1)Comparison of the mean score of sexual self-concept
2)Comparison of the mean score of sexually dysfunctional beliefs
Design
This study is a randomized controlled trial with a sample size of 64 people. Assignment of samples with a 1: 1 allocation ratio to the two intervention and control groups will be done by random blocking method (blocks of 4 and 6) .
Settings and conduct
The research setting is premarital counseling centers is in Tabriz. The researcher will refer to premarital counseling centers in Tabriz and for the women who intend to get married, the goals and study method will be fully explained. If they wish to participate in the study and attend counseling sessions, we will be reviewed for entry and exit criteria . If they are eligible, individuals will be selected in an easy or accessible way, and after obtaining informed consent, a questionnaire of demographic-social characteristics, a multifaceted questionnaire of sexual self-concept and a questionnaire of dysfunctional sexual beliefs will be completed through interviews. Then participants will be assigned to the intervention and control groups randomly. For the intervention group, sexual counseling with EX-PLISSIT model will be held and the control group will only participate in premarital counseling programs. Four weeks after the intervention, the post test questionnaires will be completed.Due to the nature of the research, it is not possible to blind the participants and the researcher, and only data collectors and analysts are blind.
Participants/Inclusion and exclusion criteria
-Healthy women on the verge of marriage
- Age 15 years and older
-Have a minimum of secondary education
Intervention groups
For the intervention group, sexual counseling with EX-PLISSIT model individually will be held and the control group will only participate in premarital counseling programs.
Main outcome variables
sexual self-concept
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110922007618N10
Registration date:2020-10-12, 1399/07/21
Registration timing:prospective
Last update:2020-10-12, 1399/07/21
Update count:0
Registration date
2020-10-12, 1399/07/21
Registrant information
Name
Soheila Bani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
banis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-05-20, 1400/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sexual counseling with Ex-PLISSIT model on sexual self-concept of women on the verge of marriage:A Randomised Controlled Trial.
Public title
The effect of sexual counseling on sexual self-concept
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy women on the verge of marriage
Age 15 years and older
Have a minimum of secondary education
Not having any mental illness
Exclusion criteria:
Previous marriage history
A history of current mental health problems or a history of hospitalization in a psychiatric hospital
Physical disability
Age
From 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to the intervention (counselor) and control groups by a non-involved person in the study using random blocking method with the size of four and six blocks with a 1: 1 allocation ratio. In order to hide the allocation (Allocation Concealments), the type of intervention will be written on paper and placed in opaque envelopes and in closed and numbered packages. The envelopes will be opened in the order in which the participants enter the study and the type of group of people will be determined.
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
Vice Chancellor for Research, Tabriz University of Medical Sciences
Street address
Golgasht St. - Tabriz University of Medical Sciences - Central Building No. 2 Floor 3 - Research Deputy
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.TBZMED.REC.1399.386
Health conditions studied
1
Description of health condition studied
sexual self-concept
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Improving sexual self-concept
Timepoint
Before the intervention, 4 weeks after the last intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Improve the score of inefficient sexual beliefs
Timepoint
Before intervention, 4 weeks after intervention
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention Sex counseling session with EX-PLISSIT model for 60-90 minutes and if necessary repeat sessions every one week
Category
Other
2
Description
Control group: The control group will only participate in premarital counseling centers programs.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
maryam nematzadeh
Street address
Tabriz School of Nursing and Midwifery, Shariaty St.
City
Tabriz
Province
East Azarbaijan
Postal code
977-5138947
Phone
+98 41 3553 9161
Email
mari.nematzadehbel@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Golgasht St. - Tabriz University of Medical Sciences - Central Building No 2 - Third Floor, Research Department
City
Tabriz
Province
East Azarbaijan
Postal code
5138947-977
Phone
+98 41 3335 7311
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
maryam nematzadeh
Position
Masters in Midwifery Counseling Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shariaty St. - Tabriz School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mari.nematzadehbel@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Soheila Bani
Position
Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shariaty St. - Tabriz School of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
banis@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
maryam nematzadeh
Position
Masters in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Shariaty St. - Tabriz School of Nursing and Midwifery
City
tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
mari.nematzadehbel@gmail.com
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