CTRI/2023/12/060680
尚未招募
不适用
A randomized controlled trial to assess the effectiveness of Artificial intelligence based game AINAR to conquer needle fear in blood donors.
All India Institute of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年1月1日最近更新:
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- All India Institute of Medical Sciences, New Delhi
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Needle fear and frequency of vasovagal reaction in blood donors
概览
简要总结
This study is a parallel group randomized trial assessing the effectiveness of a artificial intelligence based game , AINAR to conquer the needle fear in blood donors. This sample size will be 1500 each in the AINAR game group as well as in the control group over a period of 1 year in a blood center in India. The primary outcome will be the assessment of needle fear and immediate type vasovagal reaction during blood donation procedure. The secondary outcome will be the assessment of effectiveness of AINAR game in the prevention of VVR and association of needle fear with VVR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.All young male and female donors aged between 18-30 years 2.All first-time donors 3.Repeat donors with a history of VVR in previous donation.
排除标准
- •1.Donors not giving consent 2.Repeat donors with ≥2 VVRs in previous donations 3.Donors with incomplete donation except for VVR.
结局指标
主要结局
Needle fear and frequency of vasovagal reaction in blood donors
时间窗: At baseline.
次要结局
- Effectiveness of AINAR game in VVR prevention(Association of Needle fear with VVR)
研究者
Gopal Kumar Patidar
AIIMS New Delhi
研究点 (1)
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