Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy Among Iranian Women
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Intimacy
研究概览
简要总结
Takotsubo cardiomyopathy (TC) is a type of non-ischemic cardiomyopathy in which there is a sudden temporary weakening of the myocardium. . In a recent study, women report more sexual dysfunction than men after 1 year after TC. Despite that a number of studies have assessed female sexual dysfunction (FSD) for TC , there is no information regarding prevalence and associated factors on FSD in women with TC. However, in a recent study on Iranian female patients with TC, more than 77% of these patients suffered from FSD. This study is aimed to assess the effectiveness of a Mindfulness-based Sex Therapy on Patients With TC.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •aged 18 years old at least
- •confirmed diagnosis of TC by a cardiologist according Mayo Clinic diagnostic criteria; an acute left ventricular apical ballooning of unknown cause
- •willingness to partaking for the duration of the trial
- •a basic fluency in Persian
- •living with a partner/spouse
排除标准
- •cognitive disability
- •having acute myocardial infarction
- •cerebrovascular disease
- •pheochromocytoma and viral or idiopathic myocarditis
- •, participating in another RCT
研究组 & 干预措施
patient and partner
干预措施: Mindfulness-Based Sex Therapy (Behavioral)
patient ,partner and cardiac rehabilitation team
干预措施: Mindfulness-Based Sex Therapy (Behavioral)
Treatment as usual
干预措施: Treatment as usual (Other)
结局指标
主要结局
Intimacy
时间窗: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Personal Assessment of Intimacy in Relationships (PAIR) will use to assess relationship satisfaction. The PAIR is a self-reported measure with 36 items which cover five subscales
Sexual functioning
时间窗: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
Sexual Distress
时间窗: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Female Sexual Distress Scale;The FSDS-R is a self-reported questionnaire consisting of 13 items assessing different aspects of sexual activity-related distress in women
次要结局
- Emotion regulation(changes from baseline, 1 Months ,6 months, 12 months and 18 months)
- quality of life(changes from baseline, 1 Months ,6 months, 12 months and 18 months)
- Mindfulness(changes from baseline, 1 Months ,6 months, 12 months and 18 months)
- Marital satisfaction(changes from baseline, 1 Months ,6 months, 12 months and 18 months)
- Rumination(changes from baseline, 1 Months ,6 months, 12 months and 18 months)
- Social Support(changes from baseline, 1 Months ,6 months, 12 months and 18 months)
- Sense of Coherence(changes from baseline, 1 Months ,6 months, 12 months and 18 months)
- Psychological distress(changes from baseline, 1 Months ,6 months, 12 months and 18 months)
研究者
Amir H Pakpour
Director of Social Determinants of Health Research Center (SDH)
Qazvin University Of Medical Sciences