Protocol summary

Summary
The current study aims to determine the effect of teaching the "good-enough sex model" on sexual intimacy and sexual satisfaction in menopausal and non-menopausal women who have referred to the Shahid Beheshti Medical University health centers. This research is quasi-experimental, in such a way that a list of the health centers relevant to the Shahid Beheshti Medical University is provided first. Three health centers will be randomly selected then; in these three centers, the samples (50 menopausal and 50 non-menopausal women) will be selected continuously based on the entry criteria to join the research. The population under study must be healthy Iranians free from any chronic illnesses, having had a natural menopause, and living within the first ten years of menopause; besides, the non-menopausal women mustn't be during their pregnancy or breastfeeding. teaching this pattern and help an increase in intimacy and the sexual satisfaction of women. After obtaining written consent sexual intimacy and sexual satisfaction will be measured and then for each group separately three 60-minute sessions spaced 10 days on the base of " good enough sex model" is organized, again, two weeks after the last session sexual intimacy and sexual satisfaction will be checked. The primary outcome in this study is sexual intimacy and sexual satisfaction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016072120854N4
Registration date: 2017-03-12, 1395/12/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-12, 1395/12/22
Registrant information
Name
Hedyeh Riazi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 912 386 5612
Email address
h.riazi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Privately funded.
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of "good-enough sex model" on sexual intimacy and sexual satisfaction in menopausal and non-menopausal women.
Public title
Study of the effect of "good-enough sex model" on sexual intimacy and sexual satisfaction in menopausal and non-menopausal women.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Being Iranian; Willing to participate in the study and be available during the next month; Living with their spouse during the study; Have a minimum education (reading and writing); Neither wife nor husband mustn't have experienced any serious tension during the study; Having a natural menopause; Being in the first ten years of their menopause; Not being in the period of pregnancy or breastfeeding. Exclusion criteria Women who may get pregnant during the study; Women who do not have desire to continue their cooperation with the researcher; Women who would be unable to participate in all the three education sessions.
Age
From 20 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is designed to assess the sexual intimacy and sexual satisfaction before and after education in the study population.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Vali Asr Avenue, cross of Niyayesh, in front of Shahid Rajai Hospital, Nursing and Midwifery school
City
Tehran
Postal code
1985717443
Approval date
2016-01-19, 1394/10/29
Ethics committee reference number
IR.SBMU.PHNM.1394.264

Health conditions studied

1

Description of health condition studied
sex counselling
ICD-10 code
Z70.1
ICD-10 code description
Counselling related to sexual attitude, behaviour and orientation

Primary outcomes

1

Description
Sexual intimacy
Timepoint
Before intervention and 2 weeks after the end of intervention
Method of measurement
Questionnaire of sexual intimacy

2

Description
Sexual satisfaction
Timepoint
Before intervention and 2 weeks after the end of intervention
Method of measurement
Questionnaire of sexual satisfaction

Secondary outcomes

empty

Intervention groups

1

Description
Intervention is on the base of education. Education is based on "good enough sex model" for menopausal and non-menopausal women in three sessions. This strategy is separately applied for each group of them. Classes will be held with10 days interval as well as each session is 1 hour.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health centers relevant to the Shahid Beheshti University of Medical sciences
Full name of responsible person
Neda shokri
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
Valieasr av. cross Niyayesh
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Shokri
Position
Ms student of midwifery
Other areas of specialty/work
Street address
Valiasr Av., cross Niyayesh
City
Tehran
Postal code
Phone
+98 912 489 8673
Fax
Email
neda.sh990@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hedyeh Riazi
Position
Ph.D in Reproductive Health/Academic member of Midwifery and Reproductive Health Department
Other areas of specialty/work
Street address
Valiasr Av., cross Niyayesh
City
Tehran
Postal code
Phone
+98 21 8820 2512
Fax
Email
h.riazi@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Neda Shokri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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