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Clinical Trials/NCT06401850
NCT06401850
Recruiting
Not Applicable

Training Given to Women With Polycystic Ovary Syndrome Effect on Quality of Life: A Randomized Controlled Study

Marmara University1 site in 1 country70 target enrollmentOctober 26, 2023
ConditionsQuality of Life

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Marmara University
Enrollment
70
Locations
1
Primary Endpoint
Quality of life grade
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 26, 2023
End Date
June 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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