Quality of LifeNCT06401850
Polycystic Ovary Syndrome and Education
A study testing Education Group in people with Quality of Life, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This research is being designed to determine the effect of Polycystic Ovary Syndrome (PCOS) education given to women on their quality of life. In this context, the aim of the project is; The aim is to determine the impact of the education given to women with PCOS on the quality of life of the training given to… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Quality of Life
- What is being tested?
- Education Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Oct 2023to 30 Jun 2024
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are over 18 years of age, open to communication, diagnosed with PCOS, have no mental problems that require treatment, have no physical, mental or five sense disabilities, speak Turkish and can read and write, and volunteer to participate in the study.
Who cannot join
- Individuals who are under 18 years old, not open to communication, diagnosed with PCOS, require treatment for significant mental health issues, have physical, mental, or sensory impairments, cannot speak or read and write Turkish, and are not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Marmara University
Istanbul, 34854
Rüveyda Ölmez Yalazı, PhDc, +905077243379, ruveyda.olmezz@gmail.com
About this study
Official title: Training Given to Women With Polycystic Ovary Syndrome Effect on Quality of Life: A Randomized Controlled Study
Aim: This research is being designed to determine the effect of Polycystic Ovary Syndrome (PCOS) education given to women on their quality of life. In this context, the aim of the project is; The aim is to determine the impact of the education given to women with PCOS on the quality of life of the training given to women with the disease, such as psychosocial and emotional status, fertility, sexual function, obesity and menstrual irregularity, and hair growth.
Method: Within the scope of this research, quantitative research method is used as the research method. In addition, it is planned as a randomized controlled quasi-experimental, which is one of the quantitative research methods. In calculating the sample size, type 1 error, research power and effect size parameters are determined before the research begins. Studies generally need to have at least 80% power. In order to find a significant difference, it is calculated that there should be at least 30 students in each group at 80% power and 95% confidence level. Considering the possible risks, it is planned to include 70 women in total in 2 groups (study and control), with 35 women in each group. All individuals who want to respond to the survey are included in the sample. The process of finding a subject continues until the desired size is reached. In addition, during the data collection process, participants were asked; They are asked whether they are diagnosed with PCOS and those who answer "yes" are included in the sample. Within the scope of the research, the voluntariness of the participants is essential and both written and verbal consents are obtained from each participant through an informed consent form. "Personal Information Form" and "Polycystic Ovary Syndrome Quality of Life-50 Scale" created by the researchers were used as data collection tools.
- Conditions
- Quality of Life
- Being tested
- Education Group, Control Group
- Keywords
- Polycystic Ovary Syndrome, Quality of Life, Education
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education GroupOther
The intervention provided to the training group focuses on improving skills to cope with polycystic ovary syndrome. This intervention includes topics such as encouraging healthy lifestyle habits, raising awareness about nutrition and exercise, teaching stress management techniques, and offering strategies to support hormonal balance. It provides participants with the tools they need to understand and manage symptoms that impact their lives. It also provides a supportive environment, encouraging participants to share their experiences with each other and receive support. This intervention aims to improve individuals' overall quality of life while strengthening their ability to manage their own health and well-being.
Control GroupOther
No intervention was made to the control group. This group did not receive additional training or support to cope with polycystic ovary syndrome. In this way, the effects of the control group on lifestyle, symptom management and overall quality of life were evaluated in comparison with the training group. This approach focuses on determining the direct effects of the intervention, while allowing to observe the natural course of the control group, and the results help to provide a clear assessment of the effectiveness of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Education Group | Experimental | Training for women with Polycystic Ovary Syndrome (POS) can play an important role in improving quality of life and managing symptoms. These trainings may cover topics such as healthy lifestyle choices, nutritional habits, exercise, stress management and strategies to support hormone balance. Acquiring these knowledge and skills can help women cope with POS, promote psychosocial recovery, and improve their overall quality of life. Receives: Other: Education Group |
| Control Group | Experimental | Since there was no training given to the control group, its effect on the participants' quality of life could not be evaluated. However, considering the potential of regularly provided training for women with polycystic ovary syndrome to improve quality of life, it may be important to provide similar training to the control group and compare the results. In this way, the effectiveness of training can be understood more clearly and the relationship between POS and quality of life can be evaluated more comprehensively. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life grade
To evaluate the impact on the quality of life of entrepreneurs. PCOS-50 standard questionnaires, one of the widely used scales, can be used to determine the quality of life of women with polycystic ovary syndrome. PCOS-50 allows participants to self-assess themselves in a variety of areas, including physical health, mental health, social functioning, pain, and general well-being. This scale is widely accepted for objectively assessing the impact of intervention on managing polycystic ovary syndrome symptoms and improving quality of life. This outcome measure provides a key criterion for evaluating the effectiveness of the intervention and enables outcomes to be measured in a scientifically valid and reliable manner.
