Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Not Applicable

Completed

• Conditions: Blood Donors
• Interventions: Behavioral: Fear Intervention

• Registration Number: NCT03835299
• Lead Sponsor: Ohio University

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.

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-08
• Study Start: 2019-02-15
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4035

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fear Intervention	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ohio University; 🇺🇸 Athens, Ohio, United States