Feasibility and Efficacy of using a non-invasive pain numbing device in Australian Blood Donor Centres - Part 1
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
Australian Red Cross Blood Service
50 participants
Jul 13, 2017
Interventional
Conditions
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.
Eligibility
Inclusion Criteria11
- Participant (Staff member)
- Experienced phlebotomist
- Full time or available when trial is being conducted for training and recruitment
- Consents to participation in study
- Participant (Donor)
- 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
Exclusion Criteria5
- 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
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Interventions
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.
Locations(1)
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ACTRN12617000950369