Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

Not Applicable

• Conditions: Sexual Dysfunction; Takotsubo Cardiomyopathy
• Interventions: Behavioral: Mindfulness-Based Sex Therapy; Other: Treatment as usual

• Registration Number: NCT03372577
• Lead Sponsor: Qazvin University Of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-12
• Study Start: 2017-12-01
• Study First Submitted: 2017-12-09
• Study First Submitted QC: 2017-12-09
• Last Update Submitted: 2017-12-09
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13
• Primary Completion: 2018-12-01
• Study Completion: 2019-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient ,partner and cardiac rehabilitation team	Mindfulness-Based Sex Therapy	-
patient and partner	Mindfulness-Based Sex Therapy	-
Treatment as usual	Treatment as usual	-

Primary Outcome Measures

Name	Time	Method
Intimacy	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	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	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

Secondary Outcome Measures

Name	Time	Method
Emotion regulation	changes from baseline, 1 Months ,6 months, 12 months and 18 months	Persons' emotions in response to stressful life events is measured using he Cognitive Emotion Regulation Questionnaire short version (CERQ-short).
quality of life	changes from baseline, 1 Months ,6 months, 12 months and 18 months	HRQoL is measured using Short Form health survey (SF-12).
Mindfulness	changes from baseline, 1 Months ,6 months, 12 months and 18 months	Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters
Marital satisfaction	changes from baseline, 1 Months ,6 months, 12 months and 18 months	The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
Rumination	changes from baseline, 1 Months ,6 months, 12 months and 18 months	Rumination is measured using Ruminative Thought Style Questionnaire (RTS). The RTS contains 20 items describing positive, negative and neutral facets of global rumination
Social Support	changes from baseline, 1 Months ,6 months, 12 months and 18 months	Social support will be assessed by the ENRICHD Social Support Inventory (ESSI ).
Sense of Coherence	changes from baseline, 1 Months ,6 months, 12 months and 18 months	Sense of coherence will be measured using the Antonovsky's 13-item sense of coherence scale (SOC-13).
Psychological distress	changes from baseline, 1 Months ,6 months, 12 months and 18 months	Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations

Trial Locations

Locations (1)

Booali Sina Hospital; 🇮🇷 Qazvin, Iran, Islamic Republic of