Vasovagal ReactionPREDONPSYNCT06014346
Prevention of Vasovagal Reactions in First-time Blood Donors Using a Combined PSYchological and Physiological Approach
A study testing Psychological strategy and Physiological strategy in people with Vasovagal Reaction, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasovagal Reaction
- What is being tested?
- Psychological strategy and Physiological strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,320 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2023to 18 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- Non-inclusion criteria:
- 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
Who cannot join
- Withdrawal of consent
- First-time donor with anemia following routine hemoglobin testing
- First-time donor not reachable for telephone interview
Trial locations and contacts
1 site in 1 country.
France1 site
French Blood Establishment (EFS)
Lyon, 69153
Brice MD POREAU, MD/PhD, 478 656 137 ext. +33, brice.poreau@efs.sante.fr
About this study
Official title: Prospective Study of the Prevention of Vasovagal Reactions in First-time Whole Blood Donors Using a Combined PSYchological and Physiological Approach: PREDONPSY
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.
Read more
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
- Being tested
- Psychological strategy, Physiological strategy
- Keywords
- first time donor, whole blood donation, vasovagal Reaction, physiological, psychological, BDRI, BDAS
- Medical subject headings
- Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological strategyOther
- 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 strategyOther
- ingesting a salty snack
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: Other: Psychological strategy; Other: Physiological strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1 = donation day ; Day 3 = 48h post donation
Secondary outcomes (9)
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)
Measured: Day 1 = donation day ; Day 3= 48h post donation
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)
Measured: Day 1 = donation day ; Day 3= 48h post donation
Immediate VVR
Proportion of first-time donors with immediate VVR compared between the groups
Measured: Day 1 = donation day, before leaving the centre
Delayed VVR
Proportion of first-time donors with delayed VVR compared between the groups
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Month 12 following the first-time donation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start10 Oct 2023 (estimated)
- Primary completion18 May 2025 (estimated)
- Study completion18 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasovagal ReactionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06014346
- Sponsor's protocol ID
- 69HCL22_0131
- Acronym
- PREDONPSY
- Status last verified
- Sep 2023
- First submitted
- 21 Aug 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Prevention of Vasovagal Reactions in First-time Whole Blood Donors Using a Combined PSYchological and Physiological Approach: PREDONPSY
- ClinicalTrials.gov ID
- NCT06014346
- Acronym / sponsor ID
- PREDONPSY / 69HCL22_0131
- Conditions
- Vasovagal Reaction
- Keywords
- first time donor, whole blood donation, vasovagal Reaction, physiological, psychological, BDRI, BDAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,320 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 10 Oct 2023 (estimated)
- Primary completion
- 18 May 2025 (estimated)
- Study completion
- 18 Aug 2026 (estimated)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –EFS usual standard practices for the whole blood donation |
| Test Group 1 | Experimental | Other: Psychological strategyA 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 |
| Test Group 2 | Experimental | Other: Physiological strategyA physiological strategy is added to EFS standard practices before the whole blood donation : - Ingesting a salty snack. |
| Test group 3 | Experimental | Other: Psychological strategy, Other: Physiological strategyThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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,
Key exclusion criteria (3 listed)
- Withdrawal of consent
- First-time donor with anemia following routine hemoglobin testing
- First-time donor not reachable for telephone interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological strategy* 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 | Other | Test Group 1, Test group 3 |
| Physiological strategy- ingesting a salty snack | Other | Test Group 2, Test group 3 |
Primary outcome
Vasovagal reactions (VVR)
Time frame: Day 1 = donation day ; Day 3 = 48h post donation
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)
9 secondary outcomes
VVR psychological strategy
Time frame: Day 1 = donation day ; Day 3= 48h post donation
VVR physiological strategy
Time frame: Day 1 = donation day ; Day 3= 48h post donation
Immediate VVR
Time frame: Day 1 = donation day, before leaving the centre
Delayed VVR
Time frame: Day 3= 48h post donation
First-time donor adherence
Time frame: Day 1 = donation day, before leaving the centre
Anxiety/fear
Time frame: Day 1 = donation day, before donation
Sense of control and fears
Time frame: Day 1 = donation day, before donation
Feelings of discomfort
Time frame: Day 1 = donation day, after donation and before leaving the centre
First-time donor retention
Time frame: Month 12 following the first-time donation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological strategy and Physiological strategy in people with Vasovagal Reaction, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brice MD POREAU (478 656 137 ext. +33, brice.poreau@efs.sante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasovagal reactions (VVR) (time frame: Day 1 = donation day ; Day 3 = 48h post donation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.