Determining the effect of virtual education to promote of sexual function, genital self – image and sexual distress in women with Rokitansky syndrome
Design
This research is a randomized clinical trial with two groups; intervention and control. Sampling will be conducted by block design (with block size of 4) random allocation.
Settings and conduct
The research environment is pelvic floor clinic of Emem khomeini hospital.
Participants/Inclusion and exclusion criteria
- Inclusion criteria:Being Iranian/ Married and Monogamy/ Being in Reproductive age (15-49 years)/ Having media literacy/ Having a mobile phone with Android system/ Access to internet/ Check of medical documentation, including ultrasound or MRI or laparoscopic reports of the diagnosis of Rokitansky syndrome by the researcher/ Spending at least 6 months of vaginoplasty (surgically or non- surgically method)/ Having vaginal intercourse. exclusive criteria:Having the therapeutic course of ovule reservation, including puncture of ovarian and pick up ovum/ Having chronic diseases affecting on sexual function/ Using of drugs that affected on sexual function/ Having educational background related with this study.
Intervention groups
The intervention group, after installing the mobile app, will have access to the content as offline mode for 2 months, and during this 2 months, in online peer's telegram group, the content of the app will be analyzed by researcher for further training and the sexual problems of individuals will be solved in the group or, In case of reluctance, in private chat will be done.The control group will not receive any intervention until the end of the research. Then, based on the ethics of the research and their willingness can use the content of app.
Main outcome variables
Sexual function, Genital self - image, Sexual distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N7
Registration date:2019-07-31, 1398/05/09
Registration timing:prospective
Last update:2019-07-31, 1398/05/09
Update count:0
Registration date
2019-07-31, 1398/05/09
Registrant information
Name
Raziyeh Maasoumi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4214
Email address
r_masoumi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual education to promote of sexual function, genital self – image and sexual distress in women with Rokitansky syndrome
Public title
The effect of virtual education to promote of sexual function, genital self – image and sexual distress in women with Rokitansky syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Married and Monogamy
Being in Reproductive age (15-49 years)
Having media literacy
Having a mobile phone with Android system
Access to internet
Check of medical documentation, including ultrasound or MRI or laparoscopic reports of the diagnosis of Rokitansky syndrome by the researcher
Spending at least 6 months of vaginoplasty (surgically or non- surgically method)
Having vaginal intercourse
Exclusion criteria:
Having the therapeutic course of ovule reservation, Including puncture of ovarian and pick up ovum
Having chronic diseases that affected on sexual function
Using of drugs that affected on sexual function
Having educational background related with this study
Unwillingness to continue cooperation
Lack of comprehensive and regular study of the content of the mobile app
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:
38
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization method will be randomized block design with 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) a block size of 4 will be chosen, (2) possible balanced combinations with 2 A (intervention) and 2 B (control) subjects will be calculated as 6 (BBAA, BABA, BAAB, ABBA, ABAB, AABB) 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 Tehran University of Medical Sciences, school of Nursing and Midwifery & Rehabil
Street address
Faculty of Nursing and Midwifery, South Nosrat Ave., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.TUMS.FNM.REC.1398.067
Health conditions studied
1
Description of health condition studied
Sexual function
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Genital self - image
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Sexual distress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual function
Timepoint
Before the intervention, immediately and 4 weeks after the intervention
Method of measurement
Female Sexual Function Index questionnaire
2
Description
Genital self - image
Timepoint
Before the intervention, immediately and 4 weeks after the intervention
Method of measurement
Female Genital Self-Image Scale questionnaire
3
Description
Sexual distress
Timepoint
Before the intervention, immediately and 4 weeks after the intervention
Method of measurement
Female Sexual Distress Scale __ Revised questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group, after installing the mobile app, will have access to the content as offline mode for 2 months, and during this 2 months, in online peer's telegram group, the content of the app will be analyzed by researcher for further training and the sexual problems of individuals will be solved in the group or, In case of reluctance, in private chat will be done.
Category
N/A
2
Description
Control group: The control group will not receive any intervention until the end of the research. Then, based on the ethics of the research and their willingness can use the content of app.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Raziyeh Masoumi
Street address
Tehran, Keshavarz Blvd.
City
TEHRAN
Province
Tehran
Postal code
1419733171
Phone
+98 21 6119 0000
Email
r_masoumi@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraian, the Vice Chancellor of Research at Tehran University of Medicine Sciences
Street address
Keshavarz Blv., Qods St.,
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.,
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Maasoumi
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Sexual and Reproductive Health
Street address
Faculty of Nursing and Midwifery, East Nosrath., Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data of the study would be available after unrecognizable process of participants.
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
Research results would be available for academic researchers
Under which criteria data/document could be used
Research results would be available for same researches
From where data/document is obtainable
Dr. Raziyeh Maasoumi email: r_masoumi@sina.tums.ac.ir
What processes are involved for a request to access data/document
Sending a request by email attendance to the office of corresponding of project presentation the reasons for similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in office of corresponding author