Protocol summary
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Study aim
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Determining the effect of mindfulness-based sex therapy on sexual desire disorder, distress, self-disclosure and sexual function
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Design
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This is a non-blind randomized clinical trial with two groups; intervention and control. Sampling will be done by random allocation using the four-way blocking method.
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Settings and conduct
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The research environment is three selected health-care centers affiliated Tehran University of Medical Sciences. The research population is women in reproductive age referring to these centers. An intervention group will be received sex education, mindfulness exercises, behavioral therapy related to the response to the sexual response cycle, and skills to increase self-control and sexual distress control through lectures, group discussions, CDs, and homework assignments. The control group will not receive an intervention until the end of the study. Evaluation of the effect of training sessions will be conducted before the intervention, immediately, 4 and 12 weeks after the last session.
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Participants/Inclusion and exclusion criteria
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Married women with age of 15-49 years
Being sexually active
High school educated
Not having other sexual disorders except sexual desire disorder
Not pregnant and not being in lactation period
Do not use of drugs that effect sexual desire
Lack of spouse's sexual problems and interpersonal and marital dissatisfaction
Having well-known psycho-somatic diseases
Not willing to participate in any of phases of research or do not attending more than one of the intervention sessions
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Intervention groups
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Intervention group will be received 4-weekly sessions during 90-120 minutes with content based on sex education, mindfulness exercises, and behavioral therapy. The control group will not receive an intervention until the end of the study.
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Main outcome variables
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sexual desire disorder, distress, self-disclosure and sexual function
General information
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Reason for update
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Best Regards
The information related to the present study is part of the master's thesis. Due to the time constraints of researching in the form of a thesis, it was not possible to perform follow-up at longer intervals. Therefore, only short follow-ups were considered in the thesis and routine follow-ups with longer intervals of hypoactive sexual desire disorder were approved and continued as a research project in accordance with the thesis. Therefore, to report rutin follow-ups with longer intervals in the form of a scientific article, we request to update and record the approved follow-ups of the research project in accordance with the thesis.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160808029255N4
Registration date:
2018-09-17, 1397/06/26
Registration timing:
prospective
Last update:
2021-06-15, 1400/03/25
Update count:
1
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Registration date
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2018-09-17, 1397/06/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-05-15, 1397/02/25
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Expected recruitment end date
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2018-12-16, 1397/09/25
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Actual recruitment start date
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2018-09-19, 1397/06/28
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Actual recruitment end date
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2019-03-19, 1397/12/28
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Trial completion date
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2019-08-06, 1398/05/15
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Scientific title
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The effect of mindfulness-based sex therapy on female sexual desire disorder, distress self-disclosure and sexual function
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Public title
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The effect of mindfulness-based sex therapy on female sexual desire disorder, distress self-disclosure and sexual function
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 15-49 years
have been married
being sexually active
having alive spouse
not being pregnant
not being in lactation period
do not use contraceptive drugs that has an effect on sexual desire
lack of spouse's sexual dysfunction
having at least high school education
having marital and interpersonal relationships satisfaction
not having other sexual disorders except sexual desire disorder
Exclusion criteria:
having or positive history of well-known psycho-somatic diseases that interfere with marital relationships daily activities
using sexually-suppressive drugs (such as low blood pressure, H2 blockers, Antihistamines, barbiturates, tri-cyclic antidepressants, SSRIs, etc.)
using alcohol and drugs
taking Simultaneous herbal medicines that affect sexual desire
not willing to participate in any phase of research or not attending in more than one of the intervention sessions
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Age
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From 15 years old to 49 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
Actual sample size reached:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Sampling will be conducted by random allocation using four-way blocking method.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-03-06, 1396/12/15
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Ethics committee reference number
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IR.TUMA.FNM.REC.1396.4743
Health conditions studied
1
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Description of health condition studied
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Sexual desire
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ICD-10 code
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F52.0
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ICD-10 code description
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Hypoactive sexual desire disorder
2
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Description of health condition studied
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sexual disstress
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ICD-10 code
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F52.8
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ICD-10 code description
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Other sexual dysfunction, not caused by organic disorder or disease
3
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Description of health condition studied
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Sexual self-discloser
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ICD-10 code
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ICD-10 code description
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4
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Description of health condition studied
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Sexual function
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Sexual desire
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Timepoint
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Before the intervention, immediately, 4 and 12 weeks post-intervention
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Method of measurement
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Persian version of the Holbert Sexuality Questionnaire (HSID)
2
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Description
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Sexual distress
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Timepoint
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Before the intervention, immediately, 4 and 12 weeks post-intervention
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Method of measurement
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Female Sexual Distress Scale- Revised (FSDS-R)
3
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Description
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sexual self-disclosure
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Timepoint
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Before the intervention, immediately, 4 and 12 weeks post-intervention
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Method of measurement
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Researcher-made questionnaire
4
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Description
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sexual function
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Timepoint
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Before the intervention, immediately, 4 and 12 weeks post-intervention
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Method of measurement
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Persian version of Female Sexual Function Index
Intervention groups
1
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Description
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Intervention group: The intervention group will be receive four-weekly sessions for 90 to 120 minutes. intervention including sex education, mind-boggling exercises, behavioral therapy associated with the sexual response cycle, and skills to increase self-control and sexual distress through speech, group discussions, CDs, and homework assignments. In addition, the intervention content in the form of a booklet will be provided to the intervention group. At the end of each session, women have opportunity to talk about their perceptions of intervention and receive their answers of questions.
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Category
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Behavior
2
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Description
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Control group: The control group will not receive an intervention until at the end of the research. After that, based on the ethics of the research and their willingness the sexual counseling service will be presented by the researcher.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Study data after unidentifiable people can be shared
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When the data will become available and for how long
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six months after publication of findings
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To whom data/document is available
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The data will be available to researchers working in academic and academic institutions
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Under which criteria data/document could be used
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The data from this study will be available for similar studies only
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From where data/document is obtainable
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dr Raziyeh Masoomi:email:r_masoumi@sina.tums.ac.ir
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What processes are involved for a request to access data/document
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Initial correspondence by email, on-site visit, and presentation of a proposal similar to the present study, provide sufficient evidence for the similarity of its research to the present study, study proposal by the present investigator, decision making and announcement of the result by the investigator to the researcher for access to data Providing the data file for use locally
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Comments
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