<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/NCT03835299</url>
  </required_header>
  <id_info>
    <org_study_id>NYBC 1243761</org_study_id>
    <nct_id>NCT03835299</nct_id>
  </id_info>
  <brief_title>Addressing Fear and Risk of Vasovagal Reactions Among High School Donors</brief_title>
  <official_title>Addressing Fear and Risk of Vasovagal Reactions Among High School Donors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>New York Blood Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ohio University</source>
  <oversight_info>
    <has_dmc>No</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>
      In this study, high school donors will be asked about their blood donation-related fears&#xD;
      prior to their donation. Half of the donors reporting fear will be assigned to a brief coping&#xD;
      skills intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study the investigators will ask high school donors about their blood&#xD;
      donation-related fears prior to their donation. Among those who report donation fear, half&#xD;
      will be randomly assigned to receive a brief presentation of coping strategies administered&#xD;
      via a computer tablet. The investigators will compare reaction rates and return behavior for&#xD;
      the donors and high school drives where the study was conducted to the reaction and retention&#xD;
      rates from similar blood drives where no data was collected. The investigators will also&#xD;
      examine whether asking about the specific types of fear improves the prediction of syncopal&#xD;
      or presyncopal reactions beyond the predictive value of a single fear question. Finally, the&#xD;
      investigators will examine whether providing coping information to help manage the fear&#xD;
      improves syncopal reaction rates and/or donor retention rates among fearful donors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2019</start_date>
  <completion_date type="Actual">January 15, 2020</completion_date>
  <primary_completion_date type="Actual">January 15, 2020</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>Basic Science</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Investigators are masked because the participants are randomized and the intervention is delivered by a computer tablet. The outcome assessor is masked because donation-related data is recorded by blood collection staff who are unaware that donors may be participants in a study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Repeat Blood Donation Attempts</measure>
    <time_frame>two years post-donation</time_frame>
    <description>Donor records will be used to track subsequent donation attempts during the follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood Donation Confidence</measure>
    <time_frame>immediately pre-donation</time_frame>
    <description>Confidence in ability to cope with any donation-related fear</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasovagal Reactions to Blood Donation</measure>
    <time_frame>immediately post-donation</time_frame>
    <description>phlebotomist ratings of blood donor vasovagal reactions</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">4035</enrollment>
  <condition>Blood Donors</condition>
  <arm_group>
    <arm_group_label>Fear Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants who report blood donation-related fear who are assigned to this study arm will answer several questions then proceed through the normal blood donation process.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fear Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants who report blood donation-related fear who are assigned to this study arm will answer several questions and view a brief presentation of coping strategies presented via a computer tablet. They will then proceed through the normal blood donation process.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Fear Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants who report no blood donation-related fear will proceed through the normal blood donation process.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fear Intervention</intervention_name>
    <description>Coping information related to the fear that was identified by the participant will be presented via a computer tablet.</description>
    <arm_group_label>Fear Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  To be eligible for inclusion in this study, the individual must have presented to&#xD;
             donate blood at a New York Blood Center high school blood drive where data is being&#xD;
             collected and have passed the health screening process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 16 years of age; inability to read and comprehend English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher R France, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio University</name>
      <address>
        <city>Athens</city>
        <state>Ohio</state>
        <zip>45701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>September 14, 2021</last_update_submitted>
  <last_update_submitted_qc>September 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio University</investigator_affiliation>
    <investigator_full_name>Christopher R. France, Ph.D.</investigator_full_name>
    <investigator_title>Distinguished Professor of Psychology</investigator_title>
  </responsible_party>
  <keyword>blood donor, fear, vasovagal reaction</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>


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/NCT03835299
org study id: NYBC 1243761
nct id: NCT03835299
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, high school donors will be asked about their blood donation-related fears
      prior to their donation. Half of the donors reporting fear will be assigned to a brief coping
      skills intervention.
In this study the investigators will ask high school donors about their blood
      donation-related fears prior to their donation. Among those who report donation fear, half
      will be randomly assigned to receive a brief presentation of coping strategies administered
      via a computer tablet. The investigators will compare reaction rates and return behavior for
      the donors and high school drives where the study was conducted to the reaction and retention
      rates from similar blood drives where no data was collected. The investigators will also
      examine whether asking about the specific types of fear improves the prediction of syncopal
      or presyncopal reactions beyond the predictive value of a single fear question. Finally, the
      investigators will examine whether providing coping information to help manage the fear
      improves syncopal reaction rates and/or donor retention rates among fearful donors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
masking description: Investigators are masked because the participants are randomized and the intervention is delivered by a computer tablet. The outcome assessor is masked because donation-related data is recorded by blood collection staff who are unaware that donors may be participants in a study.
measure: Repeat Blood Donation Attempts
time frame: two years post-donation
description: Donor records will be used to track subsequent donation attempts during the follow-up.
measure: Blood Donation Confidence
time frame: immediately pre-donation
description: Confidence in ability to cope with any donation-related fear
measure: Vasovagal Reactions to Blood Donation
time frame: immediately post-donation
description: phlebotomist ratings of blood donor vasovagal reactions
arm group label: Fear Control
arm group type: No Intervention
description: Participants who report blood donation-related fear who are assigned to this study arm will answer several questions then proceed through the normal blood donation process.
arm group label: Fear Intervention
arm group type: Experimental
description: Participants who report blood donation-related fear who are assigned to this study arm will answer several questions and view a brief presentation of coping strategies presented via a computer tablet. They will then proceed through the normal blood donation process.
arm group label: No Fear Control
arm group type: No Intervention
description: Participants who report no blood donation-related fear will proceed through the normal blood donation process.
intervention type: Behavioral
intervention name: Fear Intervention
description: Coping information related to the fear that was identified by the participant will be presented via a computer tablet.
arm group label: Fear Intervention
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher R France, PhD
role: Principal Investigator
affiliation: Ohio University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio University
investigator full name: Christopher R. France, Ph.D.
investigator title: Distinguished Professor of Psychology
mesh term: Syncope, Vasovagal
sharing ipd: No