Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

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.

Study Overview

• Status: Completed
• Conditions: Blood Donors
• Intervention / Treatment: Behavioral: Fear 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.

• Study Type: Interventional
• Enrollment (Actual): 4035
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Athens, Ohio, United States, 45701
      • Ohio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Fear Control; 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.
EXPERIMENTAL: Fear Intervention; 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.	Behavioral: Fear Intervention; Coping information related to the fear that was identified by the participant will be presented via a computer tablet.
NO_INTERVENTION: No Fear Control; Participants who report no blood donation-related fear will proceed through the normal blood donation process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Repeat Blood Donation Attempts	Donor records will be used to track subsequent donation attempts during the follow-up.	two years post-donation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Donation Confidence	Confidence in ability to cope with any donation-related fear	immediately pre-donation
Vasovagal Reactions to Blood Donation	phlebotomist ratings of blood donor vasovagal reactions	immediately post-donation

Collaborators and Investigators

• Sponsor: Ohio University
• Collaborators: New York Blood Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2019
• Primary Completion (ACTUAL): January 15, 2020
• Study Completion (ACTUAL): January 15, 2020

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (ACTUAL): February 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: blood donor, fear, vasovagal reaction
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: NYBC 1243761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No