View older revisions Content changed at 2021-02-04, 1399/11/16

Protocol summary

Study aim
Assessing the effect of sexual health education package on the sexual life of employed women
Design
A randomized controlled clinical trial with parallel groups, without blinding, was performed on 70 employed women. The random number table of Rand Company was used for randomization.
Settings and conduct
The present study will be conducted as a clinical trial with the participation of 70 women working in the municipality of District 10 of Tehran in 1399. Employed women will be randomly assigned to intervention and control groups. In the intervention group, the sexual health training package (prepared by the research team) will be done in 8 sessions in 8 weeks as a group to women working in the municipality of District 10 of Tehran. In the control group, no action will be taken.
Participants/Inclusion and exclusion criteria
Major conditions for entering the study before randomization: married employed women living in Tehran, having age 20 to 45, having literacy in Persian, no known underlying disease, no history of psychiatric interventions, no stressful event during the past month, no history of pelvic surgery, no uterine prolapse, cystocele, rectocele and genital infections, no history of depression and anxiety, no consumption of alcohol, drugs and cigarettes (based on self-expression of the samples) and having desire to participate in the study. Major conditions for not entering the study before randomization: Do not attend training sessions (at least two absentee sessions)
Intervention groups
In the intervention group, the sexual health training package (prepared by the research team) will be done in 8 sessions in 8 weeks as a group to women working in the municipality of District 10 of Tehran. In the control group, no action will be taken.
Main outcome variables
Promoting the sexual health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200927048854N1
Registration date: 2020-10-29, 1399/08/08
Registration timing: registered_while_recruiting

Last update: 2021-02-04, 1399/11/16
Update count: 1
Registration date
2020-10-29, 1399/08/08
Registrant information
Name
khadige abadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4495 8982
Email address
kh_abadian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual health education package on the sexual life of working women
Public title
Investigating the effect of sexual health education on sexual life
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married employed women living in Tehran having age 20 to 45 having literacy in Persian Desire to participate in the study
Exclusion criteria:
known underlying disease history of psychiatric interventions stressful events during the past month history of pelvic surgery uterine prolapse, cystocele, rectocele and genital infections history of depression and anxiety, Consumption of alcohol, drugs and cigarettes (based on self-expression of the samples)
Age
From 20 years old to 45 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
Randomization is generated by random or random number tables and by computers that randomly set numbers. One of these programs is the Rand Company Random Number Table. To use a table of random numbers, the researcher must first define the framework of his / her statistical community; That is, determine the exact number of people in the community and give them a code or number, respectively. Because the total number of people in the community is 70, the codes and numbers assigned to people in the community will also be double digits, such as 01, 02, 03 And we enter these two-digit hunts into the software, then we randomly start from a point in the table in the direction of a row or column to select sample people from the table. The selection of the point can be done by closing the eyes and placing a finger or the tip of a pen on the table. The movement does not differ in the direction of the row or column, and this is up to the researcher. But according to the type of code digits (two digits) he must select the same number of digits in the row or column direction. It then controls the route numbers. He will inevitably encounter two types of numbers, one of which is smaller than the number of the study population and the other of which is larger than the number of the population. It should only consider and select smaller numbers. The selected number is in fact the individual code of the community that is selected as the sample. This should be continued until a small number can be selected based on the number of sample people (35). After the sample size is completed, the sampling work is completed. The 35 people selected are the intervention group and the rest of the codes are the control group.
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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences,Tehran
City
Tehran
Province
Tehran
Postal code
38698-65178
Approval date
2020-08-23, 1399/06/02
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.200

Health conditions studied

1

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

Primary outcomes

1

Description
Promoting the sexual health of working women
Timepoint
Before, immediately and 4 weeks after the intervention
Method of measurement
Female Sexual Function Index and and Marital Satisfaction Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Training sessions will be held by the researcher for 8 weeks and 8 sessions (each session is 90 minutes) in groups and for women working in the municipality of District 10 of Tehran. The contact numbers will be obtained from the participants and in the virtual group formed by the researcher in WhatsApp software; To better understand the content by employed women, at the beginning of each session, time will be allocated to women for expressing their opinions and questions, as well as questions and answers about the topics discussed in the previous session. "Women's Sexual Function Index" and "Marital Satisfaction Scale" It will be measured simultaneously with the control group before, immediately and 3 weeks after the study.
Category
N/A

2

Description
Control group: In the control group without any educational intervention, "Women's Sexual Function Index" and "Marital Satisfaction Scale" will be measured simultaneously with the intervention group before, immediately and 3 weeks after the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran District 10 Municipality
Full name of responsible person
Zohre Keshavarz
Street address
Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
38698-65178
Phone
+98 21 4495 8982
Email
keshavarzzohre57@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
ِDr Masoumeh Simbar
Street address
Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2512
Email
msimbar@yahoo.com
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Keshavarz
Position
Associate Professor Shahid Beheshti University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Valiasr St. - Niayesh Intersection - Opposite to Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
z.keshavarz@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zohre Keshavarz
Position
Associate Professor Shahid Beheshti University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Valiasr St. - Niayesh Intersection - Opposite to Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2512
Email
z.keshavarz@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Khadige Abadian
Position
PhD in Reproductive Health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Valiasr St. - Niayesh Intersection - Opposite to Shahid Rajaei Heart Hospital - School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 4495 8982
Email
kh_abadiaN@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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