Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Blood Donors Clinical Trial

Official title:

Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03835299
• Other study ID #: NYBC 1243761
• Status: Completed
• Phase: N/A
• Start date: February 15, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: September 2021
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4035
• Est. completion date: January 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Donors
• Syncope, Vasovagal

Intervention

Behavioral:
• Fear Intervention
Coping information related to the fear that was identified by the participant will be presented via a computer tablet.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio University	New York Blood Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeat Blood Donation Attempts	Donor records will be used to track subsequent donation attempts during the follow-up.	two years post-donation
Secondary	Blood Donation Confidence	Confidence in ability to cope with any donation-related fear	immediately pre-donation
Secondary	Vasovagal Reactions to Blood Donation	phlebotomist ratings of blood donor vasovagal reactions	immediately post-donation