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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]

None

Universal Trial Number (UTN)

U1111-1198-4018

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 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]

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]

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]

Staff assessments will be performed between 1 to 3 months from the end of recruitment

Secondary outcome [1]

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]

immediately before and immediately after whole blood donation

Secondary outcome [2]

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]

Immediately after whole blood donation

Secondary outcome [3]

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]

Immediately after whole blood donation

Secondary outcome [4]

Participant Reported Outcome 4
Any skin reactions to the donation reported by the donor.

Timepoint [4]

Immediately after whole blood donation and 24 after

Secondary outcome [5]

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]

Immediately after whole blood donation and within 24 hours of donation

Secondary outcome [6]

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]

Immediately after whole blood donation and within 24 hours of donation

Secondary outcome [7]

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]

Two weeks prior to donation and day of donation

Secondary outcome [8]

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]

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

Accrual to date

Final

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

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]

03/11/2016

Approval date [1]

05/01/2017

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. 

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

Dr 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

tdavison@redcrossblood.org.au

Contact person for public queries

Name

Kyle Jensen

Address

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

Country

Australia

Phone

+61 3 9863 2885

Fax

KJensen@redcrossblood.org.au

Contact person for scientific queries

Name

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

tdavison@redcrossblood.org.au

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

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