Health Risk BehaviorsNCT04579432
The Effect of Web Based Reproductive Health Education on Sexual Myths and Risky Behaviors in University Students
A study testing Education in people with Health Risk Behaviors and Reproductive Health, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The World Health Organization (WHO) defines the concept of reproductive health as "not only the absence of disease or disability, but a state of complete physical, mental and social welfare in all matters related to the reproductive system, functions and processes". Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Risk Behaviors, Reproductive Health, Sexual Health
- What is being tested?
- Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Mar 2021to 31 Oct 2021
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being a first year undergraduate / associate degree student
- Not taking any anatomy or women's health classes
- Volunteering to participate in research
- Being in the age range of 18-24
Who cannot join
- Voluntarily leaving the research
- Not attending the trainings given in the experimental group
Trial locations and contacts
1 site in 1 country.
About this study
The World Health Organization (WHO) defines the concept of reproductive health as "not only the absence of disease or disability, but a state of complete physical, mental and social welfare in all matters related to the reproductive system, functions and processes". However, it also emphasizes that people have free will in the timing of having a satisfying and safe sexual life and using their reproductive abilities.
Sexual and reproductive health and rights are essential for the health and survival of people, economic development and prosperity. In the United Nations 2030 Sustainable Development Goals, the third article named "Health and Quality Life" includes the targets covering reproductive health and sexual health. Some of these goals are; universal access to sexual and reproductive health services, creation of national education and information strategies for reproductive health, preventing sexually transmitted infections (STIs), access to information about family planning, and reducing maternal and neonatal mortality. People can lead a complete healthy and quality life only when these goals are achieved.
Read more
It is observed that the knowledge of men and women about general reproductive health and the organs and functions of the female and male reproductive systems is significantly lacking. In addition to these, it has been reported that they have insufficient knowledge on other issues such as sexual health, STIs and family planning methods. There are studies showing that lack of knowledge brings about reproductive health problems in young individuals. Problems such as exposure to STIs, early pregnancy, and risky sexual behaviors arise due to lack of information. Since all these health problems can cause permanent damage, the individual's future reproductive health is also at risk. However, it is possible to come across studies showing that reproductive health education is a tool to prevent these adverse health conditions. In a study conducted with university students, even if students' basic sexual education knowledge levels were good; It has been reported that there is a positive relationship between receiving sexual education and protective sexual behaviors, knowledge, motivation and skills. At the same time, it has been reported in many studies that believing in sexual myths, which are considered as false beliefs and have no scientific value, is more common in students with high levels of knowledge. While sexual myths cause behavioral changes with believed mistakes, sexual dysfunctions, decrease in sexual satisfaction and negative attitude towards contraceptive methods can also be brought about. Considering that people who know more about sexually transmitted HIV/AIDS have a low rate of believing in myths, an important reproductive health problem such as STI should be considered to be related to myths.
In this context, training on reproductive health and sexual health is important. Preparation and implementation of trainings on reproductive and sexual health by health professionals; It is important as it is known that young people have access to conflicting or incorrect information from various sources. Therefore, health professionals should be involved in these training processes. While planning the trainings, many platforms can be used, and nowadays, web-based trainings increase their importance with the introduction of the internet in all areas of our lives. The biggest advantages of web-based education are that it can be accessed anytime, anywhere and by anyone. In various studies conducted with university students, it is seen that web-based education increases the level of knowledge and is effective in behavior change.
In this period when technological education emerged, many instructional design models developed were used in web-based education. Among these models, the most widely used ADDIE model. ADDIE is a model that provides a systematic and comprehensive definition and implementation of design principles. The web-based training in the research will be given based on the ADDIE Model approach. Basic elements of the instructional design process in the model; It is in the form of Analysis, Design, Development, Implementation and Evaluation. The use of a model in web-designed education ensures that the educational content is prepared according to the needs, the training steps are not skipped and systematic.
In the literature review and web researches, a web-based education was not encountered in national and international publications where university students could reach the correct and scientific information about reproductive health. In this context, the investigators believe that web-based education to be provided with the ADDIE Model approach will reduce the sexual myths and risky behaviors that young people believe.
