Assessment of Quality of Life and Psychological Factors Among Women Diagnosed With Gestational Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 206
- 试验地点
- 1
- 主要终点
- Quality of Life as measured by the Gestational Diabetes Mellitus Quality of Life Questionnaire (GDMQ-36)
研究概览
简要总结
Summary of Research Protocol
Title: Quality of Life and Associated Psychological Factors in Women with Gestational Diabetes Mellitus
Background:
Gestational Diabetes Mellitus (GDM) is a common metabolic disorder of pregnancy characterized by glucose intolerance first recognized during pregnancy. The prevalence of GDM is increasing globally and in India due to the rising burden of obesity and diabetes. While much research has focused on the physiological and obstetric consequences of GDM, its impact on quality of life (QoL) and psychological well-being remains less explored. Women diagnosed with GDM often experience anxiety, stress, fear regarding pregnancy outcomes, and concerns about their own and their baby's health, which may negatively affect their quality of life and adherence to treatment.
Research Gap:
Existing studies have primarily concentrated on glycemic control and pregnancy outcomes, with limited attention to the psychosocial dimensions of GDM. The relationship between quality of life and psychological factors such as anxiety, depression, stress, and social support among women with GDM has not been adequately studied, particularly in the Indian population.
Aim:
To assess the quality of life among women with Gestational Diabetes Mellitus and examine its association with psychological factors.
Objectives:
To study the quality of life in women with GDM. To compare the quality of life between pregnant women with GDM and those without GDM.
To assess associated psychological factors, including anxiety, depression, stress, and perceived social support, among women with GDM.
Methodology:
A comparative cross-sectional study will be conducted among pregnant women aged 20-40 years attending the OPD and IPD services of Christian Medical College & Hospital, Ludhiana. Women diagnosed with GDM according to DIPSI criteria (2-hour post 75 g oral glucose load blood sugar ≥140 mg/dL) will constitute the study group, while pregnant women without GDM will serve as controls.
Data regarding demographic characteristics, obstetric history, medical history, family history of diabetes, and socioeconomic status will be collected using a structured case record form. Socioeconomic status will be assessed using the Modified Kuppuswamy Scale.
Psychological assessment will include:
GAD-7 for anxiety symptoms. PHQ-9 for depressive symptoms. MSPSS for perceived social support.
Quality of life will be assessed using a validated QoL questionnaire appropriate for women with GDM.
Sample Size:
Based on previous literature, a minimum sample size of 103 participants in each group (GDM and non-GDM) has been calculated, resulting in a total sample size of 206 participants.
Statistical Analysis:
Data will be analyzed using SPSS version 26.0. Quantitative variables will be compared using Student's t-test or Mann-Whitney U test, while categorical variables will be analyzed using Chi-square or Fisher's exact test. A p-value <0.05 will be considered statistically significant.
Expected Outcome:
The study is expected to provide insights into the quality of life of women with GDM and identify psychological and social factors associated with poorer QoL. The findings may help healthcare providers develop holistic and patient-centered management strategies that address not only glycemic control but also the psychosocial needs of pregnant women with GDM.
详细描述
Diabetes is a major public health problem in India with prevalence rates reported to be between 4.6% and 14% in urban areas, and 1.7% and 13.2% in rural areas(1).
Gestational diabetes mellitus (GDM) is a transient metabolic disorder, characterized by hyperglycemia that occurs and is first diagnosed during pregnancy, and is expected to resolve after childbirth (2).
The onset of GDM puts a heavy strain on the positive connotation of pregnancy and is accompanied by feelings of fear, anxiety, uncertainty, a sense of losing control, elevated levels of stress, a poorer perception of one's health, reduced self-worth, and impaired QoL (3). Diabetes-specific instruments disregard the fact that women suffering from GDM expect their condition as temporarily limited to their pregnancy, unlike the chronic nature of diabetes mellitus type one or type two (4).
The usage of numerous different types of questionnaires for QoL assessment leads to inconsistent study findings on this topic, resulting in heterogeneous recommendations. Accordingly, it seems reasonable to establish a solid foundation for further research by developing and validating an appropriate patient-reported outcome measure for QoL assessments in GDM. Mokhlesi et al (5) have completed important work by introducing the Persian questionnaire GDMQ-36 for the assessment of disease-specific QoL in women with GDM, which has been proven to be reliable and valid for the Iranian population.
To our knowledge, it is so far the only questionnaire worldwide tailored to the QoL of gestational diabetics that incorporates all the mentioned aspects due to the fact that it is exactly tailored to the needs as well as disease- and treatment-related challenges gestational diabetics are facing. It contains 36 questions and consists of five aspects: (1) concerns about high-risk pregnancy, (2) perceived constraints, (3) complications of GDM, (4) medication and treatment, and (5) support In managing Gestational Diabetes Mellitus (GDM) is the lack of studies that explore how a
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •1) All Pregnant females admitted to Christian Medical College & Hospital, Ludhiana. (OPD+IPD).
- •2) Age group between 20-40 years.
- •3) Females who have given consent for the study.
排除标准
- •1) Subjects not willing to participate.
结局指标
主要结局
Quality of Life as measured by the Gestational Diabetes Mellitus Quality of Life Questionnaire (GDMQ-36)
时间窗: Baseline
Quality of life in women with Gestational Diabetes Mellitus (GDM) will be assessed using the disease-specific GDMQ-36 questionnaire. The questionnaire consists of 36 items across 5 domains: (1) concerns about high-risk pregnancy, (2) perceived constraints, (3) complications of GDM, (4) medication and treatment, and (5) support. Total score ranges from 0 to 100, with higher scores indicating better quality of life. This will be assessed in women with GDM at baseline.
次要结局
- Prevalence of Depressive Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline)
- Level of Perceived Social Support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)(Baseline)
- To assess the association of serum Vitamin D with Gestational Diabetes Mellitus.(Baseline)
- To assess the association of serum Cortisol levels with Gestational Diabetes Mellitus.(Baseline)
研究者
Harsh Kishore
PhD scholar
Lovely Professional University