None listed
Conditions
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. We propose that a pain numbing device called “CoolSense(R)" could be effectively used by the Blood Service to reduce pain and anxiety, and enhance donor satisfaction and retention. CoolSense(R) is a hand-held non- invasive skin numbing applicator that is used to anaesthetise the skin before a painful procedure, without the use of chemicals. With an operating temperature of minus two to minus six degrees Celsius, CoolSense(R) is more effective than ice in numbing pain. In order to use CoolSense(R) in phlebotomy, the applicator must be applied to the skin after disinfection as the site would not remain desensitized for a sufficient period if applied prior to disinfection. Given that this post-disinfection application contravenes current Blood Service protocols, the objective of the bacterial load study is to assess whether the phlebotomy site remains free from microbiological contaminates after application of CoolSense(R)
Interventions
The study will assess the impact a non-invasive pain numbing device - Coolsense(R) has on the skin surface bacterial load collected from a blood donor's cubital fossa after routine disinfection of the area with BD Persist Plus on their non phlebotomy arm.
Coolsense (R) is a topical anaesthetic device that numbs the skin prior to injection. The device consists of an applicator, which has an in-built temperature gauge, as well as an antiseptic component to clean the applicator. The device is appl
The study will assess the impact a non-invasive pain numbing device - Coolsense(R) has on the skin surface bacterial load collected from a blood donor's cubital fossa after routine disinfection of the area with BD Persist Plus on their non phlebotomy arm. Coolsense (R) is a topical anaesthetic device that numbs the skin prior to injection. The device consists of an applicator, which has an in-built temperature gauge, as well as an antiseptic component to clean the applicator. The device is applied to the skin for 10 seconds to numb the phlebotomy site BD Persist Plus contains 1% Chlorhexidine Gluconate with 75% Ethanol that is applied with a single use applicator. Each donor will have their non phlebotomy cubital fossa disinfected with BD Persist Plus which is as per The Blood Services standard practice. After the Persist Plus has dried a skin swab will be taken before and after the application of the Coolsense(R) Device which for the purposes of this study only has been kept at room temperature. The tip of the device will have a small quantity, approximately 5 cent piece size of 70% Alcohol gel applied prior to contact with the skin. The gel will be allowed to dry prior to the 2nd arm swab being taken.
Sponsors
Australian Red Cross Blood Service
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adults greater than or equal to 18 years and less than 80 years 2. Eligible for blood donation as per the current ‘Guidelines for the Selection of Blood Donors’ (GSBD) 3. At least 2 previous successful donations (Plasma, Platelet or Whole Blood) 4. Able and Willing to provide written informed consen
Exclusion criteria
1. Does not meet current ‘Guidelines for the Selection of Blood Donors’ (GSBD) 2. Known sensitivity to Isopropyl Alcohol and or other topical disinfectants
Outcome results
None listed