The effect of designed educational intervention on women's sexual performance
Design
The clinical trial has two intervention groups and one control group, which will be randomly selected from the health centers of Zabul University of Medical Sciences.
The sample size is 49 for each group and 98 for the two groups, which is considered to be 110 people in total.
Settings and conduct
The research environment in this study was the health care centers of marginalized areas under the supervision of Zabul University of Medical Sciences, so that 4 out of ten marginalized areas were randomly selected.
Then, a health center was randomly selected from each region in a one-stage cluster.
Then, in each center, sampling will be done in an accessible and continuous manner.
In this way, all marginalized women who are eligible to enter the study were included in the study after providing full explanations about the purpose of the study and obtaining informed written consent.
And finally, they were randomly assigned to two intervention and control groups.
Participants/Inclusion and exclusion criteria
The conditions for entering the study included married women aged 15-49, non-lactating, non-pregnant, with no history of any physical or mental illness and living in marginalized areas.
Exclusion criteria include the individual's unwillingness to continue participating in the study, the occurrence of pregnancy during the study period
Intervention groups
consisting of an intervention group (sexual education about improving sexual performance) and a control group
Main outcome variables
Improvement of sexual performance after completion of educational intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231121060133N1
Registration date:2023-12-01, 1402/09/10
Registration timing:registered_while_recruiting
Last update:2023-12-01, 1402/09/10
Update count:1
Registration date
2023-12-01, 1402/09/10
Registrant information
Name
Maryam Koochakzai
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3342 3792
Email address
m61.parsa@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention on the sexual performance of marginalized women in eastern Iran
Public title
Investigating the effect of educational intervention on the sexual performance of women living in the marginal areas of eastern Iran
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1-Women aged 15-49
2- Married and currently living with his wife
3- He should not have acute communication problems with his wife
4- Not during pregnancy and breastfeeding
5- Be a resident of marginal areas
6- Not suffering from a known physical or mental illness
7- Not suffering from severe depression (score less than 29 in the Beck BID-II questionnaire)
8- Having sexual activity in the past month
9-Sexual function disorder in the person (female sexual function score of 26 or less (FSFI).
10-According to the woman's statement, her husband does not have any sexual dysfunction.
11- It is possible to reach the person within the next 4 months
12- He has not participated in any written training course related to marital problems
Exclusion criteria:
1- The individual's unwillingness to continue attending the study
2- Occurrence of pregnancy during the study period
3- Occurrence of severe family disputes with spouse during the study period
4- The occurrence of unfortunate and stressful events during the study period (such as death of parents, death of children, etc.)
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
First, the participants will be divided into two intervention and comparison groups by random block method.
In this way, all possible modes of placing the letters A and B in blocks of four will be considered, which include a total of 6 modes.
These 6 modes are numbered from 1 to 6, and the number of blocks of 4 needed will be determined based on the number of studied samples. Then, according to the required number of blocks, we will line up a random number based on the table of random numbers one after the other; Of course, numbers above 6 will not be considered.
Finally, based on the order of the numbers extracted from the table, the blocks related to each number will be listed in order, and when the samples enter the study, each person will acquire a specific letter according to the obtained order.
For example, according to the order (AABB/ABAB), the 5th person will be in group A.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the intervention, it is not possible to blind the researcher and the participant.
In order to blind the outcome assessor, the questionnaires will be completed by the researcher's assistant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-08-17, 1401/05/26
Ethics committee reference number
( IR. TUMS.FNM. REC.1401.067)
Health conditions studied
1
Description of health condition studied
Educational needs on sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition
Primary outcomes
1
Description
Percentage of people with sexual dysfunction
Timepoint
after completing the study
Method of measurement
FSFI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Sex education programs in this study were implemented in four 60-minute sessions with an interval of one week. And it was presented in the form of lectures, questions and answers, group discussions and pamphlets. In the first week, the program included the introduction of the anatomy and physiology of the female reproductive system and factors affecting the sexual cycle. In the second week, the program focused on sexual dysfunction, helping women try lifestyle changes, and building motivation. The third week, the program was based on communication and negotiation skills for conflict resolution. In the fourth week, the program was to summarize and review the previous materials. At the end of each session, we answered the specific questions of the participants. A post-test was conducted after 8 weeks from the last training session. In case of any questions, the researchers gave the participants a phone number. In this study, the control group only received the routine program of reproductive health education. Evaluation of the effect of training sessions was done 8 weeks after the last training session in the intervention group and 8 weeks after the initial completion of the questionnaire in the control group. At the end of the training package, it was provided to the control group.
Category
Other
2
Description
Control group: Receiving a four-session face-to-face educational intervention on the topic of reproductive health is done according to the routine program of the health center.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers under the supervision of Zabul University of Medical Sciences
Full name of responsible person
Maryam Koochakzai
Street address
NO.6.Mirhoseini Blvd, Zabol Town
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861954959
Phone
+98 54 3342 3792
Email
m61.parsa@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Research and Technology Dept, 6th floor, Central University Organization, corner of Quds St, Keshavarz Bolvar
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.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
Elham Ebrahimi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, EastNusrat St, Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Ebrahimi-308@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, EastNusrat St, Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Ebrahimi-308@yahoo.com
Web page address
http://fnm.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Elham Ebrahimi
Position
Associate professor ل
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nusrat St, Tawheed Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Ebrahimi-308@yahoo.com
Web page address
http://fnm.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Participants data is confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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