An interventional study of Mindfulness-Based Sex Therapy in Epilepsy and Sexual Dysfunction, sponsored by Qazvin University Of Medical Sciences. Completed at 15 sites in Iran, Islamic Republic of. Open to female participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-01-11.
Sponsored by Qazvin University Of Medical Sciences · Not applicable, Interventional, and Treatment
Female sexual dysfunction (FSD) includes impairments in sexual desire, arousal, orgasm, and genital pain resulting in significant subjective distress. This study is aimed to assess a mindfulness-based intervention for improving sexual functioning among women with epilepsy
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's enrollment of 660 is above the median of 50 across 1,239 interventional studies indexed under Epilepsy.
Browse Epilepsy 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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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients and their partners will receive a weekly Mindfulness-Based Sex Therapy program. The treatments will deliver by a group of facilitators to groups of women consisting of 4-7 women.
Behavioral: Mindfulness-Based Sex Therapy
patients and their partners as well as health care providers will receive a weekly Mindfulness-Based Sex Therapy program. Th treatments will deliver by a group of facilitators to groups of women consisting of 4-7 women.
Behavioral: Mindfulness-Based Sex Therapy
The control group will receive a routine counseling
Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.
Sexual functioning
Sexual functioning is assessed using self-reported measure , female Sexual Function Index (FSFI)
Time frame: changes from baseline, 1 Months and 6 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 and 6 months
sexuality-related distress
The Female Sexual Distress Scale revised version (FSDS-R) is extensively validated and among the most widely used tools to measure sexually related personal distress.
Time frame: changes from baseline, 1 Months and 6 months
Mindfulness for sexual functioning
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 and 6 months
Marital satisfaction
The Maudsley Marital Questionnaire (MMQ) is a 20-item instrument measuring marital satisfaction.
Time frame: changes from baseline, 1 Months and 6 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 and 6 months
Erectile Function
International Index of Erectile Function Questionnaire (IIEF) is a self-reported and multidimensional measure of male's sexual function
Time frame: changes from baseline, 1 Months and 6 months
quality of life
QOLIE-31-P will be used to assess patient's quality of life
Time frame: changes of QOLIE-31-P from baseline, 1 Months and 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Mar 2019, 13 months.
Of 337 non-industry interventional studies with no phase under Epilepsy, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 77. This study's 13 months is below that.
Counting every sponsor, half of 358 studies reached it within 42 months; a quarter within 19 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Qazvin University Of Medical Sciences