Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

Qazvin University Of Medical Sciences

Status: Unknown

Conditions: Sexual Dysfunction; Takotsubo Cardiomyopathy

Treatments: Behavioral: Mindfulness-Based Sex Therapy; Other: Treatment as usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03372577

IR.QUMS.REC.1396.188

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• cognitive disability
• having acute myocardial infarction
• cerebrovascular disease
• pheochromocytoma and viral or idiopathic myocarditis
• , participating in another RCT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 3 patient groups

patient and partner

Experimental group

Treatment:

Behavioral: Mindfulness-Based Sex Therapy

patient ,partner and cardiac rehabilitation team

Experimental group

Treatment:

Behavioral: Mindfulness-Based Sex Therapy

Treatment as usual

Active Comparator group

Treatment:

Other: Treatment as usual