Prevalence of Anxiety Disorders, Depression and Related Factors in Vietnamese Infertile Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 768
- 试验地点
- 1
- 主要终点
- The prevalence of anxiety disorders
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is a systemic neuro-endocrine-metabolic-reproductive disorder, common in women of reproductive age, affecting 21.27% of women worldwide and the rate of PCOS has been increasing over the past decade.
Women with PCOS have many health problems, including insulin resistance, hyperandrogenemia, and ovulation disorders. Moreover, PCOS is also associated with significant consequences such as increased risk of cardiovascular disease, glucose intolerance and diabetes mellitus (both type 2 and gestational), increased risk of endometrial hyperplasia and endometrial cancer and mental health disorders.
A meta-analysis of 57 studies has been reported that women with PCOS are more likely to have an increased risk of diagnosis of depression, anxiety, bipolar disorder, and obsessive-compulsive disorder.
These psychological disorders may be related to biometric and biochemical characteristics in women with PCOS, such as body image, hirsutism or acne. Furthermore, researches showed that waist-to-hip ratio and plasmatic levels of testosterone is inversely related to anxiety, psychoticism, hostility and to the indexes of psychological distress. Psychological consequences may also be related to other factors, including stigmatization and isolation, the lack of empathy from family and friends, the feeling of guilt and the diminished sense of self-worth, the costs of treatment and treatment outcomes.
However, there has been no data on the psychological disorders in infertile women with PCOS. Therefore, the study aimed to determine the prevalence of anxiety disorders, depression in infertile women with PCOS and associated factors.
详细描述
- This trial will be conducted at My Duc Hospital, Ho Chi Minh City, Viet Nam.
- Women who are potentially eligible will be provided information about the study purposes, procedures, related risk and benefits
- Screening for eligibility will be performed on the day of the first visit when diagnosis about PCOS is established.
- Patients will be provided information related to the study together with the informed consent documents. Signed informed consent forms will be obtained by the investigators from all women before the enrolment.
- All patients selected for this study will answer the questionares and complete the GAD-7 GAD-7 (General Anxiety Disorder-7) and PHQ-9 (Patient Health Questionnaire-9) following careful instruction on how to complete the instrument by investigator in a private room without the presence of their husband.
- The survey will last about 15 minutes. If the result of the GAD-7 and PHQ-9 suggested anxiety disorders, depression, the patient will refer to specialists for further assessment and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile Vietnamese women
- •Reporting PCOS according to Rotterdam 2003
- •Agreement to participate in the study
排除标准
- •Having a family history of neuropsychiatric disease
- •Patients who are deaf, blind, or born dumb
- •Patents cannot understand Vietnamese
结局指标
主要结局
The prevalence of anxiety disorders
时间窗: immediately after the interview
The prevalence of anxiety disorders using General Anxiety Disorder-7 (GAD-7). The minimum values is 0 and maximum values is 21. Using cutoff score 10 with sensitivity 89% and specificity 82% for any anxiety disorder. Higher GAD-7 scores correlate with disability and functional impairment (in measures such as work productivity and health care utilization.
The prevalence of depression
时间窗: immediately after the interview
The prevalence of depression using Patient Health Questionnaire -9 (PHQ-9). The minimum values is 0 and maximum values is 27. PHQ-9 scores ≥10 were found to be 88% sensitive and also 88% specific for detecting major depressive disorder. Higher PHQ-9 scores are associated with decreased functional status and increased symptom-related difficulties, sick days, and healthcare utilization.
次要结局
未报告次要终点