NCT04252729已完成不适用
Effect of Psychotherapy on Quality of Life and Recurrence of Events in Patients With Recurrent Vasovagal Syncope: A Randomized Pilot Study
Mauricio Ibrahim Scanavacca2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2017年7月27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
- 10
- 试验地点
- 2
- 主要终点
- Quality of life analysis performed by the Short Form 36 Instrument
研究概览
简要总结
Recurrent vasovagal syncope although presenting a benign prognosis in terms of survival, is associated with significant impairment of quality of life. The impaired emotional status is also related to the recurrence of the events, closing a negative cycle for the evolution of the disease. This study aims to evaluate the effect of psychotherapy on the quality of life and in the number of syncope and pre-syncope events during one year of follow-up of patients with recurrent vasovagal syncope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of vasovagal syncope with positive TILT TEST and recurrent episodes (≥2 episode within 6 months)
- •Signed Free and Informed Consent Form
排除标准
- •Severe comorbidity with life expectancy <1 year
- •Age <18 years
- •Current psychotherapeutic follow-up
- •Cardiac or neurological syncope
- •Pregnancy
结局指标
主要结局
Quality of life analysis performed by the Short Form 36 Instrument
时间窗: 12 months
Data collected at 12 months (global assessment and by specific domains).
次要结局
- Number of comorbidities(12 months)
- Use of concomitant medication(12 months)
- Demographic data(12 months)
研究者
Mauricio Ibrahim Scanavacca
Arrhythmia Clinical Unit Director
University of Sao Paulo General Hospital
研究点 (2)
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