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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