NCT02261740已完成不适用
Program to Overcome Pelvic Pain With Yoga (POPPY) (a.k.a., Development of a Therapeutic Yoga Program for Female Genito-Pelvic Pain)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change from baseline in severity of pelvic pain after yoga therapy program.
研究概览
简要总结
The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report persistent or recurrent pelvic or genital pain for at least 6 months that interferes with sexual activity will be recruited from the San Francisco Bay Area. Those who meet eligibility criteria will take part in a 6-week yoga therapy program designed by an expert yoga panel. Women will attend twice-weekly group classes focusing on Iyengar-based yoga techniques that have been carefully selected for their potential to improve women's genito-pelvic pain and practice yoga at home one additional hour a week.
The investigators will evaluate changes in the severity and impact of women's pain using validated questionnaires and diaries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 21 years or older who report difficulties with pelvic or genital pain for at least 6 months
- •Report that their chronic pelvic or genital pain has had an adverse effect on their interest in or ability to enjoy sexual activity
- •Report an eligible average daily pain intensity score after completion of a Daily Pain Log for one week prior to baseline
- •Have an established primary care or gynecologic healthcare provider (to facilitate medical follow-up of any health issues detected incidentally in the study or adverse events that develop during the study)
- •Report prior clinical evaluation of their pelvic or genital pain by a health care professional including at least a superficial pelvic exam
- •Willing to refrain from initiating other new clinical treatments that may affect their pelvic or genital pain during the study period (6 weeks)
排除标准
- •Participation in organized yoga classes in the past 1 month, or any prior yoga therapy directed specifically at pelvic or genital pain (regardless of timing)
- •Currently pregnant (by self-report or screening test), pregnant within the past 6 months, planning pregnancy during the study, or unwilling to use contraception (if not postmenopausal) during the study
- •Diagnosed with an alternate cause of pain that is unlikely to respond to yoga and requires another treatment modality, such as pelvic infection or a gynecologic dermatosis
- •Surgery to the vulva, vagina, cervix, or pelvic organs within 6 months of screening, or any prior history of cancer or irradiation to these structures
- •Initiation of or dose escalation of pharmacologic agents that may affect pelvic or genital pain in the past 1 month (e.g., antidepressants, anticonvulsants, anxiolytics)-women on stable dose for >1 month are eligible
- •Use of formal psychological therapies specifically for pelvic or genital 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 in <10 seconds
- •Currently involved in a malpractice suit or other litigation specifically related to pelvic or genital pain
- •Participation in another interventional study that might interfere with or confound study procedures, inability to sign an informed consent or fill out questionnaires, or conflict with available yoga class dates
结局指标
主要结局
Change from baseline in severity of pelvic pain after yoga therapy program.
时间窗: Baseline to 6-Weeks
Self-reported daily pain severity, as rated by Daily Pain Log (scale from 0-10).
次要结局
- Change in baseline sexual functioning after yoga therapy program.(Baseline, 6-Weeks)
- Change in baseline quality of life after yoga therapy program.(Baseline, 6-Weeks)
研究者
研究点 (2)
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