Protocol summary

Study aim
Investigating the Effectiveness of Sexual Interventions on Sexual Awareness, Sexual Depression, and High-Risk Behaviors of Abused Women
Design
A clinical trial was conducted with a control group and parallel groups, non-blinded, randomized, involving 100 patients. The randomization was performed using the rand function in Excel software.
Settings and conduct
The research population includes women who have visited clinics in Tehran. The sampling method used is convenience sampling, with a sample size of 100 individuals. The study follows a quasi-experimental design with an approach involving an experimental group and a control group. The research data will be analyzed using the statistical software SPSS, and inferential statistics along with multiple analyses of covariance (ANCOVA) will be employed.
Participants/Inclusion and exclusion criteria
Inclusion criteria : abused woman ,minimum literacy, Having a sexual partner Exclusion criteria : Observing symptoms of psychiatric disorders ; addiction
Intervention groups
The effectiveness of sexual intervention on sexual awareness, sexual depression, and risky sexual behaviors is being investigated in the intervention group consisting of single mothers. This intervention is carried out on them in 6 sessions, each lasting 1.5 hours.
Main outcome variables
Sexual awareness Sexual depression High risk behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230613058472N1
Registration date: 2023-11-27, 1402/09/06
Registration timing: retrospective

Last update: 2023-11-27, 1402/09/06
Update count: 0
Registration date
2023-11-27, 1402/09/06
Registrant information
Name
Romina Mostafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 454 0407
Email address
rominamostafaeii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-02, 1402/01/13
Expected recruitment end date
2023-08-22, 1402/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of sexual health intervention on sexual awareness, sexual depression and high-risk behaviors of abused women in Tehran
Public title
Effectiveness of sexual education in promoting sexual health and sexual awareness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Abused women Having literacy skills ( reading and writing ) Age 18 up to and 45 years old Informed consent of the individual Having a sexual partner
Exclusion criteria:
Observing psychotic symptoms despite the presence of other severe psychiatric disorders based on a psychiatric interview according to the DSM Addition issues
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Clinical trial with a control group, parallel groups, non-blinded, simple individual randomization, unstratified and unmasked was conducted on 100 patients. Randomization was performed using the rand function in Excel and R software. The intervention was conducted in six sessions for the first group, while the control group was placed on a waiting list for treatment and education after the study. The sample size of the study is 100 individuals, and random assignment of individuals to the two groups was done using Excel and R software version 4.0.3. Using the code [c(“a”, “b”), 100, replace = TRUE, prob = c(.5, .5)], the output generated random assignments such as “a”, “a”, “b”, “a”, etc. The first person was assigned to group “a”, the second person to group “b”, the third person to group “a”, and the fourth person to group “a”. This process was repeated until all 100 individuals were randomly assigned to the two groups of 50 individuals each.
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
No 13, 31 Sharghi Ave, Saadat abad Blv
City
Tehran
Province
Tehran
Postal code
1998815958
Approval date
2023-05-23, 1402/03/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.033

Health conditions studied

1

Description of health condition studied
Sexual dysfunction
ICD-10 code
F52
ICD-10 code description
Sexual dysfunction not due to a substance or known physiological condition

2

Description of health condition studied
The outcome of reducing risky sexual behaviors involves a decrease in the risk of sexually transmitted infections and negative consequences associated with such behaviors, such as unintended pregnancies. It also entails an increase in sexual safety awareness and knowledge about protective measures. Reducing risky sexual behaviors implies making smarter and more responsible choices in sexual relationships, utilizing contraception methods, and being aware of the risks associated with inappropriate sexual behaviors.Increasing sexual awareness can also have positive effects on sexual relationships and sexual satisfaction
ICD-10 code
Z72.5
ICD-10 code description
High risk sexual behavior

3

Description of health condition studied
The consequences of increasing sexual awareness are multifaceted and can have positive impacts on individuals and their sexual experiences. Here are some potential outcomes of increasing sexual awareness:1. Improved Sexual Satisfaction: By enhancing their understanding of their own bodies, desires, and preferences, individuals can experience increased sexual satisfaction. They become more aware of what brings them pleasure and are better able to communicate their needs to their partners.2. Enhanced Communication and Intimacy: Sexual awareness promotes open and effective communication about sexual desires, boundaries, and consent. This improved communication fosters a deeper sense of intimacy and trust in sexual relationships.3. Increased Sexual Health: Sexual awareness involves knowledge about safe sex practices, contraception methods, and sexually transmitted infections (STIs). With increased awareness, individuals are more likely to engage in responsible sexual behavior, reducing the risk of STIs and unplanned pregnancies.4. Empowerment and Confidence: Understanding and accepting one's own sexuality can boost self-esteem and confidence. Increased sexual awareness allows individuals to embrace their desires without shame or guilt, leading to a healthier and more positive sexual self-image.5. Cultivation of Healthy Relationships: Sexual awareness encourages individuals to seek out and maintain healthy, consensual relationships. They become more attuned to their own needs and are better equipped to create mutually satisfying sexual experiences within a relationship.6. Prevention of Sexual Coercion and Abuse: With increased sexual awareness, individuals are more likely to recognize and resist situations involving sexual coercion or abuse. They become aware of their rights, boundaries, and the importance of enthusiastic consent.Overall, increasing sexual awareness can contribute to a more fulfilling and empowered sexual life, fostering healthier relationships and promoting personal well-being.
ICD-10 code
Z70.1
ICD-10 code description
Counseling related to patient's sexual behavior and orientation

Primary outcomes

1

Description
Sexual depression
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Snell Sexual Problems Scale

2

Description
Risky sexual behaviorspractices.
Timepoint
Before the intervention and one week after the intervention
Method of measurement
High risk behaviors Scale

3

Description
Sexual awareness
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Snell sexual Problems Scale

Secondary outcomes

1

Description
Sexual and emotional relationships
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

2

Description
Prevention of sexually transmitted diseases
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

3

Description
Change in negative and discriminatory attitudes
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

4

Description
Reduction of sexual anxiety and concerns
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

5

Description
Increasing sexual respect
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

6

Description
Sexual mental engagement
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

7

Description
Internal sexual control
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

8

Description
Sexual motivation
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

9

Description
Sexual supervision
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

10

Description
Fear of sexual intercourse
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Sexual Problems Scale

Intervention groups

1

Description
Intervention Group: Six sessions of sexual education and intervention based on a prepared educational package aimed at increasing sexual awareness and health, reducing risky behaviors, and addressing sexual depression. Each session lasts one and a half hours, with one day in between sessions.Session 1: Sexual Awareness- Individual aspects of sexual life and sexual health education- Sexual hygiene education- Sexual health during different stages of life (adolescence, menstruation, menopause)- Genital system: male and female reproductive organs, breastsSession 2: Sexual Behavior- Understanding sexual behavior and relationships- Stages of sexual relationships- Sexual response cycle- Types of sexual relationships (oral sex, anal sex, intercourse)- Sexuality in specific life periods- Sexual misconduct- Misconceptions about sexual relationships- Comparison of sex and pornographySessions 3 and 4: Sexual Diseases and Disorders- Prevention, diagnosis, and treatment of sexually transmitted diseases- Sexual disorders and deviations- Risk factors for sexual disorders- Common sexual disorders- Paraphilic disorders- Sexual depression- Risk factors for sexual diseases- Sexually transmitted diseases (STDs)- Sexual treatments and interventionsSession 5: Pregnancy, Birth Control, and Abortion- Important aspects of pregnancy- Birth control methods and prevention of pregnancy- Methods of abortionNote: The provided translation is an approximation of the original text, and some terms may vary depending on context.
Category
Treatment - Other

2

Description
Control Group: The control group is placed in the waiting list and will participate in psychotherapy sessions after the research is completed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mehramana specialized psychology clinic
Full name of responsible person
Romina Mostafaei
Street address
No1, Parkway Ave
City
Tehran
Province
Tehran
Postal code
198815958
Phone
+98 21 2266 5350
Email
rominamostafaeii@ahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Romina Mostafaeii
Street address
No1,Parkway Blvd
City
Tehran
Province
Tehran
Postal code
1998815958
Phone
+98 21 2266 5350
Email
rominamostafaeii@yahoo.com
Web page address
http://www.mehrclinicmana.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Science
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
Mehremana clinic
Full name of responsible person
Romina Mostafaei
Position
Psychologist
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No13, 31 Sharghi Ave , Saadat Abad Blv
City
Tehran
Province
Tehran
Postal code
1998815958
Phone
+98 21 2266 5350
Email
rominamostafaeii@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mehremana clinic
Full name of responsible person
Romina Mostafaei
Position
Psychologist
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No13, 31 Sharghi Ave , Saadat Abad Blv
City
Tehran
Province
Tehran
Postal code
1998815958
Phone
009822665350
Email
rominamostafaeii@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Mehremana clinic
Full name of responsible person
Romina Mostafaei
Position
Psychologist
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No13,31Sharghi Ave , Saadat Abad Blvd
City
Tehran
Province
Tehran
Postal code
1998815958
Phone
009822665350
Email
rominamostafaeii@yahoo.com

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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The entire research process includes sampling, intervention, pre-test and post-test, data collection, statistical analysis and conclusions.
When the data will become available and for how long
One year after the research
To whom data/document is available
Researchers and specialists in the field of mental health and treatment staff
Under which criteria data/document could be used
Having a history related to psychology, psychiatry and social sciences
From where data/document is obtainable
rominamostafaei@yahoo.com
What processes are involved for a request to access data/document
After sending the request, the researcher will check it and answer it
Comments
Loading...