The effect of Remote Group intervention on sexual health literacy, sexual function, sexual self-efficacy and quality of sexual life of women in reproductive age:A randomized clinical trial study
The effect of Remote Group intervention on sexual health literacy, sexual function, sexual self-efficacy and quality of sexual life of women in reproductive age:A randomized clinical trial study
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
Women of reproductive age from health centers in Amol city will be selected randomized in intervention and control groups and The content of the intervention will be taught offline mode by using WhatsApp.
Participants/Inclusion and exclusion criteria
1-Iranian originality,2- reading and writing literacy,3- marriage , 4-Not having physical or mental diseases affecting sexual health of the woman or her husband, 5-Not having critical marital conflicts or not being on the verge of divorce 6-Not previous participation in Sex education classes 7-Willingness to attend all meetings 8-to cross At least one year of living together9- Not infection to Known sexual dysfunction like Vaginismus 10- not being pregnant and Menopause 11- Do not consume of Cigarettes, Alcohol and no addiction in woman or her husband12-Do not take any Psychotropic or psychoactive drug or Drugs affecting the sexual response cycle during intervention by woman or her husband 13- Having a mobile phone with Android system 14-Access to internet
Intervention groups
The intervention group, will have access to the Content of the intervention as offline mode for 8 weeks, and during this time, in online and offline peer's Whatsapp group, the content of the intervention will be analyzed Weekly by researcher for further training and the asked question in the groupfor further training .
Main outcome variables
sexual health literacy; Qualiry of sexual life; sexual self efficacy; sexual function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N10
Registration date:2021-01-10, 1399/10/21
Registration timing:prospective
Last update:2021-01-10, 1399/10/21
Update count:0
Registration date
2021-01-10, 1399/10/21
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
2021-01-20, 1399/11/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Remote Group intervention on sexual health literacy, sexual function, sexual self-efficacy and quality of sexual life of women in reproductive age:A randomized clinical trial study
Public title
The effect of Remote Group intervention on sexual health literacy, sexual function, sexual self-efficacy and quality of sexual life of women in reproductive age
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian originality
reading and writing literacy
marriage
Not having physical or mental diseases affecting sexual health of the woman or her husband
Not having critical marital conflicts or not being on the verge of divorce
Not previous participation in Sex education classes
Willingness to attend all meetings
At least one year of living together
Not infection to Known sexual dysfunction like Vaginismus
not being pregnant and Menopause
Do not consume of Cigarettes, Alcohol and no addiction in woman or her husband
Do not take any Psychotropic or psychoactive drug or Drugs affecting the sexual response cycle during intervention by woman or her husbandHaving
having a mobile phone with Android system
Access to internet
Exclusion criteria:
exclution criteria: Unwillingness of the women to continue participating in the study
Age
From 25 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Street address
East Nosrath., Towhid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-07-08, 1398/04/17
Ethics committee reference number
IR.TUMS.FNM.REC.1398.077
Health conditions studied
1
Description of health condition studied
sexual health literacy
ICD-10 code
ICD-10 code description
2
Description of health condition studied
sexual function
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Quality of sexual life
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Sexual self-efficacy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sexual health literacy
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Iranian Adult Sexual Health Literacy Standard Questionnaire
2
Description
sexual function
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
The standardized Persian version of the six-item women's sexual function index
3
Description
Quality of sexual life
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Standardized questionnaire Quality of sexual life for Iranian women
4
Description
sexual self-efficacy
Timepoint
Before the intervention, immediately and one month after the intervention
Method of measurement
Standardized questionnaire of sexual self-efficacy for Iranian women
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group, will have access to the Content of the intervention as offline mode weekly for 8 weeks, and during this time, in online and offline peer's Whatsapp group, the content of the intervention will be analyzed Weekly by researcher for further training and the asked questions of individuals will be solved in the group .Standard questionnaires will be complete before and immediately after 8 sessions of intervention and also one month after the intervention.
Category
N/A
2
Description
Control group: The control group will receive information about Covid-19 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 complete before and immediately after 8 sessions of intervention and also to one month after the intervention in control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Amol city
Full name of responsible person
Raziyeh Maasoumi
Street address
East Nosrath., Towhid Sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
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.Mohammad Ali Sahraian
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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Reproductive Health
Street address
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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Reproductive Health
Street address
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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sexology, Reproductive Health
Street address
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 publications of findings
To whom data/document is available
Data of this research would be available for academic researchers
Under which criteria data/document could be used
Data of this study would be available for same research
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