Measured: before and 3 months after education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start26 Oct 2023
- Primary completion30 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rüveyda Ölmez Yalazı, PhDc, Principal investigator, Marmara UniversityNurdan Demirci, Prof, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401850
- Sponsor's protocol ID
- pcos
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Given to Women With Polycystic Ovary Syndrome Effect on Quality of Life: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06401850
- Acronym / sponsor ID
- pcos
- Conditions
- Quality of Life
- Keywords
- Polycystic Ovary Syndrome, Quality of Life, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 7 May 2024 (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: This research is being designed to determine the effect of Polycystic Ovary Syndrome (PCOS) education given to women on their quality of life. In this context, the aim of the project is; The aim is to determine the impact of the education given to women with PCOS on the quality of life of the training given to women with the disease, such as psychosocial and emotional status, fertility, sexual function, obesity and menstrual irregularity, and hair growth.
Method: Within the scope of this research, quantitative research method is used as the research method. In addition, it is planned as a randomized controlled quasi-experimental, which is one of the quantitative research methods. In calculating the sample size, type 1 error, research power and effect size parameters are determined before the research begins. Studies generally need to have at least 80% power. In order to find a significant difference, it is calculated that there should be at least 30 students in each group at 80% power and 95% confidence level. Considering the possible risks, it is planned to include 70 women in total in 2 groups (study and control), with 35 women in each group. All individuals who want to respond to the survey are included in the sample. The process of finding a subject continues until the desired size is reached. In addition, during the data collection process, participants were asked; They are asked whether they are diagnosed with PCOS and those who answer "yes" are included in the sample. Within the scope of the research, the voluntariness of the participants is essential and both written and verbal consents are obtained from each participant through an informed consent form. "Personal Information Form" and "Polycystic Ovary Syndrome Quality of Life-50 Scale" created by the researchers were used as data collection tools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education Group | Experimental | Other: Education GroupTraining for women with Polycystic Ovary Syndrome (POS) can play an important role in improving quality of life and managing symptoms. These trainings may cover topics such as healthy lifestyle choices, nutritional habits, exercise, stress management and strategies to support hormone balance. Acquiring these knowledge and skills can help women cope with POS, promote psychosocial recovery, and improve their overall quality of life. |
| Control Group | Experimental | Other: Control GroupSince there was no training given to the control group, its effect on the participants' quality of life could not be evaluated. However, considering the potential of regularly provided training for women with polycystic ovary syndrome to improve quality of life, it may be important to provide similar training to the control group and compare the results. In this way, the effectiveness of training can be understood more clearly and the relationship between POS and quality of life can be evaluated more comprehensively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who are over 18 years of age, open to communication, diagnosed with PCOS, have no mental problems that require treatment, have no physical, mental or five sense disabilities, speak Turkish and can read and write, and volunteer to participate in the study.
Key exclusion criteria (1 listed)
- Individuals who are under 18 years old, not open to communication, diagnosed with PCOS, require treatment for significant mental health issues, have physical, mental, or sensory impairments, cannot speak or read and write Turkish, and are not willing to participate in 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 |
|---|---|---|
| Education GroupThe intervention provided to the training group focuses on improving skills to cope with polycystic ovary syndrome. This intervention includes topics such as encouraging healthy lifestyle habits, raising awareness about nutrition and exercise, teaching stress management techniques, and offering strategies to support hormonal balance. It provides participants with the tools they need to understand and manage symptoms that impact their lives. It also provides a supportive environment, encouraging participants to share their experiences with each other and receive support. This intervention aims to improve individuals' overall quality of life while strengthening their ability to manage their own health and well-being. | Other | Education Group |
| Control GroupNo intervention was made to the control group. This group did not receive additional training or support to cope with polycystic ovary syndrome. In this way, the effects of the control group on lifestyle, symptom management and overall quality of life were evaluated in comparison with the training group. This approach focuses on determining the direct effects of the intervention, while allowing to observe the natural course of the control group, and the results help to provide a clear assessment of the effectiveness of the intervention. | Other | Control Group |
Primary outcome
Quality of life grade
Time frame: before and 3 months after education
To evaluate the impact on the quality of life of entrepreneurs. PCOS-50 standard questionnaires, one of the widely used scales, can be used to determine the quality of life of women with polycystic ovary syndrome. PCOS-50 allows participants to self-assess themselves in a variety of areas, including physical health, mental health, social functioning, pain, and general well-being. This scale is widely accepted for objectively assessing the impact of intervention on managing polycystic ovary syndrome symptoms and improving quality of life. This outcome measure provides a key criterion for evaluating the effectiveness of the intervention and enables outcomes to be measured in a scientifically valid and reliable manner.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- 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.
Rüveyda Ölmez Yalazı, PhDc principal investigator
Marmara University
Nurdan Demirci, Prof study director
Marmara 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 Education Group in people with Quality of Life, 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 1 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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rüveyda ölmez yalazı, PhDc (05077243379, ruveyda.olmezz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life grade (time frame: before and 3 months after education). 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 21 May 2024.