This study was planned to examine the effect of web-based reproductive health education given to university students on belief in sexual myths and risky behaviors.
- Conditions
- Health Risk Behaviors, Reproductive Health, Sexual Health
- Being tested
- Education
- Keywords
- Health Risk Behaviors, Reproductive Health, Sexual Health, Sexual Myths
- Medical subject headings
- Health Risk Behaviors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
With the training module prepared according to the ADDIE model, the intervention group will be trained on reproductive health and sexual health.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | Not described Receives: Other: Education |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
This form, which was prepared by the researchers by scanning the literature, in order to describe the sociodemographic and reproductive health information of the students participating in the study, and the platforms / individuals from which this information was obtained, consists of 20 questions.
Measured: Baseline (To both groups before the intervention)
Sexual Myths Scale
It is a scale developed to describe sexual myths scale by Gölbaşı et al. in 2016. The scale consists of 8 sub-dimensions and 28 items that allow the multidimensional evaluation of sexual myths.
Sub Dimensions and Item Numbers; Sexual orientation: 1-5. Articles, Gender: 6-11. Substances, Age and sexuality: 12-15. Substances, Sexual behavior: 16-18. Substances, Masturbation: 19-20. Sexual violence: 21-24. Substances, Sexual intercourse: 25-26. Substances, Sexual Satisfaction: 27-28. Substances. Each item of the scale is evaluated on a 5-point: "Never agree" = 1, "Disagree" = 2, "Undecided" = 3, "Partially Agree" = 4, "Strongly Agree" = 5. The total score for the scale is obtained by adding the scores given to each item. The minimum score obtained from the scale is 28 and the maximum score is 140. The scale does not have a cut-off point. The higher the score, the higher the sexual myths.
Measured: Change in believing sexual myths at Baseline and 5 weeks of education)
Information and Risky Behavior Form Specific to Reproductive Health Education
It is a form consisting of 47 questions created after the literature review. Contains; male and female anatomy and physiology, regulation of fertility, sexually transmitted infections and risky behaviors related to these issues. The items in the form consist of true and false statements that evaluate students' knowledge and attitudes about risky behaviors in the educational content. The questions in each item will be answered as "True, False, No Idea". The questions in the form will be submitted for expert opinion. A pre-test will be conducted to detect the presence of incomprehensible expressions. The score of the form will be calculated by giving 1 point to each correct answer and the highest score will be 47.
Measured: Change in risky behavior at Baseline and 5 weeks of education)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start8 Mar 2021
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Health Risk BehaviorsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is a control group and an experimental group in this research. Pre-test and post-test will be carried out with a pattern. A pre-test will be made to the control and experimental groups simultaneously. Then, the experimental group will be trained and the final test will be conducted simultaneously with the non-intervened control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güzin Ünlü, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579432
- Sponsor's protocol ID
- 58797649-050-
- Status last verified
- Apr 2022
- First submitted
- 28 Sep 2020
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aggarwal, A. K., & Bento, R. (2002). Web-based education. In Web-based instructional learning (pp. 59-77). IGI Global.
Ancheta R, Hynes C, Shrier LA. Reproductive health education and sexual risk among high-risk female adolescents and young adults. J Pediatr Adolesc Gynecol. 2005 Apr;18(2):105-11. doi: 10.1016/j.jpag.2005.01.005.
PubMed 15897107Apay, S. E., Akpınar, R. B., & Arslan, S. (2013). Öğrencilerin cinsel mitlerinin incelenmesi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 16(2), 96-102.
Apay, S. E., Nagorska, M., Akpınar, R. B., Celik, A. S., & Binkowska-Bury, M. (2013). Student comparison of sexual myths: two-country case. Sexuality and Disability, 31(3), 249-262.
Aronowitz T, Lambert CA, Davidoff S. The role of rape myth acceptance in the social norms regarding sexual behavior among college students. J Community Health Nurs. 2012;29(3):173-82. doi: 10.1080/07370016.2012.697852.
PubMed 22857406Aygin, D., Açıl, H., Yaman, Ö., & Çelik Yılmaz, A. (2017). Üniversitede okuyan kadın öğrencilerin cinsel mitler ile ilgili görüşleri. Androloji Bülteni, 19(2), 44-49.
