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The prevention of vasovagal reactions (VVR) occurring during or after donation is a major issue for the French Blood Establishment (EFS), firstly to guarantee the safety of donors but also to retain them, as this reaction is one of the negative experiences affecting the return to donation.
The EVASION study conducted in the Auvergne Rhône-Alpes region (AURA) on 4828 donors representative of the French donor population, reported a beneficial effect of muscle contraction exercises to prevent the occurrence of VVR during donation, while hydric solutions, and even more so isotonic solutions, were likely to decrease the frequency of delayed VVR.
These preventive measures have been integrated into the internal guidelines and currently include muscular and breathing exercises and hydration. Nevertheless, the isotonic solution could not be routinely deployed for feasibility and cost reasons. A salty snack could replace the isotonic solution to produce the same effects with better feasibility and acceptability. Furthermore, a significant proportion of discomfort is psychological in origin, related to stress and anxiety which persist despite these measures, particularly in the first-time donor population.
These measures, which are mainly focused on the prevention of VVR of physiological origin, are still insufficient and can be optimized and complemented to reduce the occurrence of VVR, especially in first-time donors for whom anxiety and stress play an important role in the etiology of VVR.
Two measures could further reduce the occurrence of VVR:
Hypothesis is that the combination of a psychological and physiological strategies would allow a reduction of the occurrence of immediate and/or 48 h delayed VVR during the whole blood donation in first time donors compared to the current practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | EFS usual standard practices for the whole blood donation | |
| Test Group 1 | Experimental | A psychological strategy is added to EFS standard practices before the whole blood donation
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| Test Group 2 | Experimental | A physiological strategy is added to EFS standard practices before the whole blood donation : - Ingesting a salty snack. |
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| Test group 3 | Experimental | The both psychological and physiological strategies are added to EFS standard practices before the whole blood donation
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychological strategy | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Vasovagal reactions (VVR) | Proportion of first-time donors experiencing VVR (immediate and delayed up to 48 hours) during whole blood donation managed by both psychological and physiological strategies (group 4) compared to usual standard practices (group 1) | Day 1 = donation day ; Day 3 = 48h post donation |
| Measure | Description | Time Frame |
|---|---|---|
| VVR psychological strategy | Proportion of first-time donors experiencing VVR (immediate and delayed up to 48 hours) during whole blood donation managed by psychological strategy (group 2) compared to usual standard practices (group 1) | Day 1 = donation day ; Day 3= 48h post donation |
| VVR physiological strategy |
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Inclusion Criteria:
Non-inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brice MD POREAU | Contact | 478 656 137 | +33 | brice.poreau@efs.sante.fr |
| Julie MD-PhD HAESEBAERT | Contact | 472 115 732 | +33 | julie.haesebaert@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| French Blood Establishment (EFS) | Lyon | 69153 | France |
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| ID | Term |
|---|---|
| D019462 | Syncope, Vasovagal |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Physiological strategy | Other | - ingesting a salty snack |
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Proportion of first-time donors experiencing VVR (immediate and delayed up to 48 hours) during whole blood donation managed by physiological strategy (group 3) compared to usual standard practices (group 1) |
| Day 1 = donation day ; Day 3= 48h post donation |
| Immediate VVR | Proportion of first-time donors with immediate VVR compared between the groups | Day 1 = donation day, before leaving the centre |
| Delayed VVR | Proportion of first-time donors with delayed VVR compared between the groups | Day 3= 48h post donation |
| First-time donor adherence | Adherence of the primary donor to the study strategies and to the EFS recommendations (complete intake of salty snacks, hydration, performance of muscle and breathing exercises training, performance of muscle and breathing exercises during donation, compliance with the duration of post-donation monitoring stage). | Day 1 = donation day, before leaving the centre |
| Anxiety/fear | Assessment of the evolution of the "anxiety/fear" score between arrival and before the whole blood donation, compared between the groups. This questionnaire consists of the 6-item Blood Donor Anxiety Scale (BDAS) (5-point Likert scale) (Chell et al., 2016) and a 4-item component with a 5-point Likert scale that allows for an assessment of the 4 most common donor fears (of the needle, to see blood, to feel pain, to experience sensations of discomfort). The scoring is obtained by summing up the responses to the different items. Score is between 10 and 50, a higher score is associated to a better outcome. | Day 1 = donation day, before donation |
| Sense of control and fears | Assessment of the "sense of control and fears" score, compared between the groups. The concepts measured here are the feeling of control related to giving blood (5 items) and the feeling of control over fears (4 items) according to a 5-point Likert scale. The scoring is obtained by summing up the answers to the different items. Score is between 9 and 45, a higher score is associated to a better outcome. | Day 1 = donation day, before donation |
| Feelings of discomfort | Assessment of the "feelings of discomfort" score, compared between the groups. The BDRI (Blood Donation Reactions Inventory) (France et al., 2008) provides an assessment of the subjective evaluation of 11 pre-syncopal symptoms (5-point Likert scale). The BDRI is easily understood by donors and is rapid. The BDRI provides important information about the donor experience to predict satisfaction and likelihood of re-donation. The score is calculated by summing up the responses to the various items. Score is between 11 and 55, a higher score is associated to a worse outcome. | Day 1 = donation day, after donation and before leaving the centre |
| First-time donor retention | Compared between the groups the number of first-time donors who made a second blood donation in the 12 months following the first-time donation, collected by query from the EFS computerized file | Month 12 following the first-time donation |
| D013575 | Syncope |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |