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

NCT06014346 | Not Yet Recruiting DMC

• 1 other identifier: 69HCL22_0131
• Study Type: interventional
• Target: 5,320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vasovagal Reaction

Keywords

first time donor; whole blood donation; vasovagal Reaction; physiological; psychological; BDRI; BDAS

Outcome Measures

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)

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

Secondary Outcomes (9)

• VVR psychological strategy

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

• VVR physiological strategy

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

• Immediate VVR

  Day 1 = donation day, before leaving the centre

• Delayed VVR

  Day 3= 48h post donation

• First-time donor adherence

  Day 1 = donation day, before leaving the centre

Study Arms (4)

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

Other: Psychological strategy

Test Group 2

EXPERIMENTAL

A physiological strategy is added to EFS standard practices before the whole blood donation : - Ingesting a salty snack.

Other: Physiological strategy

Test group 3

EXPERIMENTAL

The both psychological and physiological strategies are added to EFS standard practices before the whole blood donation * flyer given at the interview presenting the 4 most frequent fears as well as a description of the recommended muscular and breathing exercises, * followed by a training of these exercises and their execution Ingesting a salty snack.

Other: Psychological strategy; Other: Physiological strategy

Interventions

Psychological strategy OTHER

* 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

Test Group 1; Test group 3

Physiological strategy OTHER

\- ingesting a salty snack

Test Group 2; Test group 3

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Available for telephone contact between to 5d +/- 2 days after donation,
• Having signed a written consent to participate in the study.
• Known allergy to shellfish, and/or gluten, and/or milk, and/or soy,
• Incomprehension of the French language,
• First-time donor under protective measures (guardian, curator) or any other administrative measure,
• Not affiliated to the French social security system or any other equivalent system,
• Pregnant or breastfeeding woman,
• Subject participating in any other interventional or non-interventional research

You may not qualify if:

• Withdrawal of consent
• First-time donor with anemia following routine hemoglobin testing
• First-time donor not reachable for telephone interview

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

French Blood Establishment (EFS)

Lyon, 69153, France

Location

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Brice MD POREAU

CONTACT

478 656 137; brice.poreau@efs.sante.fr

Julie MD-PhD HAESEBAERT

CONTACT

472 115 732; julie.haesebaert@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: October 10, 2023
• Primary Completion: May 18, 2025
• Study Completion (Estimated): August 18, 2026
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)