None listed
Conditions
Brief summary
International and Australian research has primarily focused on reducing the risk of syncope (fainting) and presyncopal symptoms ( e.g: lightheadedness, dizziness, weakness, nausea) in whole blood (WB) donors. One of the most effective strategies is to instruct donors to use lower body muscle tensing exercises at strategic time points during their donation to increase blood pressure and to distract donors from potential fainting triggers. To our knowledge, few studies have focused on reducing the risk of fainting in plasma donors. This is especially concerning as the number of faints and pre faints in plasma donors have increased in the last few years due to the increased number of plasma collections and the policy introduced in December 2017 in Australia allowing new donors to go direct to plasma. In 2018, over 8,500 donors experienced a a faint or prefaint while giving plasma in Australia, with the majority occurring in relatively inexperienced donors. In this trial, we will evaluate the effectiveness of using applied muscle tension (AMT) during a plasma donation in reducing faint and pre-faint symptoms. This study will use a pragmatic type II effectiveness-implementation hybrid (HEI) design. This allows for simultaneous testing of the effectiveness of AMT in reducing faint an pre-faints and to examine organisational perceptions that may increase adoption, implementation and sustainability of AMT in a blood donation setting. By combining the efficacy and effectiveness stages of intervention development, we can ensure more rapid translational gains (i.e. reduction in fainting/ pre-faints) while gathering information regarding the effectiveness of AMT. Aim 1 - Effectiveness: To determine whether the AMT intervention compared to a business as usual care condition reduces phlebotomist-registered pre-faint and fainting reactions among plasma donors. Aim 2 - Implementation: To develop strategies to facilitate the implementation and sustainability of AMT in plasma donations at 15 donor centres.
Interventions
Intervention: Applied Muscle Tension (AMT)
Applied Muscle Tension is a behaviour therapy technique, which has been found to increase cerebral blood flow and blood pressure (BP). The technique involves tensing and relaxing the large muscles (hamstrings, abdominal muscles) in the body
15 Australian Blood Donor Centres will be randomised in a step wedged fashion to commence a phased roll out of AMT during all eligible plasma donations at 2 weekly intervals, over a period of approximately 30 week
Intervention: Applied Muscle Tension (AMT) Applied Muscle Tension is a behaviour therapy technique, which has been found to increase cerebral blood flow and blood pressure (BP). The technique involves tensing and relaxing the large muscles (hamstrings, abdominal muscles) in the body 15 Australian Blood Donor Centres will be randomised in a step wedged fashion to commence a phased roll out of AMT during all eligible plasma donations at 2 weekly intervals, over a period of approximately 30 weeks. Donors donating during the in the intervention phases will be instructed using written materials and face to face instruction from donor centre staff to: 1) cross their legs, 2) squeeze their inner thigh and abdominal muscles, and 3) stretch their ankles. They will be asked to hold this position for 5 seconds, then relax for 5 seconds, repeating the cycle 5 times, and then switch legs. The average plasma donation time is 45minutes. All intervention phase donors will be instructed to perform AMT at different time points during the plasma donation (Needle In, 15min & 30min after donation starts, Needle out and before getting off the donor chair). Compliance to AMT will be by direct observation by Donor Centre staff and a post donation donor survey.
Sponsors
Australian Red Cross Lifeblood
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
CLUSTERS 1. Donor centres with minimum attendance of 54 plasma donors per week 2. Donor centres using the Aurora machine used as standard plasmapheresis practice for a minimum of 4 weeks to 3 months depending on guidance from the Clinical Hypervigilance team and the Donor Services Leadership Team PARTCIPANTS 1. Eligible for plasma donation as per the current ‘Guidelines for the Selection of Blood Donors’ (GSBD) 2. Plasmapheresis donation 3. Consent to participate in study (survey component only)
Exclusion criteria
CLUSTERS 1. Plasma only donor centres 2. Donor mobile units (DMUs) and demountable mobile units 3. Participation in another research study (R&D or Marketing) that may interfere with donor recruitment and the outcomes under investigation 4. Donor Services Leadership Team consider the donor centre not appropriate for participation (e.g. centre undergoing renovations, relocation) PARTICIPANTS 1. Donors not donating plasma by apheresis (e.g., whole blood, platelets, sample only) 2. Australian Red Cross Lifeblood staff members
Outcome results
None listed