Determine the effects of psychosexual education on help-seeking of young adult women for sexual concerns
Design
Two arms parallel-group randomized trial. the sample size determine 70 for each group and a total of 140.
In this study, the randomization method will be randomized block design with a block size of 4.
Settings and conduct
Women between 18-40 years old that registered for premarital classes in the only health center for premarital classes in Rasht city will be selected randomized in intervention and control groups and the content of the intervention will be taught using a mobile application
Participants/Inclusion and exclusion criteria
Reading and writing literacy
Urbanization
Marriage
No pregnancy history
Sexuality active
At least one year of living together
Not being pregnant and menopause
Having a mobile phone with an Android system
Access to Internet
Intervention groups
The intervention group will have access to the content of the intervention as a mobile application weekly for 6 weeks, and during this time, in peer's WhatsApp group, the content of the intervention will be analyzed Weekly by the researcher for further training and the asked questions of individuals will be solved in the group. We will ask them to share content with their husband standard questionnaires will be completed before and immediately after intervention and 2 months after the intervention.
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.
Main outcome variables
Help-seeking, help-seeking intention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N12
Registration date:2021-12-23, 1400/10/02
Registration timing:prospective
Last update:2021-12-23, 1400/10/02
Update count:0
Registration date
2021-12-23, 1400/10/02
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
2022-01-05, 1400/10/15
Expected recruitment end date
2022-02-04, 1400/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of the psycho-sexual intervention on help-seeking in coping with sexual concerns of young women, a randomized controlled trial
Public title
The effects of the psycho-sexual intervention on help-seeking in coping with sexual concerns of young women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Reading and writing literacy
Urbanization
Marriage
No pregnancy history
Sexuality active
At least one year of living together
Not being pregnant and menopause
Having a mobile phone with Android system
Internet access
Exclusion criteria:
Unwillingness of the women to continue participating in the study
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the randomization method will be 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 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 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
2019-11-12, 1398/08/21
Ethics committee reference number
IR.SHMU.REC.1398.097
Health conditions studied
1
Description of health condition studied
Help-seeking
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Help-seeking intention
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Openness to help-seeking
ICD-10 code
ICD-10 code description
4
Description of health condition studied
Self-stigma
ICD-10 code
ICD-10 code description
5
Description of health condition studied
Sexual assertiveness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Help-seeking
Timepoint
Before the intervention, immediately and 2 months after the intervention
Method of measurement
Actual help-seeking questionnaire
2
Description
Help-seeking intention
Timepoint
Before the intervention, immediately and 2 months after the intervention
Method of measurement
General help-seeking questionnaire
3
Description
Openness to help-seeking
Timepoint
Before the intervention, immediately and 2 months after the intervention
Method of measurement
Modified version of attitudes toward professional help-seeking scale
4
Description
Self-stigma
Timepoint
Before the intervention, immediately and 2 months after the intervention
Method of measurement
Self-stigma questionnaire
5
Description
Sexual assertiveness
Timepoint
Before the intervention, immediately and 2 months after the intervention
Method of measurement
Hulbert sexual assertiveness questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will have access to the content of the intervention as a mobile application weekly for 6 weeks, and during this time, in peer's WhatsApp group, the content of the intervention will be analyzed weekly by the researcher for further training and the asked questions of individuals will be solved in the group. We will ask them to share content with their husband standard questionnaires will be completed before and immediately after intervention and 2 months after the intervention.
Category
N/A
2
Description
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
Rasht referral health center for premarital education
Full name of responsible person
Shadi Sabetghadam
Street address
Health Center No. 8 - Daneshjoo Park.
City
Rasht
Province
Tehran
Postal code
4157648449
Phone
+98 13 3355 0990
Email
shadisabetghadam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
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 5054
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
30
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 Nosrat, Towhid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4214
Email
r_masoumi@sina.tums.ac.ir
Web page address
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 Nosrat, 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 Nosrat, 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 the unrecognizable process of participants.
When the data will become available and for how long
Six 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 the 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
Initial correspondence by email, on-site visit, and presentation of a proposal similar to the present study, provide sufficient evidence for the similarity of its research to the present study, study proposal by the present investigator, decision making and announcement of the result by the investigator to the researcher for access to data Providing the data file for use locally