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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient and partner | Experimental |
| |
| patient ,partner and cardiac rehabilitation team | Experimental |
| |
| Treatment as usual | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Sex Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual functioning | Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI) | 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 | 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 | changes from baseline, 1 Months ,6 months, 12 months and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mindfulness | Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters | changes from baseline, 1 Months ,6 months, 12 months and 18 months |
| Marital satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir Pakpour, Ph.D. | Contact | +98-28-33239259 | pakpour_amir@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Booali Sina Hospital | Recruiting | Qazvin | 3419759811 | Iran |
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| ID | Term |
|---|---|
| D054549 | Takotsubo Cardiomyopathy |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018487 | Ventricular Dysfunction, Left |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Other | Routine discharge counseling |
|
The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
| 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 | 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 | 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). | 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). | 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 ). | 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). | changes from baseline, 1 Months ,6 months, 12 months and 18 months |
| D018754 |
| Ventricular Dysfunction |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |