Reproductive HealthNCT05864430
Effıcıency of Sexual and Reproductıve Health Educatıon
A study testing Face-to-face Training Group, DataMatrix supported Face-to-face training group and Online training group in people with Reproductive Health and Sexual Health, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The youth period is a period when information and education are important. Reproductive and sexual health problems have an important place in aging health problems in youth (Gölbaşlı 2003). All over the world, STIs are most common in the 20-24 age group, followed by the 15-19 and 25-29 age groups. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health, Sexual Health
- What is being tested?
- Face-to-face Training Group, DataMatrix supported Face-to-face training group and Online training group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the research,
- Have not taken Sexual Health, Infectious Diseases course before
- Students without communication barriers will be included.
Who cannot join
- Incorrect or incomplete form filling
- The participant's wish to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluatıon of The Effıcıency of Sexual and Reproductıve Health Educatıon
The youth period is a period when information and education are important. Reproductive and sexual health problems have an important place in aging health problems in youth (Gölbaşlı 2003). All over the world, STIs are most common in the 20-24 age group, followed by the 15-19 and 25-29 age groups. STIs are the most common disease in many countries, especially among young people between the ages of 15-29 (Topbaş et al. 2003). STIs, which are one of the factors that negatively affect public health; are infections transmitted from person to person through sexual contact. According to WHO estimates, approximately 350 million people suffer from curable STIs each year, and the incidence and prevalence of STIs among young people in developed and developing countries are increasing.
Although young adults are generally at risk, STIs are most common in people aged 15-49. They have a very important place in terms of human health because they are frequently seen, difficult to diagnose, and cause serious complications when not treated. Incomplete and incorrect information among people who start sexual intercourse at an early age causes difficulties in the prevention of these diseases (Özalp et al. 2012).
Read more
Having sexual intercourse at an early age, being polygamous, having special sexual preferences, being with or having sex with those who have paid for sexual intercourse, and not using condoms are among the risk factors for STIs (Siyez 2009).
We can say that the age period in which STIs are common is parallel to sexual activity. In addition to various socio-demographic factors, it is likely that the most provoking issue in this period is the lack of knowledge of young people (Karaköse and Aydın 2011).
In the STD guide published by the CDC, it is recommended to evaluate the people who constitute the risk group in the prevention of these diseases and to provide education and counseling (CDC, 2020). In this context, training to increase the level of knowledge and awareness of young people, who are one of the high-risk groups in society in terms of STD, is important in terms of reducing risky sexual behaviors, early diagnosis, and treatment.
Based on all these reasons; It is aimed to evaluate the effectiveness of sexual and reproductive health education given to university students.
Read the detailed description
During the International Conference on Population and Development held in Cairo in 1994, SRH was covered extensively for the first time and the scope of reproductive and sexual health was expanded (ICPD, 1994). If the concepts that make up the SRH of adolescents and young people are examined, the term sexual health is used to describe the absence of disease and disability related to sexuality and the sense of sexual well-being. It has been defined as a positive combination of the physical, emotional, intellectual, and social aspects of sexuality. Sexuality influences thoughts, feelings, interactions, and actions between individuals, motivating people to find love, contact, warmth, and intimacy. Sexuality can be expressed in many different ways and it has been determined that it is closely linked to the environment in which people live.
Reproductive health is defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity in all matters related to the reproductive system, its functions and processes. Reproductive health therefore means that people can live a satisfying and safe sex life and have the freedom to decide when and how often to use their reproductive capacity. Men and women have the right to have access to safe, effective, affordable and acceptable methods of family planning, the right to be informed, and the right to access health services that will ensure a safe pregnancy and delivery, and the chance to have a healthy baby.
The scope of reproductive health includes methods, techniques and services that contribute to reproductive health and welfare by providing reproductive health care, preventing and solving reproductive health problems. The aim of reproductive health includes not only reproductive and STI-related counseling and care, but also sexual health, which is to improve life and personal relationships (WHO, 2006).Adolescents and young people, like all individuals, have the right to make decisions concerning their own bodies and to access services that support this right. Ensuring sexual and reproductive health for all depends on the realization of sexual and reproductive rights based on human rights (Engel et al., 2019).
Based on all these reasons; In this study, it is aimed to evaluate the effectiveness of sexual and reproductive health education given to university students.
