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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
It is based on an integration of psychoeducation, sex therapy, and mindfulness-based skills. the intervention will be delivered by a group of facilitators on a group based weekly.
Routine discharge counseling
Booali Sina Hospital
Qazvin, Iran
RECRUITINGSexual functioning
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Sexual Distress
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
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Intimacy
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
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Mindfulness
Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Marital satisfaction
The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Psychological distress
Hospital Anxiety and Depression Scale (HADS) is a brief self-administrated tool to assess psychological distress in patients as well as general populations
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Rumination
Rumination is measured using Ruminative Thought Style Questionnaire (RTS). The RTS contains 20 items describing positive, negative and neutral facets of global rumination
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Emotion regulation
Persons' emotions in response to stressful life events is measured using he Cognitive Emotion Regulation Questionnaire short version (CERQ-short).
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
quality of life
HRQoL is measured using Short Form health survey (SF-12).
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Social Support
Social support will be assessed by the ENRICHD Social Support Inventory (ESSI ).
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
Sense of Coherence
Sense of coherence will be measured using the Antonovsky's 13-item sense of coherence scale (SOC-13).
Time frame: changes from baseline, 1 Months ,6 months, 12 months and 18 months
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