Protocol summary

Study aim
Determining the effect of sexual counseling based on the BETTER model on the quality of infertile women's sexual life
Design
The research 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. The estimated sample size is 40 in each group. For preventing data contamination after random allocation, the even days will be considered for the test group and the odd days will be considered for the control group.
Settings and conduct
The research environment is the Infertility Clinic in Shahid Beheshti Hospital and a private gynecological clinic in Kashan, Iran. The research community will be consider all of infertile women who refer to both clinics. In the intervention group, sexual counseling based on the BETTER model will be conducted during four weekly sessions and the control group will not receive until at the end of the intervention.
Participants/Inclusion and exclusion criteria
49-15 years, permanent marriage, at least one year of primary infertility, female infertility, being sexual active, having at least level of reading and writing skills; not having known psychological and physical illnesses that affect sexual function, non-using of drugs that affect sexual function, non-using of sexual counseling before the enroll of the present study
Intervention groups
In the intervention group, an individual counseling session will be conducted by the researcher based on the BETTER model during four sessions. Duration of each session will be 60 to 75 minutes. 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.
Main outcome variables
Sexual function, sexual self-efficacy, sexo-marital satisfaction

General information

Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number: IRCT20160808029255N3
Registration date: 2018-06-05, 1397/03/15
Registration timing: registered_while_recruiting

Last update: 2018-06-05, 1397/03/15
Update count: 0
Registration date
2018-06-05, 1397/03/15
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
2018-04-21, 1397/02/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual counseling based on BETTER model on quality of sexual life in infertile women
Public title
The effect of sexual counseling on quality of sexual life in infertile women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 15-49 years permanent marriage at least one year of primary infertility female infertility being sexual active having at least level of reading and writing skills
Exclusion criteria:
having well-known psychological and physical illnesses and affect sexual function such as diabetes, rheumatoid arthritis, depression , and etc. using drugs that affect sexual function such as anti lipid drugs, cimetidine, digoxin, progesterones, antidepressants using of sexual counseling from psychological services and psychiatry, and etc.
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: 80
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
Ethics committee of Tehran University of Medical Sciences Nursing and Midwifery Care Research Center
Street address
south Nosrat Ave., Towhid Sq., Tehran city
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
IR.TUMS.FNM.REC.1369.4662

Health conditions studied

1

Description of health condition studied
sexual function
ICD-10 code
ICD-10 code description

2

Description of health condition studied
sexual self efficacy
ICD-10 code
ICD-10 code description

3

Description of health condition studied
Sexo-marital satisfaction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The physiological responses that a person shows to excite sexual stimulation involves four stages of sexual desire, sexual stimulation, orgasm and suppression.
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
The Persian version of the Female Sexual Function Index (FSFI) will be applied to evaluate sexual function.

2

Description
Sexual self-efficacy is multidimensional variable and is capable of evaluating itself effectively in achieving effective sexual function and achieving satisfactory and desirable sex.
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
A researcher-made sexual self-efficacy questionnaire will be applied to evaluate sexual self-efficacy

3

Description
Sexo-marital satisfaction is the judgment of each individual about her/his sexual behavior that he considers pleasurable, as well as the individual experience of marriage that can be assessed only by any person in response to her marital satisfaction.
Timepoint
Before the intervention, 4 and 8 weeks after the intervention
Method of measurement
Sexo-marital satisfaction subscale of Women's Sexual Quality of Life Questionnaire (SQOL-F) will be applied to evaluate sexo-marital satisfaction.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will be received individual sexual counseling based on the BETTER model during four sessions. Duration of each session will be 60 to 75 minutes.
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
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid beheshti hospital in the city of Kashan
Full name of responsible person
Dr Raziyeh Masoomi
Street address
Qotbe Ravadi bulvar., Kashan
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
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
Raziye Maasoumi
Street address
East Nosrath., Towid 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
Assisstant Proffesor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.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 Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.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
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
East nosrath Av.Towhid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.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 email: r_masoumi@sina.tums.ac.ir
What processes are involved for a request to access data/document
En 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
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