light-headedness. A recent study by France et al (2012) found that fear of injections and blood draws had the strongest relationship to post-donation Blood Donor Reaction Inventory (BDRI) scores, a self-rated measure of presyncopal reactions to blood donation. A particularly strong relationship between fear related to blood donation and adverse events was noted for female, first time donors. The findings of this study are consistent with other research showing that pre- donation fear, as measured by a single question about fear of needles, was positively related to post- donation BDRI scores and inversely related to ratings of likelihood of future donation, as well as actual rates of return in the subsequent year 7. Interestingly, this effect appears to be dependent on actual reaction occurrence, suggesting opportunities to intervene to reduce fear, anxiety, and adverse reactions are critical to improving retention. In addition, it is well-documented that donor adverse events with or without self-report of fear/anxiety are related to future intention to donate and are an independent predictor of retention, particularly for first time donors. For example, France, Radar, & Carlson (2005) reported, in a 1-year prospective study of nearly 90,000 blood donors, return rates of 64% for individuals without an adverse reaction, in comparison with just 40% for those who did experience a reaction.

Although there are few studies examining pain and donor behaviour, there is evidence that blood donors who report lower levels of needle pain are typically less anxious, and lower needle pain ratings have been associated with greater donation satisfaction, which is in turn related to intention to return to donate. Taken together the research to date suggests that provision of methods that reduce or even eliminate pain and/or reduce anxiety and fear are likely to enhance the safety and comfort of blood donors and improve retention.

The primary aim of the feasibility trial is to assess the feasibility and acceptability of the Coolsense(R) device in a donor centre environment from the perspective of staff and donors whilst evaluating any clinical and potential safety events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74590 0
Dr Tanya Davison
Address 74590 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 74590 0
Australia
Phone 74590 0
+61 3 9863 1600
Fax 74590 0
Email 74590 0
[email protected]
Contact person for public queries
Name 74591 0
Kyle Jensen
Address 74591 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 74591 0
Australia
Phone 74591 0
+61 3 9863 2885
Fax 74591 0
Email 74591 0
[email protected]
Contact person for scientific queries
Name 74592 0
Tanya Davison
Address 74592 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 74592 0
Australia
Phone 74592 0
+61 3 9863 1600
Fax 74592 0
Email 74592 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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