ENDOREV: A Solution to Reduce Anxiety During Gynecological Consultations in Patients With Suspected Endometriosis?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Number of participants showing a reduction in post-consultation anxiety
研究概览
简要总结
The aim of the research is to evaluate the effectiveness of virtual reality on the anxiety of patients with suspected endometriosis in gynecological consultation.
Indeed, several studies prove that patients in this situation are anxious. We would like to offer help in reducing anxiety in this case by means of digital therapy.
As part of this study, the equipment used will be "Bliss DTX". This is a non-drug digital therapy (digital therapeutics) already used in various hospital departments.
Bliss DTX immerses patients in sound and image programs scientifically developed for their effect on pain and anxiety, mobilizing their abilities and placing them in an altered state of consciousness. Bliss DTX software is delivered to patients via a dedicated video headset (virtual reality) and audio headset, as part of an integrated solution.
Conduct of the study:
The patient will be taken care of on the day of the consultation by a clinical research nurse. It will be installed in a reception room in the consultation room. The nurse will give him a questionnaire on anxiety to complete before the consultation.
A draw will be carried out with two options:
- Bliss DTX digital therapy via audio and video headphones lasting 13 minutes
- Installation in the reception room while waiting for the doctor to arrive. After the consultation, the patient will complete a new questionnaire on her state of anxiety and her feelings during the consultation.
A telephone call will be made 6 months after the consultation to collect post-consultation information.
Duration :
Duration of 6 months on 46 patients followed for 18 months. Expected benefits
- Reduction of anxiety after consultation by diversion of attention
- Strengthening the bond of trust between the patient and the care team
- Better monitoring and better compliance with treatment and medical examinations
- Better pain management
- Improved quality of life
Possible side effects:
No particular risks or constraints, however, a virtual reality headset can cause symptoms such as: nausea, dizziness, sweating, paleness, balance disorders grouped under the term "cybernetosis" as well as epileptic seizures in people. subjects predisposed to convulsions.
详细描述
Title :
ENDOREV: A solution to reduce anxiety during gynecological consultations in patients with suspected endometriosis?
Description of the study :
Single-center, randomized, controlled, open-label interventional study on two parallel groups Study composed of 46 patients randomized into two groups A and B with a ratio of 1:1 Experimental Group A: The patient will be installed in a reception room and will benefit from Bliss DTx digital therapy via a video headset and an audio headset for a duration of 13 minutes Group B control: The patient will be seated and wait for the doctor to arrive (no material) The duration of inclusion is 18 months and individual participation is 6 months, that is to say 24 months for the entire study.
Completion of the questionnaire (IASTA Y-1) for both groups before the consultation and data collection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Patient between 18 and 45 years old
- •Patient referred for suspected endometriosis
- •Patient consulting for the first time in the hospital
- •Patient with first-line or second-line imaging documenting endometriosis (ultrasound or MRI)
- •Patient agreeing to participate in the study and having signed informed consent
- •Patient affiliated to a social security scheme
- •Patient able to read and write French
排除标准
- •• Patient with a history of major pelvic surgery for endometriosis
- •Patient undergoing hysterectomy
- •Virgin patient
- •Pregnant woman
- •Patient with psychiatric pathology
- •Patient suffering from proven epilepsy
- •Patient under judicial protection
- •Patient under guardianship or curatorship
- •Patient with visual or hearing impairment
- •Patient with a progressive pathology responsible for chronic pain
结局指标
主要结局
Number of participants showing a reduction in post-consultation anxiety
时间窗: Pre-consultation until post-consultation
次要结局
未报告次要终点
研究者
Elise LUNELLI
research nurse
Poissy-Saint Germain Hospital