Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Sponsor

Ohio University (Other)

Overall Status

Completed

CT.gov ID

NCT03835299

Collaborator

New York Blood Center (Other)

4,035

Enrollment

Location

Arms

Actual Duration (Months)

367.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Donors	Behavioral: Fear Intervention	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

4035 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.

Primary Purpose:

Basic Science

Official Title:

Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

Actual Study Start Date :

Feb 15, 2019

Actual Primary Completion Date :

Jan 15, 2020

Actual Study Completion Date :

Jan 15, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio University	Athens	Ohio	United States	45701

Sponsors and Collaborators

Ohio University
New York Blood Center

Investigators

Principal Investigator: Christopher R France, PhD, Ohio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christopher R. France, Ph.D., Distinguished Professor of Psychology, Ohio University

ClinicalTrials.gov Identifier:

NCT03835299

Other Study ID Numbers:

NYBC 1243761

First Posted:

Feb 8, 2019

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Christopher R. France, Ph.D., Distinguished Professor of Psychology, Ohio University

blood donor, fear, vasovagal reaction

Additional relevant MeSH terms:

Syncope, Vasovagal

Study Results

No Results Posted as of Sep 16, 2021