Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000099224
Ethics application status
Approved
Date submitted
28/12/2017
Date registered
23/01/2018
Date last updated
11/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a non-invasive injection site desensitiser device for use in blood donation. Part 2: Efficacy
Scientific title
An investigator initiated, prospective, randomised controlled trial to assess the efficacy of using the injection site desensitiser device Coolsense (R) on pain and anxiety in Australian adult Blood Donors - Part 2
Secondary ID [1] 293663 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Donation 305954 0
Condition category
Condition code
Anaesthesiology 305151 305151 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Participants will then be randomised to standard phlebotomy (active control) or coolsense(R) (intervention) assisted phlebotomy. All participants will 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 undergo standard phlebotomy or a Coolsense(R) assisted phlebotomy.

All consented donors will have their cubital fossa of their donation arm disinfected with ChloroPrep(R) - skin prep BD or approved alternative for donors who may have had previous localised reactions to the ChloroPrep(R) by the phlebotomist as per Blood Service standard operating procedures. For donors randomised to standard of care, phlebotomy will proceed as per existing practices.

For donors randomised to the Coolsense(R) device, the donor centre's phlebotomist will remove the Coolsense(R) device from the freezer and prime it ready for use. The device will then be applied to the phlebotomy site for minimum of 10 seconds to maximum 30 seconds by the staff member performing the phlebotomy. The optimal safe application time was determined during the feasibility study (publication pending) and recommendations from the manufacturer.. 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] 299932 0
Treatment: Devices
Comparator / control treatment
The active control for this study is standard of care phlebotomy with out any form of anesthetic. As with the intervention arm, donors will have their arm disinfected, and then needle will be inserted in to the centre of the selected vein after the disinfectant dries. The phlebotomy/ collection procedures for whole blood should take less than 15-20 minutes, after which time the needle will be removed and site will be have pressure and a bandage applied
Control group
Active

Outcomes
Primary outcome [1] 304327 0
The difference between intervention groups (CoolSense® or standard care) in pain experienced by whole blood donors during needle insertion. Pain is assessed using a 10-point Likert scale from 1 = no pain sensation to 10 = worst pain imaginable.
Timepoint [1] 304327 0
5-10 min following blood donation
Secondary outcome [1] 341588 0
Difference between intervention groups (CoolSense® or standard care) in retention at 6 months
Timepoint [1] 341588 0
6 months after Baseline donation
Secondary outcome [2] 341589 0
Difference between intervention groups in time to return to next donation
Timepoint [2] 341589 0
6 months after Baseline donation
Secondary outcome [3] 341590 0
Difference between intervention and control groups in total blood volume (TBV)
Timepoint [3] 341590 0
Immediately following blood donation
Secondary outcome [4] 341591 0
Difference between intervention and control groups in number of successful donations (optimum collection pack volume reached 450-470 ml within target timeframe of 12 minutes)
Timepoint [4] 341591 0
Immediately following blood donation
Secondary outcome [5] 341592 0
Difference between intervention groups in satisfaction is assessed using study specific 10-point Likert scale from 1 = not at all satisfied to 10 = extremely satisfied.
Timepoint [5] 341592 0
5-10 min following blood donation
Secondary outcome [6] 341593 0
Difference between intervention groups in pre & post-donation anxiety score. An established 6-item Blood Donation Anxiety Scale will be used to measure pre and post donation anxiety
Timepoint [6] 341593 0
Pre- donation anxiety score 15-30 min prior to blood donation and post donation score 5-10 following blood donation
Secondary outcome [7] 341594 0
Difference between intervention groups in anticipated pain. Anticipated pain is assessed pre-donation using a 10-point Likert scale from 1 = no pain sensation to 10 = worst pain imaginable.
Timepoint [7] 341594 0
15-30 min prior to blood donation
Secondary outcome [8] 341595 0
Difference between intervention groups in pre-donation fear. Fear regarding blood draw is assessed using a 5-point Likert scale from 1 = Not at all afraid to 5 = extremely afraid.
Timepoint [8] 341595 0
15-30 min prior to blood donation
Secondary outcome [9] 341596 0
Difference between intervention groups in vasovagal reactions. Blood Service staff will assess any physical symptoms a donor may experience during donation as per standard operating procedures
Timepoint [9] 341596 0
Within 24 hours of baseline donation
Secondary outcome [10] 341597 0
Difference between intervention groups in all other adverse effects. For example: phlebotomy injury or vaso vagal reactions. Adverse donation effects will be assessed using blood service standard operating procedures
Timepoint [10] 341597 0
Within 24 hours of baseline donation
Secondary outcome [11] 341598 0
Difference between intervention groups in Blood Donor Reaction Inventory (BDRI) score
Timepoint [11] 341598 0
5-10 min following blood donation
Secondary outcome [12] 341599 0
Percentage of participants with potential device-related side-effects (skin: redness, blanching, irritation, itching, rash, burning). Donor centre nurses will inspect phlebotomy site for localised reactions after the coolsense device is applied until the donor is moved to the refreshment area. Donors may then report by phone any delayed reactions via the Blood Service national contact centre
Timepoint [12] 341599 0
Within 24 hours of baseline donation
Secondary outcome [13] 341600 0
Percentage of participants who discontinue use of device for any reason.
Timepoint [13] 341600 0
During blood donation
Secondary outcome [14] 341601 0
Percentage of donors who were satisfied with the outcome from using the device. The donor acceptability questionnaire is comprised of 13 open and closed questions that use Likert- type scales.

