Addressing Fear and Risk of Vasovagal Reactions Among High School Donors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,035
- 试验地点
- 1
- 主要终点
- Repeat Blood Donation Attempts
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Less than 16 years of age; inability to read and comprehend English
研究组 & 干预措施
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.
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.
干预措施: Fear Intervention (Behavioral)
No Fear Control
Participants who report no blood donation-related fear will proceed through the normal blood donation process.
结局指标
主要结局
Repeat Blood Donation Attempts
时间窗: two years post-donation
Donor records will be used to track subsequent donation attempts during the follow-up.
次要结局
- Vasovagal Reactions to Blood Donation(immediately post-donation)
- Blood Donation Confidence(immediately pre-donation)
研究者
Christopher R. France, Ph.D.
Distinguished Professor of Psychology
Ohio University