Investigating the effect of intervention with psychosexual approach on sexual self-care of young girls
Design
Two-arm parallel-group randomized trial. The sample size was determined 60 for each group and a total of 120. In this study, the randomization method will be a randomized block design with a block of size 4.
Settings and conduct
The place of study is Tehran University of Medical Sciences. The study population is the first-year unmarried female students of Tehran University of Medical Sciences. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being female; Being single; Freshman in medical science
Exclusion criterion: Participation in another clinical trial
Intervention groups
The intervention group will have access to the intervention content weekly for 4 weeks. The control group will receive content unrelated to the research and will not have access to the content of the self-care promotion intervention until the end of the research.
Main outcome variables
Sexual self-care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160808029255N14
Registration date:2023-10-29, 1402/08/07
Registration timing:prospective
Last update:2023-10-29, 1402/08/07
Update count:0
Registration date
2023-10-29, 1402/08/07
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
2024-01-21, 1402/11/01
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intervention with psychosexual approach on sexual self-care of unmarried young girls
Public title
The effect of psychosexual intervention on girls' sexual self-care
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being female
Being single
Freshman in medical science
Exclusion criteria:
Participation in other clinical trials
Age
From 18 years old to 29 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by block method and using the randomization table made with Random Allocation Software with blocks of four and individual randomization units. In order to hide the random allocation from the researcher, envelopes are prepared as many as the sample size, and each of the random sequences created is recorded on paper and placed inside the envelope, and finally, the lids of the envelopes are glued. At the time of registration of people, based on the order of samples, one of the envelopes will be opened and the assigned group of that sample will be determined.
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
Faculty of Nursing and Midwifery, East Nosrat Ave., Towhid Sq. Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-09-03, 1402/06/12
Ethics committee reference number
IR.TUMS.FNM.REC.1402.122
Health conditions studied
1
Description of health condition studied
Sexual self-care
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual self-care
Timepoint
Before the intervention, immediately after the intervention and 3 months after the intervention
Method of measurement
Sexual self-care questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will have access to the intervention content online and offline weekly for 4 weeks (8 sessions). The content of the intervention includes training in the dimensions of sexual and gender identity of girls and boys, sexual and reproductive rights, meeting sexual needs, marriage, sexually transmitted infections, unwanted pregnancy, unsafe abortion, and life skills. During the intervention period, the researcher will answer questions related to the intervention in a WhatsApp support group to follow up and prevent people from dropping out. The standard questionnaires will be completed again before and after the end of the intervention, as well as 3 months after the end of the intervention.
Category
N/A
2
Description
Control group: The control group will receive content unrelated to the research and will not have access to the content of the intervention promoting self-care until the end of the research, but after that, to comply with the principles of research ethics, they can use the content of the intervention if needed and desired. The standard questionnaires will be completed again before and after the completion of 8 intervention sessions, as well as 3 months after the completion of the intervention in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences
Full name of responsible person
Raziyeh Masoumi
Street address
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.Akbar Fotouhi
Street address
Qods street; Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
afotouhi@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
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.masoomie@gmail.com
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
Reproductive Health
Street address
Faculty of Nursing and Midwifery, 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
Reproductive Health
Street address
Faculty of Nursing and Midwifery, 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
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
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
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 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
Sending a request by email attendance to the office of corresponding project presentation the reasons for the similarity of two projects studying the proposal by corresponding of project final decision making with corresponding author access of data in the office of the corresponding author