The effect of integrated consultation based on EX-PLISSIT model on female orgasm disorder
Design
This study is a non-blind randomized clinical trial with a control group. The estimated sample size is 60 individuals divided into two intervention and control groups with simple random allocation.
Settings and conduct
The research environment is Arash Women's Hospital of Tehran University of Medical Sciences. Eligible women will be divided into intervention and control groups after obtaining informed consent by simple randomization. The intervention group will receive integrated sexual counseling for three weeks using the EX-PLISSIT model. The control group will not receive any intervention during the study. The Female orgasm scale will be completed for both groups before, 4, and 8 weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Married women with
Being in the permanent and monogamous marital relationship
Having at least level of reading and writing literacy
Criteria for not the entrance to the study:
Having sexual dysfunction being in the treatment process
Addiction to narcotic drugs and alcohol
Her husband has sexual dysfunction
A positive history of unpleasant psychological experiences in the past six months
Being in the pregnancy, lactation, and menopause period
Having psychological and physical well-known chronic disease that affects sexual function
Using drugs that affect sexual function
Exclusion criteria:
Not willing to continue of the study
Absent in the one or more than Therapeutique sessions.
Intervention groups
The intervention group will receive integrative sexual counseling based on the EX-PLISSIT model for three weekly sessions. The control group will no intervention during the study but after that, based on their willing the researcher will educate them.
Main outcome variables
Orgasmic disorder
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N9
Registration date:2019-11-25, 1398/09/04
Registration timing:registered_while_recruiting
Last update:2019-11-25, 1398/09/04
Update count:0
Registration date
2019-11-25, 1398/09/04
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
2019-10-21, 1398/07/29
Expected recruitment end date
2020-03-09, 1398/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of integrative counseling based on EX-PLISIT model in women with female orgasmic disorder (FOD)
Public title
The effect of integrative counseling based on EX-PLISIT model in women with female orgasmic disorder (FOD)
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having reading and writing literacy.
Age of 18-45 years
Having a live husband
Married
Sexually active
Not having other sexual disorders
Exclusion criteria:
Having or positive history of well-known psycho-somatic diseases
Using sexually-suppressive drugs
Having marital and interpersonal relationships satisfaction
Substance abuse
Unwillingness to participate in any of the stages of the research and not attending more than one of the intervention sessions
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individuals will be allocate by simple random method in two groups; intervention and control. It is a technique that chooses individuals for intervention and control groups entirely by chance with no regard to the will of researchers or patients' condition and preference. In this study, simple random allocation will be done by tossing a coin.
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
Ethics committee of Tehran University of Medical Sciences
Street address
No. 226, Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2940
Health conditions studied
1
Description of health condition studied
Female orgasmic disorder
ICD-10 code
F52.31
ICD-10 code description
Female orgasmic disorder
Primary outcomes
1
Description
Female orgasmic disorder
Timepoint
Before the intervention, 4, 8 weeks after the intervention
Method of measurement
Female orgasm scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive individualized integrative sexual counseling by using the EX-PLISSIT model through three sessions during 45 to 60 minutes. The female orgasm scale will be complete before, 4 and 8 weeks after the intervention by sample of intervention group.
Category
Behavior
2
Description
Control group: The control group will not be receive the intervention. The female orgasm scale will be complete before, 4 and 8 weeks after the intervention by sample of control group.
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
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
Person responsible for scientific 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, Assistant Professor of Reproductive Heaith Departm
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Nosrat St., 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
Data of the study would be available after unrecognizable process of participants
When the data will become available and for how long
6 months after publications of findings
To whom data/document is available
Data of this research would be available for academic researchers
Under which criteria data/document could be used
Data of this study would be available for same research
From where data/document is obtainable
Dr. Raziyeh Maasoumi
What processes are involved for a request to access data/document
Sending a request by email attendance to the office of corresponding of project presentation the reasons for similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in office of corresponding author