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Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

Primary Purpose

Takotsubo Cardiomyopathy, Sexual Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Mindfulness-Based Sex Therapy
Treatment as usual
Sponsored by
Qazvin University Of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takotsubo Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Booali Sina HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

patient and partner

patient ,partner and cardiac rehabilitation team

Treatment as usual

Arm Description

Outcomes

Primary Outcome Measures

Sexual functioning
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
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
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

Secondary Outcome Measures

Mindfulness
Sexual Five-Facet Mindfulness Questionnaire (FFMQ-S) is used to assess mindfulness in the context of sexual encounters
Marital satisfaction
The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
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
Rumination
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
Persons' emotions in response to stressful life events is measured using he Cognitive Emotion Regulation Questionnaire short version (CERQ-short).
quality of life
HRQoL is measured using Short Form health survey (SF-12).
Social Support
Social support will be assessed by the ENRICHD Social Support Inventory (ESSI ).
Sense of Coherence
Sense of coherence will be measured using the Antonovsky's 13-item sense of coherence scale (SOC-13).

Full Information

First Posted
December 9, 2017
Last Updated
December 9, 2017
Sponsor
Qazvin University Of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03372577
Brief Title
Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy
Official Title
Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy Among Iranian Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
July 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qazvin University Of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takotsubo Cardiomyopathy, Sexual Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patient and partner
Arm Type
Experimental
Arm Title
patient ,partner and cardiac rehabilitation team
Arm Type
Experimental
Arm Title
Treatment as usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Sex Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
Routine discharge counseling
Primary Outcome Measure Information:
Title
Sexual functioning
Description
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
Title
Sexual Distress
Description
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
Title
Intimacy
Description
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
Secondary Outcome Measure Information:
Title
Mindfulness
Description
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
Title
Marital satisfaction
Description
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
Title
Psychological distress
Description
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
Title
Rumination
Description
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
Title
Emotion regulation
Description
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
Title
quality of life
Description
HRQoL is measured using Short Form health survey (SF-12).
Time Frame
changes from baseline, 1 Months ,6 months, 12 months and 18 months
Title
Social Support
Description
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
Title
Sense of Coherence
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Pakpour, Ph.D.
Phone
+98-28-33239259
Email
pakpour_amir@yahoo.com
Facility Information:
Facility Name
Booali Sina Hospital
City
Qazvin
ZIP/Postal Code
3419759811
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Pakpour, Ph.D.
Phone
+98-28-33239259
Email
pakpour_amir@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Mindfulness-based Sex Therapy on Patients With Takotsubo Cardiomyopathy

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