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Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Primary Purpose

Blood Donors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fear Intervention
Sponsored by
Ohio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Blood Donors focused on measuring blood donor, fear, vasovagal reaction

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • To be eligible for inclusion in this study, the individual must have presented to donate blood at a New York Blood Center high school blood drive where data is being collected and have passed the health screening process.

Exclusion Criteria:

  • Less than 16 years of age; inability to read and comprehend English

Sites / Locations

  • Ohio University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Fear Control

Fear Intervention

No Fear Control

Arm 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.

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.

Participants who report no blood donation-related fear will proceed through the normal blood donation process.

Outcomes

Primary Outcome Measures

Repeat Blood Donation Attempts
Donor records will be used to track subsequent donation attempts during the follow-up.

Secondary Outcome Measures

Blood Donation Confidence
Confidence in ability to cope with any donation-related fear
Vasovagal Reactions to Blood Donation
phlebotomist ratings of blood donor vasovagal reactions

Full Information

First Posted
February 7, 2019
Last Updated
September 14, 2021
Sponsor
Ohio University
Collaborators
New York Blood Center
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1. Study Identification

Unique Protocol Identification Number
NCT03835299
Brief Title
Addressing Fear and Risk of Vasovagal Reactions Among High School Donors
Official Title
Addressing Fear and Risk of Vasovagal Reactions Among High School Donors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
January 15, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio University
Collaborators
New York Blood Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Donors
Keywords
blood donor, fear, vasovagal reaction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
4035 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fear Control
Arm Type
No Intervention
Arm 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 Title
Fear Intervention
Arm Type
Experimental
Arm 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 Title
No Fear Control
Arm Type
No Intervention
Arm Description
Participants who report no blood donation-related fear will proceed through the normal blood donation process.
Intervention Type
Behavioral
Intervention Name(s)
Fear Intervention
Intervention Description
Coping information related to the fear that was identified by the participant will be presented via a computer tablet.
Primary Outcome Measure Information:
Title
Repeat Blood Donation Attempts
Description
Donor records will be used to track subsequent donation attempts during the follow-up.
Time Frame
two years post-donation
Secondary Outcome Measure Information:
Title
Blood Donation Confidence
Description
Confidence in ability to cope with any donation-related fear
Time Frame
immediately pre-donation
Title
Vasovagal Reactions to Blood Donation
Description
phlebotomist ratings of blood donor vasovagal reactions
Time Frame
immediately post-donation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible for inclusion in this study, the individual must have presented to donate blood at a New York Blood Center high school blood drive where data is being collected and have passed the health screening process. Exclusion Criteria: Less than 16 years of age; inability to read and comprehend English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher R France, PhD
Organizational Affiliation
Ohio University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio University
City
Athens
State/Province
Ohio
ZIP/Postal Code
45701
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

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