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Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03835299
Enrollment
4035
Registered
2019-02-08
Start date
2019-02-15
Completion date
2020-01-15
Last updated
2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Donors

Keywords

blood donor, fear, vasovagal reaction

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.

Interventions

BEHAVIORALFear Intervention

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

Sponsors

New York Blood Center
CollaboratorOTHER
Ohio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
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.

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Repeat Blood Donation Attemptstwo years post-donationDonor records will be used to track subsequent donation attempts during the follow-up.

Secondary

MeasureTime frameDescription
Blood Donation Confidenceimmediately pre-donationConfidence in ability to cope with any donation-related fear
Vasovagal Reactions to Blood Donationimmediately post-donationphlebotomist ratings of blood donor vasovagal reactions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026