- Conditions
- Reproductive Health, Sexual Health
- Being tested
- Face-to-face Training Group, DataMatrix supported Face-to-face training group, Online training group
- Keywords
- Sexual Health,, Reproductive Health, Online, DataMatrix, Face-to-face training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face Training GroupOther
The training will take approximately 3 hours. The training will be done interactively, allowing students to talk to each other and ask questions, and will end with 10 minutes of time for students' questions.
DataMatrix supported Face-to-face training groupOther
Students will follow the lesson with the QR code given simultaneously with the training given during the education process. The training will be held in such a way that the students will be given the opportunity to ask questions and will end with 10 minutes of time to be given to the questions of the students.
Online training groupOther
The training will take approximately 3 hours. The training will be done interactively, allowing students to talk to each other and ask questions, and will end with 10 minutes of time for students' questions.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face Training Group | Experimental | Students in this group will be given face-to-face training on SRH by the principal researcher accompanied by PowerPoint. Receives: Other: Face-to-face Training Group |
| DataMatrix supported Face-to-face training group | Experimental | Before starting the training, a QR code including PowerPoint on SRH will be given to the students in the group that receives training with QR code support (on the first slide). Students will be directed to the URL automatically determined by the researcher by scanning the QR code with the camera of their smartphones. Students will follow the lesson with the QR code given simultaneously with the training given during the education process. Receives: Other: DataMatrix supported Face-to-face training group |
| Online training group | Experimental | The students in the online training group will be given training on SRH/RES on an online platform accompanied by PowerPoint by the principal researcher. Receives: Other: Online training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Identification Form Diagnostic Form
The participant identification form, which includes the introductory characteristics of the students, was prepared by the researchers in line with the literature (Altay et al., 2020; Vongxay et al., 2019). The form includes students' socio-demographic characteristics, their status of obtaining information about SRH and sources of information, their experiences with SRH and their thoughts on sexual intercourse. The form consists of 28 questions in total.
Measured: 5 Months
Secondary outcomes (1)
Sexual Health Knowledge Test
It was developed by Petili and Gölbaşı in 2017, and its validity-reliability has been made. The test consists of 40 multiple-choice questions and includes 12 sub-dimensions.
Measured: 5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start15 May 2022
- Primary completion30 Sep 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive HealthStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurdan Demirci, Marmara University
- Investigators
- Tuğba Öz, Principal investigator, ev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864430
- Sponsor's protocol ID
- MarmaraU-OZ-2023-sexual
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluatıon of The Effıcıency of Sexual and Reproductıve Health Educatıon
- ClinicalTrials.gov ID
- NCT05864430
- Acronym / sponsor ID
- MarmaraU-OZ-2023-sexual
- Conditions
- Reproductive Health, Sexual Health
- Keywords
- Sexual Health,, Reproductive Health, Online, DataMatrix, Face-to-face training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The youth period is a period when information and education are important. Reproductive and sexual health problems have an important place in aging health problems in youth (Gölbaşlı 2003). All over the world, STIs are most common in the 20-24 age group, followed by the 15-19 and 25-29 age groups. STIs are the most common disease in many countries, especially among young people between the ages of 15-29 (Topbaş et al. 2003). STIs, which are one of the factors that negatively affect public health; are infections transmitted from person to person through sexual contact. According to WHO estimates, approximately 350 million people suffer from curable STIs each year, and the incidence and prevalence of STIs among young people in developed and developing countries are increasing.
Although young adults are generally at risk, STIs are most common in people aged 15-49. They have a very important place in terms of human health because they are frequently seen, difficult to diagnose, and cause serious complications when not treated. Incomplete and incorrect information among people who start sexual intercourse at an early age causes difficulties in the prevention of these diseases (Özalp et al. 2012).
Having sexual intercourse at an early age, being polygamous, having special sexual preferences, being with or having sex with those who have paid for sexual intercourse, and not using condoms are among the risk factors for STIs (Siyez 2009).
We can say that the age period in which STIs are common is parallel to sexual activity. In addition to various socio-demographic factors, it is likely that the most provoking issue in this period is the lack of knowledge of young people (Karaköse and Aydın 2011).
In the STD guide published by the CDC, it is recommended to evaluate the people who constitute the risk group in the prevention of these diseases and to provide education and counseling (CDC, 2020). In this context, training to increase the level of knowledge and awareness of young people, who are one of the high-risk groups in society in terms of STD, is important in terms of reducing risky sexual behaviors, early diagnosis, and treatment.
