Comparison of the effects of surgical and pharmacological treatment on AFT, HRV, and NPRS in endometriosis patients: A prospective longitudinal study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- 1. To assess the changes in AFT among endometriosis patients’ surgical and pharmacological treatment groups.
研究概览
简要总结
This prospective longitudinal study aims to compare the effects of surgical and pharmacological treatment on autonomic function tests (AFT), heart rate variability (HRV), and numerical pain rating scale (NPRS) outcomes in women with endometriosis. Endometriosis, a chronic and painful gynecological condition, is often managed through either surgical intervention (laparoscopy) or pharmacological therapy (hormonal agents), but their comparative effects on physiological and pain-related outcomes are underexplored.
Ninety-two women aged 18–45 years, newly diagnosed with endometriosis and opting for either surgery or medical management, will be recruited. Participants will undergo baseline assessments for AFT, HRV, and NPRS, with follow-up evaluations at 1 month post-treatment. The study will not involve randomization; treatment decisions will be based on patient preference and clinical judgment.
Statistical analysis will include t-tests, ANOVA, and regression modeling to assess changes in autonomic function and pain perception between groups. The study aims to provide evidence-based insights into how different treatment modalities influence pain relief, autonomic balance, and overall physiological recovery, thus guiding personalized treatment strategies for women with endometriosis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients willing to undergo either surgical or pharmacological treatment.
- •Patients with no prior treatment for endometriosis within the past 6 months.
排除标准
- •Patients with comorbid systemic diseases (e.g., diabetes, hypertension).
- •Pregnant or lactating women.
- •Patients with a history of psychiatric disorders or autonomic dysfunction.
结局指标
主要结局
1. To assess the changes in AFT among endometriosis patients’ surgical and pharmacological treatment groups.
时间窗: 1. Baseline | 2. 12 weeks after initiation of treatment plan
2. To evaluate the HRV variations between the surgical and pharmacological treatment groups.
时间窗: 1. Baseline | 2. 12 weeks after initiation of treatment plan
3. To compare NPRS scores to determine the efficacy of pain management in the two groups.
时间窗: 1. Baseline | 2. 12 weeks after initiation of treatment plan
次要结局
- 1. To compare NPRS scores to determine the efficacy of pain management in the two groups.
研究者
Vishnu Balram
Kasturba Medical College Manipal