Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

NCT03835299 | Completed

• 1 other identifier: NYBC 1243761
• Study Type: interventional
• Target: 4,035
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Donors

Keywords

blood donor, fear, vasovagal reaction

Outcome Measures

Primary Outcomes (1)

• Repeat Blood Donation Attempts

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

  two years post-donation

Secondary Outcomes (2)

• Blood Donation Confidence

  immediately pre-donation

• Vasovagal Reactions to Blood Donation

  immediately post-donation

Study Arms (3)

Fear Control

NO INTERVENTION

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.

Fear Intervention

EXPERIMENTAL

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

No Fear Control

NO INTERVENTION

Participants who report no blood donation-related fear will proceed through the normal blood donation process.

Interventions

Fear Intervention BEHAVIORAL

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

Fear Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Less than 16 years of age; inability to read and comprehend English

Sponsors & Collaborators

• Ohio University: lead
• New York Blood Center: collaborator

Study Sites (1)

Ohio University

Athens, Ohio, 45701, United States

Location

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher R France, PhD

  Ohio University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor of Psychology

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 8, 2019
• Study Start: February 15, 2019
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)