The effect of psycho-sexual counseling based on the cognitive-behavioral approach to improving women's genital self-image and reinforcing their reproductive health: a randomized clinical trial study
Determine the effects of psycho-sexual counseling based on the cognitive-behavioral approach to improving women's genital self-image and reinforcing their reproductive health
Design
Two arms parallel-group randomized trial. the sample size determine 54 for each group and a total of 108. In this study, the randomization method will be a randomized block design with a block size of 4.
Settings and conduct
The list of eligible women aged 15-49 years has been prepared by a researcher from Amol health centers and women will be randomly assigned to two test or control groups. The first intervention session will be held at the health care center and the rest of the intervention sessions due to the Corona pandemic will be provided online and offline through Skyroom and WhatsApp software.
Participants/Inclusion and exclusion criteria
Having Iranian nationality
reading and writing literacy
Being married
Sexuality active
not being pregnant
not being Menopause
not being in the first six months after childbirth
Having a mobile phone with an Android system and internet access
Satisfaction and voluntary participation
Healthy women in terms of genital anatomy based on self-report
Absence of major psychiatric disorders based on self-report (such as depression, anxiety, obsession)
No history of genital surgeries such as hysterectomy, oophorectomy
No cancer in the genital area (like vagina cancer, cervix cancer)
Intervention groups
The intervention group will spend 8 weeks, one session per week and each session for 90 minutes in the Skyroom space, and will receive the content of the intervention provided by the researcher.The provided content will also be placed in the WhatsApp group space. Standard questionnaires will be completed before, immediately, and 2 months after the intervention in the control group
Main outcome variables
Promoting women's genital image and their reproductive health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220302054166N1
Registration date:2022-05-11, 1401/02/21
Registration timing:prospective
Last update:2022-05-11, 1401/02/21
Update count:0
Registration date
2022-05-11, 1401/02/21
Registrant information
Name
Mina Malary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
malary@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-28, 1401/03/07
Expected recruitment end date
2022-06-28, 1401/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psycho-sexual counseling based on the cognitive-behavioral approach to improving women's genital self-image and reinforcing their reproductive health: a randomized clinical trial study
Public title
The effect of psycho-sexual counseling based on the cognitive-behavioral approach to improving women's genital self-image and reinforcing their reproductive health
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having Iranian nationality
reading and writing literacy
Being married
Sexuality active
not being pregnant
not being Menopause
not being in the first six months after childbirth
Having a mobile phone with Android system and internet access
Satisfaction and voluntary participation
Healthy women in terms of genital anatomy based on self-report
Absence of major psychiatric disorders based on self-report (such as depression, anxiety, obsession)
No history of genital surgeries such as hysterectomy, oophorectomy
No cancer in the genital area (like vagina cancer, cervix cancer)
Exclusion criteria:
Unwillingness of the women to continue participating in the study
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization method will be a randomized block design with a block size of 4. The block randomization method is designed to randomize participants into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time. in this clinical trial with control and treatment groups, a randomized block procedure would be as follows: (1) block size of 4 will be chosen, (2) possible balanced combinations with 2 T (intervention) and 2 C (control) subjects will be calculated as 6 (CCTT, CTCT, CTTC, TCCT, TCTC, TTCC) and (3) blocks will be randomly chosen to determine the assignment of all participants.
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
Ethics committee of Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Square, Shahroud, Iran
City
Shahroud
Province
Semnan
Postal code
3614773955
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.SHMU.REC.1398.127
Health conditions studied
1
Description of health condition studied
genital self-image in women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
genital self-image
Timepoint
Before the intervention, immediately and 2 months after the intervention
Method of measurement
d Female Genital Self-Image Scale(FGSIS)
Secondary outcomes
1
Description
Reproductive health (Intention of Reproductive Health Promoting Behaviors and sexual health (such as sexual function, sexual distress, sexual self-esteem, and sexual satisfaction)
Timepoint
Before the intervention, immediately and 2 months after the intervention
Method of measurement
The intention of Reproductive Health Promoting Behaviors, (Female Sexual Distress Scale-Revised(FSDS-R)), (Female Sexual dysfunction index(FSFI-6)), Sexual self-esteem, sexual satisfaction
Intervention groups
1
Description
The intervention group will spend 8 weeks, one session per week (8 sessions in total) and each session for 90 minutes in the Skyroom space, the link of which has been sent to them via WhatsApp, and will receive the content of the intervention provided by the researcher. On the other hand, the content provided will be placed in the WhatsApp group space so that participants can refer to it again and use it if they wish. In addition, if you have any questions, mention them in the group so that the researcher can review and answer them.
Category
N/A
2
Description
Control group: The control group will receive the mobile application but they did not access the intervention content until the end of the research. Then, based on the ethics of the research and their willingness can use the content of Intervention. Standard questionnaires will be completed before, immediately after 6 sessions of intervention, and 2 months after the intervention in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Amol healthcare centers,Mazandaran province
Full name of responsible person
Mina Malary
Street address
Talib Amoli Street
City
Amol
Province
Mazandaran
Postal code
4615746173
Phone
+98 11 4425 3237
Email
Minamalary@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hassan Emamian
Street address
Shahroud University of Medical Sciences and Health Services, Hafte Tir Sq. Shahroud, Iran.
City
Shahroud
Province
Semnan
Postal code
36147-73947
Phone
+98 23 3239 4499
Email
pishgiri@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Farjamfar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
7tir street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
viraa.academy@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Maryam Farjamfar
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
7tir street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
+98 23 3239 5054
Email
viraa.academy@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mina Malary
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
7tir street
City
Shahroud
Province
Semnan
Postal code
3614773947
Phone
009832935054
Email
Minamalary@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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