Baghaie, R., Rasouli, D., Rahmani, A., Mohammadpour, Y., & Jafarizade, H. (2012). Effect of web-based education on cardiac disrhythmia learning in nursing student of Urmia University of Medical Sciences. Iranian Journal of Medical Education, 12(4), 240-248.
Çetin, Ö., & Aslan, E. (2019) Adölesanlarda Sık Görülen Jinekolojik Sorunlar. Sağlık Bilimlerinde İleri Araştırmalar Dergisi, (2), 33-43.
Duan YP, Wienert J, Hu C, Si GY, Lippke S. Web-Based Intervention for Physical Activity and Fruit and Vegetable Intake Among Chinese University Students: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 10;19(4):e106. doi: 10.2196/jmir.7152.
PubMed 28396306Gölbaşı, Z. (2005). Adölesan Dönem Üreme Sağlığı Sorunları Ve Etkileyen Faktörler. Anadolu Hemşirelik Ve Sağlık Bilimleri Dergisi, 8(1), 100-108.
İpek, İ., Sözcü, Ö. F., & Ziatdinov, R. (2013). Birleştirilmiş E-Öğrenme Tasarımı Modeli ve Hızlı Öğretim Tasarımı Stratejileri. Akademik Bilişim Konferansı, Akdeniz Üniversitesi Hukuk Fakültesi Antalya-Türkiye (http://ab. org. tr/ab13/bildiri/).
Kalembo, F. W., Zgambo, M., & Yukai, D. (2013). Effective adolescent sexual and reproductive health education programs in sub-Saharan Africa. Californian Journal of Health Promotion, 11(2), 32-42.
Kukulu, K., Gürsoy, E., & Sözer, G. A. (2009). Turkish university students' beliefs in sexual myths. Sexuality and Disability, 27(1), 49-59.
Michie L, Cameron ST, Glasier A, Wellings K, Loudon J. Myths and misconceptions about intrauterine contraception among women seeking termination of pregnancy. J Fam Plann Reprod Health Care. 2014 Jan;40(1):36-40. doi: 10.1136/jfprhc-2012-100497. Epub 2013 May 24.
PubMed 23709608Moradi, A., Salimi, M., Esfarjani, S. V., & Haghighizadeh, M. H. (2017). Effect of Web-based education on knowledge and preventive behaviors of Iron Deficiency Anemia among high school girls. Journal of Clinical and Analytical Medicine, 1, 445.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Web Based Reproductive Health Education on Sexual Myths and Risky Behaviors in University Students
- ClinicalTrials.gov ID
- NCT04579432
- Acronym / sponsor ID
- 58797649-050-
- Conditions
- Health Risk Behaviors, Reproductive Health, Sexual Health
- Keywords
- Health Risk Behaviors, Reproductive Health, Sexual Health, Sexual Myths
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 8 Oct 2020 (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 World Health Organization (WHO) defines the concept of reproductive health as "not only the absence of disease or disability, but a state of complete physical, mental and social welfare in all matters related to the reproductive system, functions and processes". However, it also emphasizes that people have free will in the timing of having a satisfying and safe sexual life and using their reproductive abilities.
Sexual and reproductive health and rights are essential for the health and survival of people, economic development and prosperity. In the United Nations 2030 Sustainable Development Goals, the third article named "Health and Quality Life" includes the targets covering reproductive health and sexual health. Some of these goals are; universal access to sexual and reproductive health services, creation of national education and information strategies for reproductive health, preventing sexually transmitted infections (STIs), access to information about family planning, and reducing maternal and neonatal mortality. People can lead a complete healthy and quality life only when these goals are achieved.
