Protocol summary
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Study aim
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Assessing the effect of sexual health education package on the sexual life of employed women
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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)
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Intervention groups
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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.
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Main outcome variables
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Promoting the sexual health
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2020-10-29, 1399/08/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-22, 1399/08/01
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Expected recruitment end date
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2020-12-21, 1399/10/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of sexual health education package on the sexual life of working women
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Public title
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Investigating the effect of sexual health education on sexual life
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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)
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-08-23, 1399/06/02
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Ethics committee reference number
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IR.SBMU.PHARMACY.REC.1398.200
Health conditions studied
1
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Description of health condition studied
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sexual health
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Promoting the sexual health of working women
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Timepoint
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Before, immediately and 4 weeks after the intervention
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Method of measurement
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Female Sexual Function Index and and Marital Satisfaction Scale
Intervention groups
1
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Description
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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.
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Category
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N/A
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available