The Questionnaire designed specifically for this study is divided in to questions on:
a) how a donor feels pre donation;
b) how a donor feels post donation;
c) how a donor feels about donating again in the future, and
d) donor perceptions of a CoolSense®-assisted phlebotomy.
Timepoint [14] 341601 0
5-10 min following blood donation
Secondary outcome [15] 341602 0
Percentage of staff with positive views on the use of Coolsense for phlebotomies. The staff acceptability questionnaire designed specifically for the study is comprised of 10 open and closed questions that use Likert-type scales.
Timepoint [15] 341602 0
6 months post baseline donation
Secondary outcome [16] 342001 0
Difference between intervention groups on intention to donate use a three item scale from France et al. Theory of Planned Behavior constructs in Blood Donation
Timepoint [16] 342001 0
5-10 min following blood donation
Secondary outcome [17] 342002 0
Difference between intervention groups in experienced pain. Experienced pain is assessed post-donation using a 10-point Likert scale from 1 = no pain sensation to 10 = worst pain imaginable.
Timepoint [17] 342002 0
5-10 min following blood donation

Eligibility
Key inclusion criteria
Participants (Donors)
Inclusion Criteria
• New or experienced whole blood donor
• New donors aged between 18 and 70 years of age OR experienced donors aged between 18 and 80 years of age
• Whole Blood appointment at a participating donor centre
• 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

Participants (Staff)
Inclusion Criteria
• Qualified Blood Service phlebotomist
• Willing and able to provide written informed consent
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 or other topical disinfectants
• Donor reports a known sensitivity to cool stimuli (e.g. Raynaud’s phenomenon, Wilsons Syndrome)
• Donors eligible for sample only collections (sample only appointments or identified as sample only candidate during interview e.g: Low Hb donors for ferritin testing)
• Donors undergoing apheresis collections
• Phlebotomist’s perception that the donor’s veins are unsuitable for application of a cooling device (e.g., requires the application of a heat pack for phlebotomy)
• Current enrolment or previous enrolment in a Blood Service research study within the last 6 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
Actual
4/01/2018
Date of last participant enrolment
Anticipated
4/06/2018
Actual
16/02/2018
Date of last data collection
Anticipated
4/12/2018
Actual
Sample size
Target
450
Accrual to date
Final
174
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 298283 0
Charities/Societies/Foundations
Name [1] 298283 0
Australian Red Cross Blood Service
Country [1] 298283 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] 297399 0
None
Name [1] 297399 0
Address [1] 297399 0
Country [1] 297399 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299283 0
Australian Red Cross Blood Service Human Research Ethics Committee
Ethics committee address [1] 299283 0
C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015
Ethics committee country [1] 299283 0
Australia
Date submitted for ethics approval [1] 299283 0
Approval date [1] 299283 0
04/12/2017
Ethics approval number [1] 299283 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.

Recently a small study (publication pending) was conducted to assess the feasibility of using the Coolsense(R) device in a blood donation setting and results showed that it was generally well tolerated and accepted by donors and staff. Therefore the aim of the this next trial is to assess the efficacy of the Coolsense(R) device in reducing the pain experienced by whole blood donors during phlebotomy
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79902 0
Ms Tanya Davison
Address 79902 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 79902 0
Australia
Phone 79902 0
+61 3 9863 1600
Fax 79902 0
Email 79902 0
[email protected]
Contact person for public queries
Name 79903 0
Ms Sarah Kruse
Address 79903 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 79903 0
Australia
Phone 79903 0
+61 3 9863 2866
Fax 79903 0
Email 79903 0
[email protected]
Contact person for scientific queries
Name 79904 0
Ms Carley Gemelli
Address 79904 0
Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004
Country 79904 0
Australia
Phone 79904 0
+61 3 9863 1619
Fax 79904 0
Email 79904 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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