Polycystic Ovary Syndrome and Education

NCT ID: NCT06401850

Last Updated: 2024-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-26

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Education Group

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.

Group Type EXPERIMENTAL

Education Group

Intervention Type OTHER

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 Group

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.

Group Type EXPERIMENTAL

Control Group

Intervention Type OTHER

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.

Interventions

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Education Group

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.

Intervention Type OTHER

Control Group

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rüveyda Ölmez Yalazı, PhDc

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Nurdan Demirci, Prof

Role: STUDY_DIRECTOR

Marmara University

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Rüveyda ölmez yalazı, PhDc

Role: CONTACT

05077243379

Facility Contacts

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Rüveyda Ölmez Yalazı, PhDc

Role: primary

+905077243379

Other Identifiers

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pcos

Identifier Type: -

Identifier Source: org_study_id

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