Prevalence rate and Predictors of Psychological Concerns in Patients with Trigeminal Neuralgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- To determine the prevalence of psychological comorbidities, namely anxiety, depression, sleep disturbances, and reduced quality of life, in patients with TN
研究概览
简要总结
This protocol outlines a prospective observational study at NIMHANS, Bengaluru, that will enroll patients diagnosed with trigeminal neuralgia to investigate the frequency and contributing factors for psychological concerns such as depression, anxiety, sleep disturbances, and impaired quality of life—using validated questionnaires that are PHQ 9, GAD 7, EuroQol 5D, PSQI at initial visit, 1month, 3months and 6months. The research does not involve any invasive procedures or additional risk instead, it aligns follow-up assessments with standard clinical care, with the final follow-up done by telephone to minimize inconvenience. Ethical safeguards are firmly in place, including informed consent, data confidentiality, and provisions for addressing distress identified during screenings. The ultimate goal is to improve awareness and management of psychological comorbidities in trigeminal neuralgia patients through systematic, ethically sound monitoring and identification of predictors.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Trigeminal Neuralgia of more than 6 weeks duration and BNI III, IV and V 2.Patients on at least 2 medications for the treatment of Trigeminal Neuralgia.
排除标准
- •1.Patients who have already undergone surgery for TN earlier 2.Patients with pre-existing psychiatric disorders 3.Patients with TN secondary to multiple sclerosis 4.Patient with other chronic pain syndromes.
结局指标
主要结局
To determine the prevalence of psychological comorbidities, namely anxiety, depression, sleep disturbances, and reduced quality of life, in patients with TN
时间窗: At First OPD visit, 1month, 3month and 6months
次要结局
- To identify clinical and sociodemographic predictors of psychological comorbidities in patients with Trigeminal Neuralgia(At First OPD visit, 1month, 3month and 6months)
- To evaluate the impact of different treatment modalities on the prevalence rate of psychological comorbidities by assessing changes in anxiety, depression, sleep disturbances, and quality of life from baseline (at presentation) to one-month, 3 months and 6 months post-treatment.(At First OPD visit, 1month, 3month and 6months)
研究者
Misbah Sadaf
National Institute of Mental Health and Neurosciences