Sexual Dysfunction, Takotsubo Cardiomyopathy
Conditions
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.
Interventions
BEHAVIORALMindfulness-Based Sex Therapy
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.
OTHERTreatment as usual
Routine discharge counseling
Sponsors
Qazvin University Of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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). |
| 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 |
| 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). |
| 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). |
| 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. |
| 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 |
Countries
Iran
Contacts
Primary ContactAmir Pakpour, Ph.D.
Outcome results
None listed