Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)
研究概览
简要总结
This study is examining impact of pain on daily life, the ability to function and treatments used for patients with interstitial cystitis/painful bladder syndrome before and after a program of mindfulness and yoga, in comparison to patients who are undergoing treatment with their providers.
详细描述
This is a randomized control trial comparing women diagnosed with interstitial cystitis/painful bladder syndrome (ICPBS) receiving usual ICPBS care to those treated with usual care supplemented with meditation and yoga. Both groups continued their current ICPBS treatment regimens. Participants in the intervention group additionally received a commercially available meditation application and a yoga tutorial video. Women in either group were followed weekly for three months. Validated questionnaires were used to compare treatment response from baseline to 12 weeks of intervention for both groups. The primary outcome was the patient report on the global response assessment (GRA), and we required a sample size of 82 patients (41 per group) to detect a difference of 30% with a 10% margin of error (alpha of 0.05) with 80% power. Other questionnaires collected included the PROMIS pain interference scale, the interstitial cystitis problem index and symptom index (ICPI and ICSI), the VAS pain scale, treatment compliance, and treatment escalation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •>=Age 18
- •IC/BPS diagnosis
- •English or Spanish reading/writing
- •Own a Smartphone and able to watch online yoga tutorials
- •Ability/willingness to participate in follow up questionnaires
- •ICSI/ICPI >6 at baseline
- •Physical exam in the past 2 years by urogynecology or gynecologist
排除标准
- •Pregnancy or lactating
- •Inability to speak/write in English/Spanish
- •Known history of recurrent UTI
- •Urinary retention ( PVR>150 ml)
- •History of augmentation cystoplasty or urinary diversion.
- •History of chemotherapy/radiation or radiation induced cystitis
- •Hunner's Ulcers demonstrated in last 6 months by cystoscopy
- •Parkinsonism with neurogenic bladder
- •Multiple Sclerosis with neurogenic bladder
- •CVA with residual deficits
- •Patients with severe mobility impairment and inability to perform yoga postures
- •Patients who are hard of hearing or visually impaired
- •Imprisoned patients
结局指标
主要结局
Number of Participants Designated as "Treatment Responders" Based on Global Response Assessment (GRA)
时间窗: 3 months
This is a validated single question that determines treatment response. Participants were considered "treatment responders" if they answered "markedly improved/moderately improved" on the GRA at 12 weeks.
次要结局
- O'Leary-Sant: Interstitial Cystitis Symptom Index(change from baseline to 3 months)
- Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale(change from baseline to 3 months)
- O'Leary-Sant: Interstitial Cystitis Problem Index(change from baseline to 3 months)
- Pain VAS Score(change from baseline to 3 months)
- Hospital Anxiety and Depression Scale (HADS) Depression Subscale(change from baseline to 3 months)
- PROMIS Pain Interference Score(change froom baseline to 3 months)
- Pain Self-efficacy-2 Score(change from baseline to 3 months)