An interventional study of Mindfulness-Based Sex Therapy and Treatment as usual in Takotsubo Cardiomyopathy and Sexual Dysfunction, sponsored by Qazvin University Of Medical Sciences. Status unknown at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by Qazvin University Of Medical Sciences · Not applicable, Interventional, and Treatment
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.
63 studies on the registry are indexed under Takotsubo Cardiomyopathy; 26 are open to participants now.
This study's planned enrollment of 450 is above the median of 65 across 24 interventional studies indexed under Takotsubo Cardiomyopathy.
Browse Takotsubo Cardiomyopathy studies →Qazvin University Of Medical Sciences is the lead sponsor of 34 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Behavioral: Mindfulness-Based Sex Therapy
Behavioral: Mindfulness-Based Sex Therapy
Other: Treatment as usual
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
Sexual 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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2017 (actual). Primary completion is estimated for Dec 2018, 12 months after the start.
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This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Qazvin University Of Medical Sciences