NCT04615247已完成不适用
A Feasibility Trial of a Group Based Yoga Intervention for Chronic Pelvic Pain in Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Number of Randomized Participants Who: a) Are Retained at 8 Weeks, b) Attend at Least 75% of Intervention Classes, c) Demonstrate at Least Moderate Intervention Self-efficacy, and d) Provide Pain Outcomes Data at 8 Weeks.
研究概览
简要总结
To refine and evaluate the feasibility of procedures for a future full-scale efficacy trial of a group-based therapeutic yoga intervention versus physical conditioning (stretching and strengthening) intervention for women with chronic pelvic pain.
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
- Double (Investigator, 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
- •Women aged 18 years or older who report chronic or recurrent pelvic pain for at least 6 months
- •Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale) on a screening 7-day pain log
- •Report prior clinical evaluation of pain by a healthcare professional including at least a superficial pelvic exam
- •Willing to refrain from initiating new clinical treatments that may affect their pain during the study period
排除标准
- •Report pelvic pain occurring exclusively with menses or exclusively during sexual intercourse (note that women with at least some pain between menses or intercourse are still eligible)
- •Participation in organized yoga classes or muscle strengthening programs (e.g., Pilates) in the past month, or prior yoga therapy specifically directed a pelvic pain
- •Currently pregnant (by self-report or screening test), pregnant within the past 6 months, or planning pregnancy
- •Diagnosed with an alternate, reversible cause of pain that is unlikely to respond to yoga and requires another treatment modality (e.g., current pelvic infection or a gynecologic dermatosis)
- •Initiation, dose escalation, or weaning of pharmacologic agents that may affect pelvic pain severity in the past 1 month (e.g., pain medications, antidepressants, anticonvulsants)-note that women on stable doses will be eligible
- •Surgery to the genital or pelvic structures within 3 months, or prior cancer or irradiation to these structures
- •Use of formal psychological therapies specifically for pelvic pain (e.g., systematic desensitization, sex therapy, cognitive therapy, relaxation therapy) within 1 month of screening
- •Use of formal behavioral therapies for pelvic or genital pain (e.g., pelvic floor rehabilitation or biofeedback performed by a certified healthcare practitioner) within 1 month of screening
- •Unable to walk up a flight of stairs or at least 2 blocks on level ground (i.e., functional capacity < 4 METs), or unable to get up from a supine to a standing position without assistance
- •Participation in another interventional study that might interfere with or confound study procedures
- •Known conflict with multiple available intervention class dates
- •Inability to sign an informed consent or fill out questionnaires or complete study interviews in English, or lacking technical requirements to complete intervention classes or study visits by video
结局指标
主要结局
Number of Randomized Participants Who: a) Are Retained at 8 Weeks, b) Attend at Least 75% of Intervention Classes, c) Demonstrate at Least Moderate Intervention Self-efficacy, and d) Provide Pain Outcomes Data at 8 Weeks.
时间窗: 8 weeks
Number of randomized participants who: a) are retained at 8 weeks, b) attend at least 75% of intervention classes, c) demonstrate at least moderate intervention self-efficacy, and d) provide pain outcomes data at 8 weeks.
次要结局
- Percentage of Screenees Who Are Eventually Randomized(Randomization)
- Percentage of Non-drop-outs Completing at Least 75% of Intervention Classes Over 8 Weeks(8 weeks)
- Percentage of Participants With Expected Pelvic Pain Impact Measures Returned at 8 Weeks(8 weeks)
- Percentage of Randomized Participants Who Drop Out by 8 Weeks(8 weeks)
- Percentage of Participants With at Least Moderate Self-efficacy in Performing Postures/Exercises at 8 Weeks(8 weeks)
- Percentage of Non-drop-outs Completing at Least 75% of Home Intervention Practice Over 8 Weeks(8 weeks)
- Percentage of Participants With Expected Pain Interference Questionnaires Returned at 8 Weeks(8 weeks)
- Percentage of Participants Rated by a Consultant as Being at Least Moderately Competent in Performing Postures/Exercises at 8 Weeks(8 weeks)
- Percentage of Participants With Expected Pain Logs Returned at 8 Weeks(8 weeks)
研究者
研究点 (5)
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