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Trial Title: Polycystic Ovary Syndrome and Education

NCT ID: NCT06401850

Condition: Quality of Life

Conditions: Official terms:
Polycystic Ovary Syndrome

Conditions: Keywords:
Polycystic Ovary Syndrome
Quality of Life
Education

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Education Group
Description: 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.
Arm group label: Education Group

Intervention type: Other
Intervention name: Control Group
Description: 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.
Arm group label: Control Group

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 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.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Gender based: Yes

Gender description: Because PCOS occurs in women.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Marmara University

Address:
City: Istanbul
Zip: 34854
Country: Turkey

Status: Recruiting

Contact:
Last name: Rüveyda Ölmez Yalazı, PhDc

Phone: +905077243379
Email: ruveyda.olmezz@gmail.com

Start date: October 26, 2023

Completion date: June 30, 2024

Lead sponsor:
Agency: Marmara University
Agency class: Other

Source: Marmara University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06401850

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