xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06014346</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL22_0131</org_study_id>
      <nct_id>NCT06014346</nct_id>
    </id_info>
    <brief_title>Prospective Study of the Prevention of Vasovagal Reactions in First-time Whole Blood Donors Using a Combined PSYchological and Physiological Approach</brief_title>
    <acronym>PREDONPSY</acronym>
    <official_title>Prospective Study of the Prevention of Vasovagal Reactions in First-time Whole Blood Donors Using a Combined PSYchological and Physiological Approach: PREDONPSY</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The prevention of vasovagal reactions (VVR) occurring during or after donation is a major&#xD;
        issue for the French Blood Establishment (EFS), firstly to guarantee the safety of donors but&#xD;
        also to retain them, as this reaction is one of the negative experiences affecting the return&#xD;
        to donation.&#xD;
  &#xD;
        The EVASION study conducted in the Auvergne Rhône-Alpes region (AURA) on 4828 donors&#xD;
        representative of the French donor population, reported a beneficial effect of muscle&#xD;
        contraction exercises to prevent the occurrence of VVR during donation, while hydric&#xD;
        solutions, and even more so isotonic solutions, were likely to decrease the frequency of&#xD;
        delayed VVR.&#xD;
  &#xD;
        These preventive measures have been integrated into the internal guidelines and currently&#xD;
        include muscular and breathing exercises and hydration. Nevertheless, the isotonic solution&#xD;
        could not be routinely deployed for feasibility and cost reasons. A salty snack could replace&#xD;
        the isotonic solution to produce the same effects with better feasibility and acceptability.&#xD;
        Furthermore, a significant proportion of discomfort is psychological in origin, related to&#xD;
        stress and anxiety which persist despite these measures, particularly in the first-time donor&#xD;
        population.&#xD;
  &#xD;
        These measures, which are mainly focused on the prevention of VVR of physiological origin,&#xD;
        are still insufficient and can be optimized and complemented to reduce the occurrence of VVR,&#xD;
        especially in first-time donors for whom anxiety and stress play an important role in the&#xD;
        etiology of VVR.&#xD;
  &#xD;
        Two measures could further reduce the occurrence of VVR:&#xD;
  &#xD;
          -  Reinforcement of the physiological strategy: ingestion of a salty snack before donation,&#xD;
             the effect of which could be similar to the effect of the isotonic solution, which could&#xD;
             not be delivered in practice because of its cost following the data of the EVASION&#xD;
             study.&#xD;
  &#xD;
          -  Addition of a psychological strategy: flyer given at the interview presenting the four&#xD;
             most frequent fears as well as a description of the recommended muscular and respiratory&#xD;
             exercises, followed by the execution of the recommended exercises before the sampling.&#xD;
  &#xD;
        Our hypothesis is that the combination of a psychological and physiological strategies would&#xD;
        allow a reduction of the occurrence of immediate and/or 48 h delayed VVR during the whole&#xD;
        blood donation in first time donors compared to the current practices.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">August 18, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 18, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Vasovagal reactions (VVR)</measure>
      <time_frame>Day 1 = donation day ; Day 3 = 48h post donation</time_frame>
      <description>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)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>VVR psychological strategy</measure>
      <time_frame>Day 1 = donation day ; Day 3= 48h post donation</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VVR physiological strategy</measure>
      <time_frame>Day 1 = donation day ; Day 3= 48h post donation</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immediate VVR</measure>
      <time_frame>Day 1 = donation day, before leaving the centre</time_frame>
      <description>Proportion of first-time donors with immediate VVR compared between the groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Delayed VVR</measure>
      <time_frame>Day 3= 48h post donation</time_frame>
      <description>Proportion of first-time donors with delayed VVR compared between the groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First-time donor adherence</measure>
      <time_frame>Day 1 = donation day, before leaving the centre</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety/fear</measure>
      <time_frame>Day 1 = donation day, before donation</time_frame>
      <description>Assessment of the evolution of the &quot;anxiety/fear&quot; score between arrival and before the whole blood donation, compared between the groups.&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sense of control and fears</measure>
      <time_frame>Day 1 = donation day, before donation</time_frame>
      <description>Assessment of the &quot;sense of control and fears&quot; score, compared between the groups.&#xD;
  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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Feelings of discomfort</measure>
      <time_frame>Day 1 = donation day, after donation and before leaving the centre</time_frame>
      <description>Assessment of the &quot;feelings of discomfort&quot; 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;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>First-time donor retention</measure>
      <time_frame>Month 12 following the first-time donation</time_frame>
      <description>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</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">5320</enrollment>
    <condition>Vasovagal Reaction</condition>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>EFS usual standard practices for the whole blood donation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A psychological strategy is added to EFS standard practices before the whole blood donation&#xD;
  flyer given at the interview presenting the 4 most frequent fears as well as a description of the recommended muscular and breathing exercises,&#xD;
  followed by a training of these exercises and their execution</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test Group 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A physiological strategy is added to EFS standard practices before the whole blood donation : - Ingesting a salty snack.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test group 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The both psychological and physiological strategies are added to EFS standard practices before the whole blood donation&#xD;