It is observed that the knowledge of men and women about general reproductive health and the organs and functions of the female and male reproductive systems is significantly lacking. In addition to these, it has been reported that they have insufficient knowledge on other issues such as sexual health, STIs and family planning methods. There are studies showing that lack of knowledge brings about reproductive health problems in young individuals. Problems such as exposure to STIs, early pregnancy, and risky sexual behaviors arise due to lack of information. Since all these health problems can cause permanent damage, the individual's future reproductive health is also at risk. However, it is possible to come across studies showing that reproductive health education is a tool to prevent these adverse health conditions. In a study conducted with university students, even if students' basic sexual education knowledge levels were good; It has been reported that there is a positive relationship between receiving sexual education and protective sexual behaviors, knowledge, motivation and skills. At the same time, it has been reported in many studies that believing in sexual myths, which are considered as false beliefs and have no scientific value, is more common in students with high levels of knowledge. While sexual myths cause behavioral changes with believed mistakes, sexual dysfunctions, decrease in sexual satisfaction and negative attitude towards contraceptive methods can also be brought about. Considering that people who know more about sexually transmitted HIV/AIDS have a low rate of believing in myths, an important reproductive health problem such as STI should be considered to be related to myths.
In this context, training on reproductive health and sexual health is important. Preparation and implementation of trainings on reproductive and sexual health by health professionals; It is important as it is known that young people have access to conflicting or incorrect information from various sources. Therefore, health professionals should be involved in these training processes. While planning the trainings, many platforms can be used, and nowadays, web-based trainings increase their importance with the introduction of the internet in all areas of our lives. The biggest advantages of web-based education are that it can be accessed anytime, anywhere and by anyone. In various studies conducted with university students, it is seen that web-based education increases the level of knowledge and is effective in behavior change.
In this period when technological education emerged, many instructional design models developed were used in web-based education. Among these models, the most widely used ADDIE model. ADDIE is a model that provides a systematic and comprehensive definition and implementation of design principles. The web-based training in the research will be given based on the ADDIE Model approach. Basic elements of the instructional design process in the model; It is in the form of Analysis, Design, Development, Implementation and Evaluation. The use of a model in web-designed education ensures that the educational content is prepared according to the needs, the training steps are not skipped and systematic.
In the literature review and web researches, a web-based education was not encountered in national and international publications where university students could reach the correct and scientific information about reproductive health. In this context, the investigators believe that web-based education to be provided with the ADDIE Model approach will reduce the sexual myths and risky behaviors that young people believe.
This study was planned to examine the effect of web-based reproductive health education given to university students on belief in sexual myths and risky behaviors.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There is a control group and an experimental group in this research. Pre-test and post-test will be carried out with a pattern. A pre-test will be made to the control and experimental groups simultaneously. Then, the experimental group will be trained and the final test will be conducted simultaneously with the non-intervened control group.
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Education |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being a first year undergraduate / associate degree student
- Not taking any anatomy or women's health classes
- Volunteering to participate in research
- Being in the age range of 18-24
Key exclusion criteria (2 listed)
- Voluntarily leaving the research
- Not attending the trainings given in the experimental group
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 |
|---|---|---|
| EducationWith the training module prepared according to the ADDIE model, the intervention group will be trained on reproductive health and sexual health. | Other | Training Group |
Primary outcome
Personal Information Form
Time frame: Baseline (To both groups before the intervention)
This form, which was prepared by the researchers by scanning the literature, in order to describe the sociodemographic and reproductive health information of the students participating in the study, and the platforms / individuals from which this information was obtained, consists of 20 questions.
Sexual Myths Scale
Time frame: Change in believing sexual myths at Baseline and 5 weeks of education)
It is a scale developed to describe sexual myths scale by Gölbaşı et al. in 2016. The scale consists of 8 sub-dimensions and 28 items that allow the multidimensional evaluation of sexual myths. Sub Dimensions and Item Numbers; Sexual orientation: 1-5. Articles, Gender: 6-11. Substances, Age and sexuality: 12-15. Substances, Sexual behavior: 16-18. Substances, Masturbation: 19-20. Sexual violence: 21-24. Substances, Sexual intercourse: 25-26. Substances, Sexual Satisfaction: 27-28. Substances. Each item of the scale is evaluated on a 5-point: "Never agree" = 1, "Disagree" = 2, "Undecided" = 3, "Partially Agree" = 4, "Strongly Agree" = 5. The total score for the scale is obtained by adding the scores given to each item. The minimum score obtained from the scale is 28 and the maximum score is 140. The scale does not have a cut-off point. The higher the score, the higher the sexual myths.
