NCT02742025已完成不适用
Evaluation of the Effect of an Educational and Explanatory Program for a Surgical Act Provided to the Patient Prior to Said Act on Preoperative Anxiety - a Pilot Study at the Nîmes University Hospital on Elective Coronary Angiography
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2019年11月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Amsterdam Preoperative Anxiety and Information Scale (APAIS)
研究概览
简要总结
The main objective of this study is to evaluate the impact on preoperative anxiety of an education and information program conducted prior to non-urgent coronary angiography performed in patients hospitalized at the Nîmes University Hospital.
详细描述
The secondary objectives of this study are to assess the impact of the HEARTLINK program on the following parameters:
A. Duration of hospital stay; B. Per operative blood and heart rate?; C. Patient satisfaction (visual analog scale).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Patient for whom elective coronary angiography is indicated
- •The patient has never had a coronary angiography before
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant or breastfeeding
- •The subject has already had a coronary angiography
- •The subject has a cognitive impairment
结局指标
主要结局
Amsterdam Preoperative Anxiety and Information Scale (APAIS)
时间窗: Day 0 (within 1 hour preceding a coronography)
次要结局
- Cardiac frequency (beats per minute)(Day 0 (within 1 hour preceding a coronography))
- Duration of hospitalization(Date hospital discharge (expected maximum of 5 days))
- Visual analog scale for satisfaction concerning care(Day 0 (within 1 hour preceding a coronography))
- Blood pressure(Day 0 (within 1 hour preceding a coronography))
研究者
研究点 (2)
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