  flyer given at the interview presenting the 4 most frequent fears as well as a description of the recommended muscular and breathing exercises,&#xD;
  followed by a training of these exercises and their execution Ingesting a salty snack.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Psychological strategy</intervention_name>
      <description>flyer given at the interview presenting the 4 most frequent fears as well as a description of the recommended muscular and breathing exercises,&#xD;
  then realization accompanied by a training of these exercises</description>
      <arm_group_label>Test Group 1</arm_group_label>
      <arm_group_label>Test group 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Physiological strategy</intervention_name>
      <description>- ingesting a salty snack</description>
      <arm_group_label>Test Group 2</arm_group_label>
      <arm_group_label>Test group 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  M/F between 18 and 70 years old,&#xD;
  &#xD;
            -  A first-time donor who wishes to donate blood in Lyon, either at a fixed site or at a&#xD;
               mobile unit,&#xD;
  &#xD;
            -  Declared fit to donate whole blood after the EFS pre-donation interview,&#xD;
  &#xD;
            -  Weight ≥ 50kg and height ≥ 135 cm,&#xD;
  &#xD;
            -  Available for telephone contact between to 5d +/- 2 days after donation,&#xD;
  &#xD;
            -  Having signed a written consent to participate in the study.&#xD;
  &#xD;
          Non-inclusion criteria:&#xD;
  &#xD;
            -  Known allergy to shellfish, and/or gluten, and/or milk, and/or soy,&#xD;
  &#xD;
            -  Incomprehension of the French language,&#xD;
  &#xD;
            -  First-time donor under protective measures (guardian, curator) or any other&#xD;
               administrative measure,&#xD;
  &#xD;
            -  Not affiliated to the French social security system or any other equivalent system,&#xD;
  &#xD;
            -  Pregnant or breastfeeding woman,&#xD;
  &#xD;
            -  Subject participating in any other interventional or non-interventional research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Withdrawal of consent&#xD;
  &#xD;
            -  First-time donor with anemia following routine hemoglobin testing&#xD;
  &#xD;
            -  First-time donor not reachable for telephone interview&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Brice MD POREAU</last_name>
      <phone>478 656 137</phone>
      <phone_ext>+33</phone_ext>
      <email>brice.poreau@efs.sante.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Julie MD-PhD HAESEBAERT</last_name>
      <phone>472 115 732</phone>
      <phone_ext>+33</phone_ext>
      <email>julie.haesebaert@chu-lyon.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>French Blood Establishment (EFS)</name>
        <address>
          <city>Lyon</city>
          <zip>69153</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Brice MD POREAU, MD/PhD</last_name>
        <phone>478 656 137</phone>
        <phone_ext>+33</phone_ext>
        <email>brice.poreau@efs.sante.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>first time donor</keyword>
    <keyword>whole blood donation</keyword>
    <keyword>vasovagal Reaction</keyword>
    <keyword>physiological</keyword>
    <keyword>psychological</keyword>
    <keyword>BDRI</keyword>
    <keyword>BDAS</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Syncope, Vasovagal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06014346
  org study id: 69HCL22_0131
  nct id: NCT06014346
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  
        Our 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Vasovagal reactions (VVR)
  time frame: Day 1 = donation day ; Day 3 = 48h post donation
  description: 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)
  measure: VVR psychological strategy
  time frame: Day 1 = donation day ; Day 3= 48h post donation
  description: 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)
  measure: VVR physiological strategy
  time frame: Day 1 = donation day ; Day 3= 48h post donation
  description: 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)
  measure: Immediate VVR
  time frame: Day 1 = donation day, before leaving the centre
  description: Proportion of first-time donors with immediate VVR compared between the groups
  measure: Delayed VVR
  time frame: Day 3= 48h post donation
  description: Proportion of first-time donors with delayed VVR compared between the groups
  measure: First-time donor adherence
  time frame: Day 1 = donation day, before leaving the centre
  description: 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).
  measure: Anxiety/fear
  time frame: Day 1 = donation day, before donation
  description: 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.
  measure: Sense of control and fears
  time frame: Day 1 = donation day, before donation
  description: 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.
  measure: Feelings of discomfort
  time frame: Day 1 = donation day, after donation and before leaving the centre
  description: 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;
  measure: First-time donor retention
  time frame: Month 12 following the first-time donation
  description: 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
  arm group label: Control group
  arm group type: No Intervention
  description: EFS usual standard practices for the whole blood donation
  arm group label: Test Group 1
  arm group type: Experimental
  description: 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
  arm group label: Test Group 2
  arm group type: Experimental
  description: A physiological strategy is added to EFS standard practices before the whole blood donation : - Ingesting a salty snack.
  arm group label: Test group 3
  arm group type: Experimental
  description: 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.
  intervention type: Procedure
  intervention name: Psychological strategy
  description: 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
  arm group label: Test Group 1
  arm group label: Test group 3
  intervention type: Procedure
  intervention name: Physiological strategy
  description: - ingesting a salty snack
  arm group label: Test Group 2
  arm group label: Test group 3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Brice MD POREAU
  phone: 478 656 137
  phone ext: +33
  email: brice.poreau@efs.sante.fr
  last name: Julie MD-PhD HAESEBAERT
  phone: 472 115 732
  phone ext: +33
  email: julie.haesebaert@chu-lyon.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Syncope, Vasovagal
  sharing ipd: No