SexualityNCT05770804
Young Women on Sexual and Reproductive Health Knowledge and Stigma Levels
A study testing Face to face education in people with Sexuality and Stigmatization, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Aim: Failure to exercise reproductive and sexual rights can increase the risk of unwanted pregnancies, HIV and sexually transmitted infections, sexual coercion and violence, especially in young women. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexuality, Stigmatization, Inflammation
- What is being tested?
- Face to face education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 25 Jan 2023
- 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 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Given to Young Women on Sexual and Reproductive Health Knowledge and Stigma Levels: A Randomized Controlled Study
Aim: Failure to exercise reproductive and sexual rights can increase the risk of unwanted pregnancies, HIV and sexually transmitted infections, sexual coercion and violence, especially in young women. All of these situations affect the physical and mental health of young girls, as well as the health of their families.For this reason, The Effect of Education Given to Young Women on Sexual and Reproductive Health Knowledge and Stigma Levels: A Randomized Controlled Study was planned.
Material and method: The research was conducted as a randomized controlled experimental study. The universe of the research consisted of female students studying at the Faculty of Health Sciences of Ağrı İbrahim Çeçen University between January and June 2022. The sample consisted of individuals who were studying at the Faculty of Health Sciences of Ağrı İbrahim Çeçen University between the same dates and who met the inclusion criteria of the research. "Descriptive Feature Form", "Sexual and Reproductive Health Stigma Scale for Young Women" and sexual health knowledge test were used to collect data. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman- Halton Exact test, paired samples test, t-test in independent groups, Friedman Test, One Way ANOVA test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.
- Conditions
- Sexuality, Stigmatization, Inflammation
- Being tested
- Face to face education
- Keywords
- sexual health, knowledge, Stigma
- Medical subject headings
- Sexuality, Stereotyping, Inflammation, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face to face educationBehavioural
Face-to-face training was provided and supported by booklets.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Face to face group Receives: Behavioral: Face to face education |
| Control Group | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Face to face group
- The Stigma of Sexual and Reproductive Health in Young Women Scale (SCASS): Hall et al. It was developed by in 2017 to identify the stigma of sexual and reproductive health in women aged 15-24. The original scale consists of 20 items and three sub-dimensions: Accepted stigma, Internalized Stigma, and Attitudes on which Stigma is Based. The accepted stigma sub-dimension consists of a total of 6 items. The lowest score that can be obtained from this dimension is 0, and the highest score is 7. The lowest score that can be obtained from the total of the scale is 0, and the highest score is 20. Each item of the scale is rated as 0=Disagree, 0=Neutral, 1=Agree. The higher the score, the higher the level of stigmatization. An increase in the score obtained from the scale indicates an increase in stigma. The Cronbach alpha value of the scale is 0.74. It is stated that the scale is suitable for all social classes.
Measured: 6 weeks
Face to face group
- 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. During the implementation of the CSBT, the participants are asked to carefully read each question and mark the answer they think is correct. Each answer marked correctly by the participant is scored as "1", and each answer marked incorrectly or left blank is scored as "0". The lowest score that can be obtained from CSBT is 0, and the highest score is 40. It is accepted that the higher the score, the higher the level of sexual health knowledge. The Cronbach alpha reliability coefficient of the test was found to be 0.88, and the internal consistency of the test was reported to be high reliability (Evcili \& Gölbaşı, 2017)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Jan 2022
- Primary completion1 Dec 2022
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SexualityStudies of the same condition, open and under way.
- More trials run by Sakarya 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metin Yildiz, Sakarya University
- Investigators
- Metin YILDIZ, Asst.Prof.Dr., Principal investigator, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770804
- Sponsor's protocol ID
- SakaryaU-metinyildiz-004
- Status last verified
- Oct 2023
- First submitted
- 2 Feb 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Given to Young Women on Sexual and Reproductive Health Knowledge and Stigma Levels: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05770804
- Acronym / sponsor ID
- SakaryaU-metinyildiz-004
- Conditions
- Sexuality, Stigmatization, Inflammation
- Keywords
- sexual health, knowledge, Stigma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 15 Mar 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.
Aim: Failure to exercise reproductive and sexual rights can increase the risk of unwanted pregnancies, HIV and sexually transmitted infections, sexual coercion and violence, especially in young women. All of these situations affect the physical and mental health of young girls, as well as the health of their families.For this reason, The Effect of Education Given to Young Women on Sexual and Reproductive Health Knowledge and Stigma Levels: A Randomized Controlled Study was planned.
Material and method: The research was conducted as a randomized controlled experimental study. The universe of the research consisted of female students studying at the Faculty of Health Sciences of Ağrı İbrahim Çeçen University between January and June 2022. The sample consisted of individuals who were studying at the Faculty of Health Sciences of Ağrı İbrahim Çeçen University between the same dates and who met the inclusion criteria of the research. "Descriptive Feature Form", "Sexual and Reproductive Health Stigma Scale for Young Women" and sexual health knowledge test were used to collect data. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman- Halton Exact test, paired samples test, t-test in independent groups, Friedman Test, One Way ANOVA test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) were used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Face to face educationFace to face group |
| Control Group | No intervention | –Control Group |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 educationFace-to-face training was provided and supported by booklets. | Behavioural | Intervention group |
Primary outcome
Face to face group
Time frame: 6 weeks
2. The Stigma of Sexual and Reproductive Health in Young Women Scale (SCASS): Hall et al. It was developed by in 2017 to identify the stigma of sexual and reproductive health in women aged 15-24. The original scale consists of 20 items and three sub-dimensions: Accepted stigma, Internalized Stigma, and Attitudes on which Stigma is Based. The accepted stigma sub-dimension consists of a total of 6 items. The lowest score that can be obtained from this dimension is 0, and the highest score is 7. The lowest score that can be obtained from the total of the scale is 0, and the highest score is 20. Each item of the scale is rated as 0=Disagree, 0=Neutral, 1=Agree. The higher the score, the higher the level of stigmatization. An increase in the score obtained from the scale indicates an increase in stigma. The Cronbach alpha value of the scale is 0.74. It is stated that the scale is suitable for all social classes.
Face to face group
Time frame: 6 weeks
3. 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. During the implementation of the CSBT, the participants are asked to carefully read each question and mark the answer they think is correct. Each answer marked correctly by the participant is scored as "1", and each answer marked incorrectly or left blank is scored as "0". The lowest score that can be obtained from CSBT is 0, and the highest score is 40. It is accepted that the higher the score, the higher the level of sexual health knowledge. The Cronbach alpha reliability coefficient of the test was found to be 0.88, and the internal consistency of the test was reported to be high reliability (Evcili \& Gölbaşı, 2017)
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 27 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Metin YILDIZ, Asst.Prof.Dr. principal investigator
Sakarya University
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 education in people with Sexuality and Stigmatization, run by Sakarya 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 0 inclusion and 1 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 27 Oct 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?
Face to face group (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 27 Oct 2023.