Determining the effectiveness of an intervention program to improve sexual competence in young adult women about to get married
Design
The study is a controlled clinical trial, with parallel groups,double-blind, randomized, phase II study on 35 women about to get married. The allocation of samples to the control and intervention groups will be done by simple randomization. A random number table will be used.
Settings and conduct
The sexual competence program developed will be implemented for 35 young women on the verge of marriage who refer to the Ibn Sina and Gol Yas premarital counseling centers in Isfahan. A researcher-made sexual competence questionnaire will collect data in the intervention and control groups before, immediately, and 2 months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Young adult women between the ages of 18 and 25.
Exclusion criterion: unwillingness to participate in the study.
Intervention groups
The intervention and control groups will consist of women aged 18-25 who are about to get married. The sexual competence training program will be implemented in 4 sessions in a specific sequence for the intervention group. The control group will receive the usual training during marriage in government pre-marriage classes. At the end of the study, the training provided to the intervention group will also be implemented for the control group.
Main outcome variables
Outcome variable: Sexual competence of young adult women about to get married.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231103059937N1
Registration date:2025-08-22, 1404/05/31
Registration timing:registered_while_recruiting
Last update:2025-08-22, 1404/05/31
Update count:0
Registration date
2025-08-22, 1404/05/31
Registrant information
Name
Zahra Sadat Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3361 3598
Email address
mousavi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-11, 1404/04/20
Expected recruitment end date
2025-10-12, 1404/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of an intervention program to improve the sexual competence of young adult women about to get married
Public title
Investigating the effectiveness of the intervention program to improve the sexual competence of young adult women about to get married
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in research
Age between 18 and 25 years
Iranian nationality
Exclusion criteria:
Unwillingness to continue cooperation in every stage of the research
Incomplete questionnaires
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, the allocation of samples in two control and intervention groups will be done by a simple randomization method. The unit of randomization is individual and people will be divided into two groups using a table of random numbers. In this way, first, all the group members are numbered from 1 to 70. Then the researcher, with his eyes closed, places the pointer on the numbers of the random table and moves from the same number in the corresponding row to the right. Even numbers will be assigned to the control group and odd numbers to the intervention group. Also, for concealment, central randomization will be used. This way, a random sequence is given to a specific person, and sampling is done. Based on the order in which the participants entered the study, the researcher communicated with the relevant person by phone and asked about the random allocation of the participants to the intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher will prepare the questionnaire. Then the questions will be provided to the teacher of sexual competence classes. The teacher will hold the class, and the questionnaires will be completed after the class without the researcher's knowledge. The instructor will not be at fault in allocating samples and analyzing data. Next, the lecturer puts the supplementary questionnaires in the envelope and gives them to the researcher. At the end, the researcher will give the questionnaires to the outcome assessor without mentioning the names of the control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Nursing, Management and Rehabilitation - Isfahan University of Medical Sciences (Research
Street address
Soffe Terminal. Beginning of the National Highway. Zeytoun Residential Complex 1
City
Isfahan
Province
Isfehan
Postal code
84137-33993
Approval date
2023-12-25, 1402/10/04
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.160
Health conditions studied
1
Description of health condition studied
Examining the level of sexual competence in young adult women (18-25 years old)
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of sexual competence in the researcher-made questionnaire
Timepoint
The sexual competence score in young adult women will be measured before, immediately and 2 months after the implementation of the sexual competence promotion program
Method of measurement
Questionnaire made by the researcher
2
Description
information of sexual competence
Timepoint
before, immediately and 2 months after the intervention
Method of measurement
Questionnaire
3
Description
motivation for Acquisition of sexual competence
Timepoint
before, immediately and 2 months after the intervention
Method of measurement
Questionnaire
4
Description
behavioral skills for for Acquisition of sexual competence
Timepoint
before, immediately and 2 months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, the intervention will include training in a sexual competence enhancement program for young adult women, which was obtained from a combination of a qualitative study and literature review, and a panel of experts in the first phase of the study. The content of the first training session will include sexual competence, its positive and negative consequences, the second session will correct false sexual beliefs and expectations, the third session will teach safe sex and discuss and evaluate people's beliefs and attitudes regarding the negative effects of unsafe sexual behavior on health, and the fourth session will teach assertiveness skills, saying no, and effective conversation. 4 training sessions will be conducted in a weekly sequence after the intervention group is called to the training location. Before the start of the first session, a pre-test will be taken from the samples. The duration of the classes will be 90 minutes, of which the first 60 minutes will be related to presenting educational content using lecture and question-and-answer methods, and the last 30 minutes will be dedicated to answering the samples' questions. At the end of the 4 sessions and also 2 months later, a post-test will be taken.
Category
Lifestyle
2
Description
Control Group: In this study, the control group will receive 2-hour sexual education that is routinely provided to all couples in premarital centers. This education includes education on contraception, abortion, and sexual anatomy and physiology. Pre-test and post-test will be administered before and after the premarital center educational classes. After completing the study and completing the questionnaire, the sexual competence enhancement program will also be implemented for the control group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina premarital counseling centers in Isfahan city
Full name of responsible person
Zahra Sadat Mousavi
Street address
Soffe Terminal. Beginning of the National Highway. Zeytoun Residential Complex 1
City
Isfahan
Province
Isfehan
Postal code
84137-33993
Phone
Email
mousavi@nm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Soffe Terminal. Beginning of the National Highway. Zeytoun Residential Complex 1
City
Isfahan
Province
Isfehan
Postal code
84137-33993
Phone
+98 31 3668 0048
Email
Mousavi@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
zahra sadat mousavi
Position
PhD student at the Ministry of Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Soffe Terminal. Beginning of the National Highway. Zeytoun Residential Complex 1
City
Isfahan
Province
Isfehan
Postal code
84137-33993
Phone
+98 31 3361 3598
Email
Mousavi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Sadat Mousavi
Position
PhD student at the Ministry of Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Soffe Terminal. Beginning of the National Highway. Zeytoun Residential Complex 1
City
Isfahan
Province
Isfehan
Postal code
84137-33993
Phone
+98 31 3361 3598
Email
Mousavi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Sadat Mousavi
Position
PhD student at the Ministry of Health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Soffe Terminal, beginning of the national highway, Zeytoun 1 residential complex
City
Isfahan
Province
Isfehan
Postal code
84137-33993
Phone
+98 31 3361 3598
Email
Mousavi@nm.mui.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