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Completed

NCT Number: NCT03835299

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.

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Key information

Conditions

Blood Donors Autonomic Nervous System Diseases Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Orthostatic Intolerance Pathological Conditions, Signs and Symptoms Primary Dysautonomias Signs and Symptoms Syncope Syncope, Vasovagal Unconsciousness

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fear Intervention

Behavioral

Coping information related to the fear that was identified by the participant will be presented via a computer tablet.

Primary outcomes

  1. Repeat Blood Donation Attempts

    Time frame: two years post-donation

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

Secondary outcomes

  1. Blood Donation Confidence

    Time frame: immediately pre-donation

    Confidence in ability to cope with any donation-related fear

  2. Vasovagal Reactions to Blood Donation

    Time frame: immediately post-donation

    phlebotomist ratings of blood donor vasovagal reactions

Sponsors and collaborators

Lead sponsor

Ohio University

Other

Collaborators

  • New York Blood Center

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 8, 2019
Registry last updated
Sep 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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