Acupuncture in Premenopausal Women With Hypoactive Sexual Desire Disorder: A Prospective Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Female Sexual Function Index (FSFI)
研究概览
简要总结
Female Sexual Dysfunction (FSD) affects up to 43% of women in the United States and Hypoactive Sexual Desire Disorder (HSDD) is the most common form. There is no standardized treatment for this condition. We know that alternative therapies such as acupuncture have been beneficial to women suffering from urinary incontinence, chronic lower back pain, and migraines. We hypothesize that the quality of life for premenopausal women with hypoactive sexual desire disorder (HSDD) will improve with initiation of acupuncture therapy for a duration of 5-weeks. Validated questionnaires are administered at the time of enrollment and 1 week after the final acupuncture session as the method of analyzing our primary outcome.
详细描述
Each woman will receive experimental therapy with acupuncture twice a week for five weeks and complete a packet of validated questionnaires/surveys at the 1st visit in person and at week 6 by mail.
The acupuncture sessions include:
- An Initial Evaluation in which the certified acupuncturist will take a
- History including: chief complaint, diet, level of diaphoresis, water intake, digestive function, menstrual cycling, sleep habits, overall mood
- Physical Exam: inspection of tongue and palpation of pulse
- 25 minutes of resting quietly with acupuncture needles in place
- Needle usage: from8 to 20 needles are typically used, with an average of 14 per session
- Needles are typically placed on the scalp, lower abdomen, elbows and knees
Subsequent Sessions (9 more) with the certified acupuncturist
- 25 minute each, twice weekly, for 5 weeks = total 10 sessions
- Needle usage = 8-20, average 14 per session
- Typically placed on the scalp, lower abdomen, elbows and knees
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
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-55 years
- •Sexually Active
- •Premenopausal
- •Documented diagnosis of HSDD as primary cause of FSD (defined as a non adjusted score of ≤ 6 in the desire domain of the FSFI questionnaire)
排除标准
- •Postmenopausal, defined as absence of menstruation in the prior 12 months
- •Pain or dyspareunia as the primary cause of FSD (defined as a non adjusted score of ≤ 6 in the pain domain of the FSFI)
- •History of hysterectomy and/or oophorectomy
- •History of chemotherapy, or pelvic irradiation
- •Use of hormonal contraception or oral hormone replacement therapy
- •Active skin infection or disease
- •Blood dyscrasia
- •Allergy to acupuncture needles
结局指标
主要结局
Female Sexual Function Index (FSFI)
时间窗: 6 weeks
Determined by a change in the desire domain of the Female Sexual Function Index (FSFI) from baseline at enrollment to study completion at 6 weeks after initiation of intervention.
次要结局
- Female Sexual Distress Scale (FSDS-R)(6 weeks)
- Short Form-12 (SF-12)(6 weeks)
- World Health Organization Quality of Life- BREF (WHOQOL)(6 weeks)
- Patient Global Impression of Improvement (PGI-I)(6 weeks)
- Generalized Anxiety-Disorder-7 (GAD-7) and Prime Health Questionnaire-9 (PHQ-9)(6 weeks)