Prevention of Vasovagal Reactions in First-time Blood Donors Using a Combined PSYchological and Physiological Approach

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHospices Civils de Lyon

About this trial

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:

* Reinforcement of the physiological strategy: ingestion of a salty snack before donation, the effect of which could be similar to the effect of the isotonic solution, which could not be delivered in practice because of its cost following the data of the EVASION study. * Addition of a psychological strategy: flyer given at the interview presenting the four most frequent fears as well as a description of the recommended muscular and respiratory exercises, followed by the execution of the recommended exercises before the sampling.

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

M/F between 18 and 70 years old,

A first-time donor who wishes to donate blood in Lyon, either at a fixed site or at a mobile unit,

Declared fit to donate whole blood after the EFS pre-donation interview,

Weight ≥ 50kg and height ≥ 135 cm,

Disqualifiers

Withdrawal of consent

First-time donor with anemia following routine hemoglobin testing

First-time donor not reachable for telephone interview

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychological strategy

    Other intervention

    * flyer given at the interview presenting the 4 most frequent fears as well as a description of the recommended muscular and breathing exercises, * then realization accompanied by a training of these exercises

  • Physiological strategy

    Other intervention

    \- ingesting a salty snack

Treatment groups

5,320 Participants
are divided into 4 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Test Group 1Experimental treatment 1 intervention
Group C: Test Group 2Experimental treatment 1 intervention
Group D: Test group 3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
Day 1 = donation day ; Day 3 = 48h post donation

Secondary outcomes

1

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)

Time frame
Day 1 = donation day ; Day 3= 48h post donation
2

VVR physiological strategy

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)

Time frame
Day 1 = donation day ; Day 3= 48h post donation
3

Immediate VVR

Proportion of first-time donors with immediate VVR compared between the groups

Time frame
Day 1 = donation day, before leaving the centre
4

Delayed VVR

Proportion of first-time donors with delayed VVR compared between the groups

Time frame
Day 3= 48h post donation

Other outcomes

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