Protocol summary

Study aim
Determining the effect of education based on sexual self-concept model on self-confidence and sexual self-efficacy of postpartum women referred to Alborz University of Medical Sciences
Design
The clinical trial has 120 participants in two groups of control and intervention which are divided into two groups using four random blocks.
Settings and conduct
the researcher will attend to the Eastern Health Centers of Alborz University of Medical Sciences and will provide a list of mothers who gave birth six weeks ago from the sib system. then the researcher will call the participants and will explain the Backgrounds of the research objectives and will obtain oral and written consent from them, sampling will be done from the people who have the conditions to enter the study and in order to observe research ethics, a written consent will be obtained from the spouses. and both groups of participants will answer the questionnaires of demographic characteristics, sexual confidence and sexual self-efficacy at the beginning of the research and then . This process is done in person and online on the WhatsApp social network in six 30-minute training sessions twice a week for a period of one month. These sessions are based on the model of sexual self-concept and the control group is under the routine care. Immediately after completing the training sessions and one month later, the questionnaire of sexual self-confidence and sexual self-efficacy will be completed again by all participants
Participants/Inclusion and exclusion criteria
Entry: Six weeks have passed since the delivery day. Exit: One year has passed since the delivery day.
Intervention groups
The effect of education based on sexual self-concept model on sexual self efficacy and self esteem in the intervention group, the control group is under previous routine care.
Main outcome variables
Impact on sexual self efficacy and sexual self esteem

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220530055025N1
Registration date: 2022-07-05, 1401/04/14
Registration timing: registered_while_recruiting

Last update: 2022-07-05, 1401/04/14
Update count: 0
Registration date
2022-07-05, 1401/04/14
Registrant information
Name
mana mousavi
Name of organization / entity
Alborz university os medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 3697
Email address
manamusavi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-09, 1401/03/19
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
2022-06-09, 1401/03/19
Actual recruitment end date
2022-08-10, 1401/05/19
Trial completion date
2022-08-23, 1401/06/01
Scientific title
The effect of education based on sexual self_concept model on sexual self_esteem and sexual self_efficacy of postpartum women referred to educational and medical centers of alborz university of medical sciences.
Public title
The effect of education based on sexual self_concept model on sexual self_esteem and sexual self_efficacy of postpartum women referred to educational and medical centers of alborz university of medical sciences.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being sexually active Being able to attend in online sessions At least 6 weeks have passed since the mother gave birth
Exclusion criteria:
Having a defect in body or burn Addiction Passing a year after mother's giving birth
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Selected samples will be divided into intervention and control groups using 4 random blocks
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
_

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Alborz university of medical sciences
Street address
Alborz University of Medical Sciences, Administrative Town, North Taleghani Boulevard, Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Approval date
2022-05-08, 1401/02/18
Ethics committee reference number
IR.ABZUMS.REC.1401.027

Health conditions studied

1

Description of health condition studied
Sexual self-esteem and sexual self-efficacy
ICD-10 code
F53
ICD-10 code description
Mental and behavioral disorders associated with the puerperium

Primary outcomes

1

Description
Sexual self esteem
Timepoint
At the beginning of the study (before the start of the intervention), immediately after the intervention and 30 days after the end of the intervention.
Method of measurement
Questionnaire of sexual self esteem based on sexual self concept model

2

Description
Sexual self efficacy
Timepoint
At the beginning of the study (before the start of the intervention), immediately after the intervention and 30 days after the end of the intervention.
Method of measurement
Questionnaire of sexual self efficacy based on sexual self concept model

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 60 women who have passed six weeks after delivery and are referred to Alborz University of Medical Sciences who were randomly selected from 120 sample
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kamali hospital
Full name of responsible person
Mana Mousavi
Street address
Kamali Educational and Medical Center, Kamali street, Shohada square
City
Karaj
Province
Alborz
Postal code
31348 77179
Phone
+98 26 3223 7001
Fax
+98 26 3220 4975
Email
Kamali@abzums.ac.ir
Web page address
https://kamali.abzums.ac.ir/fa-IR/kamali.abzums.ac/9583/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alborz university of medical sciences
Full name of responsible person
Doctor Javad Moazami
Street address
Alborz University of Medical Sciences, Administrative Town, North Taleghani Boulevard, Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Email
info@abzums.ac.ir
Web page address
https://www.abzums.ac.ir/fa-IR/DouranPortal/1/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alborz 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
Alborz university of medical sciences
Full name of responsible person
Doctor Sara Esmaeelzade Saeie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Alborz University of Medical Sciences, Administrative Town, North Taleghani Boulevard, Taleghani Square, Karaj
City
Karaj
Province
Alborz
Postal code
3149779453
Phone
+98 26 3419 7000
Fax
+98 26 3419 7000
Email
esmaelzadeh1360@gmail.com
Web page address
https://www.abzums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alborz university of medical sciences
Full name of responsible person
Mana Mousavi
Position
M.sc student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Unit 2, No. 15, Yas Alley, First Golha St, Ayatollah Kashani St.
City
Tehran
Province
Tehran
Postal code
1471848894
Phone
+98 21 4401 3697
Fax
+98 21 4401 3697
Email
manamusavi@gmail.com
Web page address
https://www.abzums.ac.ir/fa-IR/DouranPortal/1/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C

Person responsible for updating data

Contact
Name of organization / entity
Alborz university of medical sciences
Full name of responsible person
Mana Mousavi
Position
M.sc student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Unit 2, No. 15, Yas Alley, First Golha street, Ayatollah Kashani street.
City
Tehran
Province
Tehran
Postal code
1471848894
Phone
+98 21 4401 3697
Fax
+98 21 4401 3697
Email
manamusavi@gmail.com
Web page address
https://www.abzums.ac.ir/fa-IR/DouranPortal/1/page/%D8%B5%D9%81%D8%AD%D9%87-%D8%A7%D8%B5%D9%84%DB%8C

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participants' answers to the questionnaire on sexual confidence and self-efficacy
When the data will become available and for how long
After September 2022
To whom data/document is available
Research data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
I do not know now
From where data/document is obtainable
for access to my thesis you can find it in university's library
What processes are involved for a request to access data/document
I do not know now
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