Protocol summary

Study aim
Comparing the effect of multidimensional sex education with routine classes of education during marriage on the knowledge and sexual attitude in premarital couples
Design
A clinical trial with a control group, with parallel groups, one-sided blind, randomized, assigning samples to groups using the randomized block method.
Settings and conduct
Refer to the health center of Kashan city that conducts marriage classes, identify eligible people, ask eligible people to participate in the study if they wish to complete the questionnaires, divide the patients into two control and intervention groups in a randomized block manner, complete Questionnaires by both groups, implementation of training in Skyroom, the statistical analyst has no knowledge of intervention and control subjects.
Participants/Inclusion and exclusion criteria
First marriage, being Iranian, having a smart phone, being literate, consenting to participate in the study / not having general health (according to the GHQ questionnaire), couples who previously attended sex education classes except the class of this center, temporary marriage With another spouse, cohabitation begins immediately after marriage
Intervention groups
After obtaining informed consent from the couple and completing the pre-test, the intervention sessions will be carried out in 4 sessions of 45-60 minutes with an interval of one week. It will be next month. In the control group, after completing the study, during a PowerPoint session containing educational materials on sexual, religious and psychological dimensions, they will be provided.
Main outcome variables
Sexual knowledge and attitude in premarital couples

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20161126031117N14
Registration date: 2023-08-12, 1402/05/21
Registration timing: prospective

Last update: 2023-08-12, 1402/05/21
Update count: 0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Multidimensional Sex Education with Routine Classes of Education during Marriage on the Sexual Knowledge and Attitude in Premarital Couples
Public title
The effect of Multidimensional Sex Education on the Sexual Knowledge and Attitude in Premarital Couples
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
First Marriage Being Iranian Having a Smartphone Being Literate in Reading and Writing Consent to Participate in the Study
Exclusion criteria:
Lack of General Health (according to the GHQ questionnaire) Couples who previously Attended Sex Education Classes Except the Class of this Center Temporary Marriage with Another Spouse Starting Cohabitation Immediately after Marriage
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 88
More than 1 sample in each individual
Number of samples in each individual: 2
1 couple
Randomization (investigator's opinion)
Randomized
Randomization description
Random block method will be used to assign samples to groups. In this method, couples will be considered as blocks. Blocks will be considered in the form of 4 (in each block 2 pairs for each group) and finally 22 different blocks will be used to assign 44 pairs to two groups. The selection of the block type will be determined by the software 2 Random Allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor: Due to being nameless Questionnaires (assignment of a code), the outcome assessor does not know about the allocation groups of the participants. The statistician also does not know about the groups because the groups are named with A and B codes.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, multidimensional intervention is defined.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem square / Moalem street
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.MAZUMS.REC.1402.148

Health conditions studied

1

Description of health condition studied
Sexual knowledge and attitude in premarital couples
ICD-10 code
Z70
ICD-10 code description
Counseling related to sexual attitude, behavior and orientation

Primary outcomes

1

Description
Sexual knowledge in premarital couples
Timepoint
Determining the sexual knowledge of couples about to get married before the intervention, after and three months after the intervention
Method of measurement
Snell et al.'s sexual awareness questionnaire (1991)

Secondary outcomes

1

Description
sexual attitude in premarital couples
Timepoint
Determining the sexual attitude of couples about to get married before the intervention, after and three months after the intervention
Method of measurement
Ezgoli et al. sexual attitude questionnaire (1379)

Intervention groups

1

Description
Intervention group: Couples intervention sessions will be conducted after completing the pre-test for 45-60 minutes and in 4 sessions with an interval of one week. During the 3 months, the couple will be contacted once a week to follow up and make sure they have completed their homework, whether they have started living together, and whether they have attended the training class or not. Immediately after the completion of the post-test intervention sessions and the follow-up and re-evaluation of the two groups in terms of sexual knowledge and attitudes, it will be 3 months later.
Category
Behavior

2

Description
Control group: The control group receive routine training in pre-marital education classes. After completing the study, during a PowerPoint session containing educational materials about the knowledge and sexual attitude of the couples about to get married, they will be provided to them.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Golabchi Kashan Health Center
Full name of responsible person
Dr. Soghra Khani
Street address
Darb Hoz / Imam Khomeini Ave
City
Kashan
Province
Isfehan
Postal code
4816715793
Phone
+98 31 5544 7275
Email
khanisog343@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Mehdi Abbastabar
Street address
Moallem Square_Moallem Street_Research Center of Mazandaran University of Medical ScienceS
City
Sari
Province
Mazandaran
Postal code
4816717887
Phone
+98 11 8303 3339
Fax
+98 11 8303 3339
Email
mabastabar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran University of Medical Science
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
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Seyri
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rahmani street / Shahed street
City
Kashan
Province
Isfehan
Postal code
8731746758
Phone
0098 31 5544294
Email
fateme.seyri96@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Soghra Khani
Position
PhD / Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Vesal street_Amirmazandarani Boulevard_Sari_Mazandaran Province_Iran
City
Sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 8918
Email
khanisog343@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fateme Seyri
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Rahmani street / Shahed street
City
Kashan
Province
Isfehan
Postal code
8731746758
Phone
+98 31 5554 4294
Email
fateme.seyri96@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information related to the research is shared with the aim of keeping the names of the people and keeping their identities confidential and complying with the 31 codes of ethics.
When the data will become available and for how long
Since 2024
To whom data/document is available
All researchers and those interested in research
Under which criteria data/document could be used
To conduct review and supplementary research and to use educational classes during marriage
From where data/document is obtainable
In order to receive data or documents, the responsible author can be reached by e-mail khanisog343@gmail.com and the e-mail of the counseling student in midwifery can be reached by e-mail fateme.seyri96@gmail.com. If the article is published, you can refer to it according to the journal's address.
What processes are involved for a request to access data/document
First, you should send an email to the responsible author of the article and make your request, and if the responsible author and the research team deem it appropriate, the documents and files will be provided in a short period of time.
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