Based on all these reasons; It is aimed to evaluate the effectiveness of sexual and reproductive health education given to university students.
Detailed description
During the International Conference on Population and Development held in Cairo in 1994, SRH was covered extensively for the first time and the scope of reproductive and sexual health was expanded (ICPD, 1994). If the concepts that make up the SRH of adolescents and young people are examined, the term sexual health is used to describe the absence of disease and disability related to sexuality and the sense of sexual well-being. It has been defined as a positive combination of the physical, emotional, intellectual, and social aspects of sexuality. Sexuality influences thoughts, feelings, interactions, and actions between individuals, motivating people to find love, contact, warmth, and intimacy. Sexuality can be expressed in many different ways and it has been determined that it is closely linked to the environment in which people live.
Reproductive health is defined as a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity in all matters related to the reproductive system, its functions and processes. Reproductive health therefore means that people can live a satisfying and safe sex life and have the freedom to decide when and how often to use their reproductive capacity. Men and women have the right to have access to safe, effective, affordable and acceptable methods of family planning, the right to be informed, and the right to access health services that will ensure a safe pregnancy and delivery, and the chance to have a healthy baby.
The scope of reproductive health includes methods, techniques and services that contribute to reproductive health and welfare by providing reproductive health care, preventing and solving reproductive health problems. The aim of reproductive health includes not only reproductive and STI-related counseling and care, but also sexual health, which is to improve life and personal relationships (WHO, 2006).Adolescents and young people, like all individuals, have the right to make decisions concerning their own bodies and to access services that support this right. Ensuring sexual and reproductive health for all depends on the realization of sexual and reproductive rights based on human rights (Engel et al., 2019).
Based on all these reasons; In this study, it is aimed to evaluate the effectiveness of sexual and reproductive health education given to university students.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-face Training Group | Experimental | Other: Face-to-face Training GroupStudents in this group will be given face-to-face training on SRH by the principal researcher accompanied by PowerPoint. |
| DataMatrix supported Face-to-face training group | Experimental | Other: DataMatrix supported Face-to-face training groupBefore starting the training, a QR code including PowerPoint on SRH will be given to the students in the group that receives training with QR code support (on the first slide). Students will be directed to the URL automatically determined by the researcher by scanning the QR code with the camera of their smartphones. Students will follow the lesson with the QR code given simultaneously with the training given during the education process. |
| Online training group | Experimental | Other: Online training groupThe students in the online training group will be given training on SRH/RES on an online platform accompanied by PowerPoint by the principal researcher. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Volunteering to participate in the research,
- Have not taken Sexual Health, Infectious Diseases course before
- Students without communication barriers will be included.
Key exclusion criteria (2 listed)
- Incorrect or incomplete form filling
- The participant's wish to withdraw from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face-to-face Training GroupThe training will take approximately 3 hours. The training will be done interactively, allowing students to talk to each other and ask questions, and will end with 10 minutes of time for students' questions. | Other | Face-to-face Training Group |
| DataMatrix supported Face-to-face training groupStudents will follow the lesson with the QR code given simultaneously with the training given during the education process. The training will be held in such a way that the students will be given the opportunity to ask questions and will end with 10 minutes of time to be given to the questions of the students. | Other | DataMatrix supported Face-to-face training group |
| Online training groupThe training will take approximately 3 hours. The training will be done interactively, allowing students to talk to each other and ask questions, and will end with 10 minutes of time for students' questions. | Other | Online training group |
Primary outcome
Participant Identification Form Diagnostic Form
Time frame: 5 Months
The participant identification form, which includes the introductory characteristics of the students, was prepared by the researchers in line with the literature (Altay et al., 2020; Vongxay et al., 2019). The form includes students' socio-demographic characteristics, their status of obtaining information about SRH and sources of information, their experiences with SRH and their thoughts on sexual intercourse. The form consists of 28 questions in total.
1 secondary outcome
Sexual Health Knowledge Test
Time frame: 5 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- A Package of Sexual and Reproductive Health and Rights Interventions-What Does It Mean for Adolescents?Link provided by the sponsor.
- What do we know about sexting, and when did we know it?Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba Öz principal investigator
ev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face Training Group, DataMatrix supported Face-to-face training group and Online training group in people with Reproductive Health and Sexual Health, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Identification Form Diagnostic Form (time frame: 5 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.