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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Blood Donation

Condition category

Condition code

Anaesthesiology

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]

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]

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]

5-10 min following blood donation

Secondary outcome [1]

Difference between intervention groups (CoolSense® or standard care) in retention at 6 months

Timepoint [1]

6 months after Baseline donation

Secondary outcome [2]

Difference between intervention groups in time to return to next donation

Timepoint [2]

6 months after Baseline donation

Secondary outcome [3]

Difference between intervention and control groups in total blood volume (TBV)

Timepoint [3]

Immediately following blood donation

Secondary outcome [4]

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]

Immediately following blood donation

Secondary outcome [5]

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]

5-10 min following blood donation

Secondary outcome [6]

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]

Pre- donation anxiety score 15-30 min prior to blood donation and post donation score 5-10 following blood donation

Secondary outcome [7]

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]

15-30 min prior to blood donation

Secondary outcome [8]

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]

15-30 min prior to blood donation

Secondary outcome [9]

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]

Within 24 hours of baseline donation

Secondary outcome [10]

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]

Within 24 hours of baseline donation

Secondary outcome [11]

Difference between intervention groups in Blood Donor Reaction Inventory (BDRI) score

Timepoint [11]

5-10 min following blood donation

Secondary outcome [12]

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]

Within 24 hours of baseline donation

Secondary outcome [13]

Percentage of participants who discontinue use of device for any reason.

Timepoint [13]

During blood donation

Secondary outcome [14]

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]

5-10 min following blood donation

Secondary outcome [15]

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]

6 months post baseline donation

Secondary outcome [16]

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]

5-10 min following blood donation

Secondary outcome [17]

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]

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]

Charities/Societies/Foundations

Name [1]

Australian Red Cross Blood Service

Address [1]

National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Red Cross Blood Service Human Research Ethics Committee

Ethics committee address [1]

C/- Sydney Processing Centre
17 O'Riordan St
Alexandria NSW 2015

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/12/2017

Ethics approval number [1]

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

Ms Tanya Davison

Address

Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9863 1600

Fax

[email protected]

Contact person for public queries

Name

Sarah Kruse

Address

Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9863 2866

Fax

[email protected]

Contact person for scientific queries

Name

Carley Gemelli

Address

Australian Red Cross Blood Service
National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004

Country

Australia

Phone

+61 3 9863 1619

Fax

[email protected]

No information has been provided regarding IPD availability

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.

Trial Review

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Documents added automatically