Information and Risky Behavior Form Specific to Reproductive Health Education
Time frame: Change in risky behavior at Baseline and 5 weeks of education)
It is a form consisting of 47 questions created after the literature review. Contains; male and female anatomy and physiology, regulation of fertility, sexually transmitted infections and risky behaviors related to these issues. The items in the form consist of true and false statements that evaluate students' knowledge and attitudes about risky behaviors in the educational content. The questions in each item will be answered as "True, False, No Idea". The questions in the form will be submitted for expert opinion. A pre-test will be conducted to detect the presence of incomprehensible expressions. The score of the form will be calculated by giving 1 point to each correct answer and the highest score will be 47.
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 20 Apr 2022.
- BackgroundAggarwal, A. K., & Bento, R. (2002). Web-based education. In Web-based instructional learning (pp. 59-77). IGI Global.
- Background: PubMed 15897107Ancheta R, Hynes C, Shrier LA. Reproductive health education and sexual risk among high-risk female adolescents and young adults. J Pediatr Adolesc Gynecol. 2005 Apr;18(2):105-11. doi: 10.1016/j.jpag.2005.01.005.
- BackgroundApay, S. E., Akpınar, R. B., & Arslan, S. (2013). Öğrencilerin cinsel mitlerinin incelenmesi. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 16(2), 96-102.
- BackgroundApay, S. E., Nagorska, M., Akpınar, R. B., Celik, A. S., & Binkowska-Bury, M. (2013). Student comparison of sexual myths: two-country case. Sexuality and Disability, 31(3), 249-262.
- Background: PubMed 22857406Aronowitz T, Lambert CA, Davidoff S. The role of rape myth acceptance in the social norms regarding sexual behavior among college students. J Community Health Nurs. 2012;29(3):173-82. doi: 10.1080/07370016.2012.697852.
- BackgroundAygin, D., Açıl, H., Yaman, Ö., & Çelik Yılmaz, A. (2017). Üniversitede okuyan kadın öğrencilerin cinsel mitler ile ilgili görüşleri. Androloji Bülteni, 19(2), 44-49.
- BackgroundBaghaie, R., Rasouli, D., Rahmani, A., Mohammadpour, Y., & Jafarizade, H. (2012). Effect of web-based education on cardiac disrhythmia learning in nursing student of Urmia University of Medical Sciences. Iranian Journal of Medical Education, 12(4), 240-248.
- BackgroundÇetin, Ö., & Aslan, E. (2019) Adölesanlarda Sık Görülen Jinekolojik Sorunlar. Sağlık Bilimlerinde İleri Araştırmalar Dergisi, (2), 33-43.
- Background: PubMed 28396306Duan YP, Wienert J, Hu C, Si GY, Lippke S. Web-Based Intervention for Physical Activity and Fruit and Vegetable Intake Among Chinese University Students: A Randomized Controlled Trial. J Med Internet Res. 2017 Apr 10;19(4):e106. doi: 10.2196/jmir.7152.
- BackgroundGölbaşı, Z. (2005). Adölesan Dönem Üreme Sağlığı Sorunları Ve Etkileyen Faktörler. Anadolu Hemşirelik Ve Sağlık Bilimleri Dergisi, 8(1), 100-108.
- Backgroundİpek, İ., Sözcü, Ö. F., & Ziatdinov, R. (2013). Birleştirilmiş E-Öğrenme Tasarımı Modeli ve Hızlı Öğretim Tasarımı Stratejileri. Akademik Bilişim Konferansı, Akdeniz Üniversitesi Hukuk Fakültesi Antalya-Türkiye (http://ab. org. tr/ab13/bildiri/).
- BackgroundKalembo, F. W., Zgambo, M., & Yukai, D. (2013). Effective adolescent sexual and reproductive health education programs in sub-Saharan Africa. Californian Journal of Health Promotion, 11(2), 32-42.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Health Risk Behaviors and Reproductive Health, run by Istanbul University - Cerrahpasa 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 4 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 20 Apr 2022. 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?
Personal Information Form (time frame: Baseline (To both groups before the intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04579432, which also lists 26 linked publications.
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 20 Apr 2022.