Efficacy of Endocare Treatment at Home on Pain in Women With Chronic Pelvic-perineal Pain Related to Endometriosis. EndoHome.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Pain intensity change
研究概览
简要总结
Women with endometriosis experience recurrent pelvic-perineal pain impairing the quality of life, among other things. Endometriosis-related pain negatively impacts the sexual, family and work life.
Apart from the usual painkillers, the doctor's current therapeutic arsenal is limited to hormonal contraceptives and surgery. As endometriosis-related treatments do not currently address all of the patients' problems, developing a new, effective, non-pharmaceutical treatment would make it possible to relieve the pain of these women.
Endocare treatment consists of visual and auditory therapeutic procedures for pelvic-perineal pain in patients with endometriosis.
Moreover, as Endocare is not a pharmacological molecule but a digital therapy, it would not increase the consumption of pharmacological agents. An analgesic effect of Endocare lasting several hours on chronic pelvic-perineal pain associated with endometriosis is expected.
The effects of the treatment will be compare to a digital control also integrated in a virtual reality headset identical to the one distributing Endocare allowing to maintain the blindness to the patients and the investigator on the treatment received.
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
- Quadruple (Participant, Care Provider, 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 over 18 years of age with diagnosed endometriosis (histology, imaging, clinical symptomatology) and/or adenomyosis.
- •Women with at least 2 consecutive days per month of endometriosis-related pelvic-perineal pain of moderate to severe intensity (NS ≥ 4):
- •Women without amenorrhea: pain around the onset of menstruation.
- •Women with amenorrhea: most intense pain of the month.
排除标准
- •Pregnant or nursing women.
- •Women participating, or who have participated, in a clinical interventional study within 30 days prior to inclusion.
- •Women with severe visual, auditory or cognitive impairment, color blindness, photosensitivity, epilepsy or motion sickness.
- •Women whose pain is occasional and not present at each menstrual period.
- •Women who have previously received virtual reality treatments.
- •Women under judicial protection, guardianship, curatorship, protective mandate.
结局指标
主要结局
Pain intensity change
时间窗: Time points are before treatment (Time 0) and one hour after treatment (Time 1) during t five days (Day 1, Day 2, Day 3, Day 4, Day 5)
The mean change in pain intensity assessed by a numeric rating scale (pain intensity numerical scale) between the pre-treatment measurement and one hour after the use of Endocare treatment, compared to the digital control during the five days of treatment.The pain scale is a 11-point numeric scale (0=no pain; 10=unbearable pain).
次要结局
- Change in pain intensity(at wake-up and bedtime during the 5 days of treat (Day 1 to Day 5))
- Change in stress value(at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5))
- Pain relief treatments(during the five days of treatment (Day 1 to Day 5) at bedtime)
- Assessment of Clinical Global Impression of Improvement(through study completion (Day 6), an average of one week)
- Change in pain relief(At 1 hour (Time 1), 2 hours (Time 2) and 3 hours (Time 3) after treatment during the 5 days of treatment (Day 1 to Day 5))
- Assessment of the predictive value of dramatization and catastrophizing thoughts(At the inclusion visit Day 0)
- Incidence of adverse events and treatment adherence(during the five days of treatment (Day 1 to Day 5))
- Weighted average change in pain intensity(from pre-treatment (Time 0) to 2 hours (Time 2) and 3 hours (Time 3) post-treatment during the 5 days of treatment (Day 1 to Day 5))
- Change in fatigue value(at wake-up and bedtime during the 5 days of treatment (Day 1 to Day 5))
- Change in endometriosis-related quality of life(At inclusion visit Day 0 and at through study completion (Day 6), an average of one week)
- Assessment of satisfaction(through study completion (Day 6), an average of one week)