None listed
Conditions
Brief summary
A common complication in whole blood donation is a vasovagal reaction (VVR), being 90% of all incidence reports. A VVR causes a donor to feel light-headed, dizzy or faint during or after their donation. These reactions can be triggered by pain or emotions (e.g., fear of needles), or when standing up too quickly after donation. These reactions have a negative impact on donation satisfaction, donor safety and wellbeing, and donor return rates. VVRs pose a particularly high risk to first-time donors, those aged less than 30 years, females, individuals with a low body weight, and donors who report high pre-donation anxiety. In 2016 in Australia, 58% of whole blood donors did not return to donate within six months following a phlebotomist-registered reaction compared to 35% who had an uncomplicated first donation. Therefore, reducing risks to donors is inherently important. A technique which has received increasing support in reducing the rate of VVRs is applied muscle tension (AMT). AMT has been indicated to benefit the donor both physiologically, through an immediate increase in blood pressure, and psychologically, through distraction and anxiety reduction. At the Australian Red Cross Blood Service, AMT is currently included in the standard operating procedures to treat VVR but international studies have demonstrated the potential of utilising the technique as a prevention method. Practicing AMT during the entire donation procedure results in significantly fewer self-reported VVRs, increased completed donations, less chair reclining, reduced feelings of anxiety and greater intentions to return. However, these studies have reported low adherence to the technique among donors: only 22% of study participants reported using AMT throughout their donation. Despite growing evidence of the efficacy of AMT in reducing VVR, no research has examined how AMT can be successfully implemented into the routine blood donation procedure and maximise donor adherence. Consequently, the impact of AMT in day to day practice has not been examined and its potential to increase donor retention and contribute to the maintenance of a stable blood supply has yet to be fully realised. The overall aim of this project is to examine the effectiveness of AMT within Australian donor centres in a randomised controlled trial.
Interventions
This study will investigate the effectiveness of applied muscle tension (AMT) exercises in preventing vasovagal symptoms in whole blood donation through the involvement of donor centre staff. Donors will be asked by donor centre staff to use AMT in 10-second cycles: crossing their legs at the ankles, tensing their inner thigh and abdominal muscles for 5 seconds, and then relaxing for 5 seconds.
This is an open-label, three-arm, randomised, controlled, multicentre trial. Using sequentially numb
This study will investigate the effectiveness of applied muscle tension (AMT) exercises in preventing vasovagal symptoms in whole blood donation through the involvement of donor centre staff. Donors will be asked by donor centre staff to use AMT in 10-second cycles: crossing their legs at the ankles, tensing their inner thigh and abdominal muscles for 5 seconds, and then relaxing for 5 seconds. This is an open-label, three-arm, randomised, controlled, multicentre trial. Using sequentially numbered, opaque sealed envelopes, whole blood donors aged between 18 and 80 years will be randomly allocated to one of three study conditions: 1) AMT during the entire donation – donors assigned to this study condition will be instructed to practice AMT from needle insertion until they leave the donation couch. The duration of the exercises will be dependent on the duration of the donation (average donation time is 8 minutes plus 5 minutes recovering on the donation couch). All donors will receive an instruction card and collection staff will provide prompts during the donation to ensure donor adherence. 2) AMT at key time points – donors assigned to this study condition will be instructed to practice 5 cycles of AMT, then switch legs and repeat 5 cycles at three high risk time points: starting AMT just before needle insertion, just before needle removal, and just before leaving donation couch. The duration of AMT at each time point will be approximately 100 seconds (10 cycles). All donors will receive an instruction card and collection staff will provide a prompt to the donor at each time point. 3) Business as usual – donors assigned to this condition will undergo their donation as per usual and no instructions will be provided regarding AMT. Collection staff will not provide any additional prompts. At the end of the donation, the donor will be asked to complete a questionnaire to assess use of AMT and self-reported vasovagal symptoms.
Sponsors
Australian Red Cross Blood Service
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria: 1) Adults, greater than or equal to 18 years and less than 81 years 2) Less than 10 prior donations 3) Generally eligible for blood donation as per the current Guidelines for the Selection of Blood Donors (GSBD) 4) Willing and able to provide written informed consent 5) Has a whole blood donation appointment
Exclusion criteria
Exclusion criteria: 1) Not eligible to donate whole blood as per current Guidelines for the Selection of Blood Donors (GSBD) 2) Participation in an Australian Red Cross Blood Service study in the last 6 months 3) Donor with an immobilisation, even partial, of a lower limb 4) Donors who have been converted to an apheresis donation on the day
Outcome results
None listed