Determining the effect of mindfulness-based sex therapy on sexual desire disorder, distress, self-disclosure and sexual function
Design
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.
Settings and conduct
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 during 4 and 8 weeks after the last session.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
sexual desire disorder, distress, self-disclosure and sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N4
Registration date:2018-09-17, 1397/06/26
Registration timing:registered_while_recruiting
Last update:2018-09-17, 1397/06/26
Update count:1
Registration date
2018-09-17, 1397/06/26
Registrant information
Name
Raziyeh Maasoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
r_masoumi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-15, 1397/02/25
Expected recruitment end date
2018-12-16, 1397/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mindfulness-based sex therapy on female sexual desire disorder, distress self-disclosure and sexual function
Public title
The effect of mindfulness-based sex therapy on female sexual desire disorder, distress self-disclosure and sexual function
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be conducted by random allocation using four-way blocking method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of the Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,Ghods St
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-03-06, 1396/12/15
Ethics committee reference number
IR.TUMA.FNM.REC.1396.4743
Health conditions studied
1
Description of health condition studied
Sexual desire
ICD-10 code
F52.0
ICD-10 code description
Hypoactive sexual desire disorder
2
Description of health condition studied
sexual disstress
ICD-10 code
F52.8
ICD-10 code description
Other sexual dysfunction, not caused by organic disorder or disease
3
Description of health condition studied
Sexual self-discloser
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Sexual function
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual desire
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Persian version of the Holbert Sexuality Questionnaire (HSID)
2
Description
Sexual distress
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Female Sexual Distress Scale- Revised (FSDS-R)
3
Description
sexual self-disclosure
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Researcher-made questionnaire
4
Description
sexual function
Timepoint
Before the intervention, 4, 8 and 12 weeks after the intervention
Method of measurement
Persian version of Female Sexual Function Index
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Behavior
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farmanfarmaian Health care center
Full name of responsible person
Dr Raziyeh Maasoumi
Street address
South Kargar st- East Azerbaijan st - not reaching Roshdiyeh crossroad - opposite the Meli Bank
City
Tehran
Province
Tehran
Postal code
87159/81151
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
2
Recruitment center
Name of recruitment center
Akbarabad Health Center
Full name of responsible person
Dr Raziyeh Maasoumi
Street address
Nawab st. Western Mahbob mogaz st
City
Tehran
Province
Tehran
Postal code
87159/81151
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Vahedi Health Center
Full name of responsible person
Dr Raziyeh Maasoumi
Street address
yakhchy abad,- next to the women's organization
City
Tehran
Province
Tehran
Postal code
87159/81151
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Street address
East Nosrat., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Pos.doc of Sexology,PhD of Reproductive Health, Assisstent Professor of Reproductive Heaith Departm
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery,Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tima.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
َAssisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
East Nosrat.,Towhid Sq,.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tima.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
East Nosrat., Towhid Sq,.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tima.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Study data after unidentifiable people can be shared
When the data will become available and for how long
six months after publication of findings
To whom data/document is available
The data will be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
The data from this study will be available for similar studies only
From where data/document is obtainable
dr Raziyeh Masoomi:email:r_masoumi@sina.tums.ac.ir
What processes are involved for a request to access data/document
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