Efficacy of Yoga on Symptom Severity and Quality of Life of Patients Suffering from Pain Predominant Medically Unexplained Physical Symptoms (MUPS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1. Reduction in PHQ-15 scores from recorded baseline 2. Reduction in the WHODAS 2.0 score from recorded baseline 3. Improvement in WHOQOL score from previously recorded baseline
研究概览
简要总结
This project is a randomized clinical trial to assess the efficacy of yoga on symptom severity and quality of life of patients suffering from Pain Predominant Medically Unexplained Physical Symptoms (with PHQ15>18 and pain lasting for more than 3months). After ruling out any underlying psychiatric illness Patients will be randomised into 2 groups with 1st group receiving only standard pharmacological interventions and the second group receiving yoga(for 12 weeks) in addition to pharmacological interventions. Patients baseline characteristics will be recorded using PHQ15(for severity of physical symptoms) , WHODAS and WHOQOL BREF(Quality of life and disability) and the same will be compared post intervention at 6weeks and 12weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with pain predominant medically unexplained physical symptoms (MUPS) with age group of 18- 60 years attending the OPD 2.Persistent pain (at least three months, continuously on most days) severe and distressing pain, in any part of the body.
- •Patients with initial PHQ score of at least 18
- •Residing within Delhi NCR and willing to follow up as per protocol
- •Willing to give written consent for participation in the study.
排除标准
- •Age<18 years 2.Not suffering from any major psychiatric illness.
结局指标
主要结局
1. Reduction in PHQ-15 scores from recorded baseline 2. Reduction in the WHODAS 2.0 score from recorded baseline 3. Improvement in WHOQOL score from previously recorded baseline
时间窗: Follow up with scoring questionnaires will be done on 6weeks and at 12weeks.
次要结局
- To assess socioeconomic correlates of the patients with medically unexplained physical symptoms .(Data recorded at baseline but analysed at the end of the study independent of the other primary outcome determinants)