Evaluation of Pain Relief in Patients Experiencing Endometriosis-related Pain and Treated With Endocare®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Mean pain intensity 60 minutes after the beginning of treatment
研究概览
简要总结
Endocare® treatment is a stand-alone software medical device, which is composed of a mobile application and an accessory VR headset, intended to mitigate the pain for patients prone to endometriosis.
详细描述
Endocare® treatment is a stand-alone software medical device, which is composed of a mobile application and an accessory VR headset, intended to mitigate the pain for patients prone to endometriosis.
Mitigation of pain is realized through sequences of treatments via audio and visual stimulations.
The Endocare® treatment's main functionality, which addressed the intended purpose, is conducting sequences for treatment to mitigate the pain sensed by the patient.
The software will allow mitigating the sensed pain through 3D Virtual Reality via sequences of environments. The software will emit through sequences of 3D environments, auditory and visual stimulations.
The medical device is a CE marked Class I device. Women suffering from endometriosis present recurrent pelvic pain impairing their quality of life. The endometriosis-related pain has pejorative repercussions on sexual, family and professional life. Currently, the physician armamentarium is limited to analgesics and non-steroid anti-inflammatory drugs to treat endometriosis-related pain. Endocare® treatment intends to relieve pain thanks to its action on central nervous system. This study will describe the evolution of pain in patients experiencing endometriosis-related pain after a single treatment of Endocare® or a digital control.
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
- None
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
- •Woman ≥ 18 years old
- •With a diagnosis of endometriosis
- •Willing to participate in the study and having signed the informed consent form
- •Suffering from a moderate-to-severe endometriosis-related pain ≥ 4 on numerical rating scale (NRS) at the time of inclusion
排除标准
- •Pregnant or breastfeeding woman
- •Woman having consumed painkillers within 8h prior inclusion
- •Woman participating in an interventional study or having participated in an interventional study within the 30 days before enrolment
- •Contraindication to Endocare® or digital control: patients with severe visual, hearing and/or cognitive impairments, patients with colour blindness, patients who are photo-sensitive or suffering from epilepsy or motion sickness
- •Woman being an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator
结局指标
主要结局
Mean pain intensity 60 minutes after the beginning of treatment
时间窗: 60 minutes after treatment
Pain assessment evaluated with numerical rating scale (NRS): Pain assessed by 11-point numerical rating scale (NRS): 0=no pain; 10=unbearable pain
次要结局
- Evaluate the maximum reduction in pain after Endocare® compared to the digital control(15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment)
- Evaluate the pain evolution after Endocare® compared to the digital control(baseline (before treatment), 15 minutes, 30 minutes, 45 minutes, and 240 minutes after treatment)
- Evaluate the pain relief after Endocare ® compared to the digital control(15 minutes, 30 minutes, 45 minutes, 60 minutes, 240 minutes after treatment)
- Evaluate the safety of Endocare® or the digital control(through study completion, at 240 minutes after treatment)
- Describe the women satisfaction toward Endocare® or the digital control(240 minutes after treatment)