Surgery and Virtual Reality: Interest of Virtual Reality in Oncology for Procedures Under Local Anesthesia in the Operating Room
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 3
- 主要终点
- Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the maximum subjective pain induced by the surgical procedure
研究概览
简要总结
Virtual Reality (VR) is an interactive and immersive technology that allows you to evolve in a three-dimensional environment created by computer. It appeals to the senses of people by reproducing universes close to reality or imaginary. This process is currently the subject of numerous studies in the field of health because it is a non-invasive tool, a non-pharmacological alternative for the management of pain, anxiety and patient satisfaction.
People with cancer can have a complex care pathway with psychological, anxiety-provoking and potentially painful repercussions. It is for these reasons that offering VR in the operating room for certain procedures under local anesthesia would improve the experience and comfort of care.
BOREV study will assess the interest of VR on pain for procedures under local anesthesia in the operating room in the context of cancer care. The software used, called HypnoVR©, is a medical device, developed specifically for the management of anxiety and pain through hypnosis, sophrology and relaxation techniques.
The main objective of this study is to compare the maximum pain felt with and without RV for different oncological surgical procedures performed under local anesthesia including anesthetic procedures and surgical procedures. The secondary objectives that will support this research are: the evaluation of the level of anxiety, the link with the pain component via the Analgesia Nociception Index (ANI), as well as the satisfaction of the patient and the operator.
According to the results obtained, the VR device could lead to a change in practice in the management of patients and thus be offered on a larger scale within the framework of the management of pain and anxiety
详细描述
Description of the modalities for recruiting :
During the preoperative consultation, the surgeon or anesthesiologist presents the study to the patient with a cancer requiring a surgery under local anesthesia. He gives the patient the consent form to participate in the study.
Once the consent form has been signed by the patient and the investigator, the investigator prescribes a screening test before surgery.
Patients registration and randomization :
Any patient who has signed an informed consent form (ICF) must be registered in the eCRF in order to be assigned a patient number.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 or more
- •Patient eligible for surgery under local anaesthesia in the operating room
- •Written informed consent obtained from the patient
- •Patient has valid health insurance
排除标准
- •Surgical procedure requiring complementary anaesthetic products such as intravenous sedation, nitrous oxide
- •Patient requiring an epidural, a paravertebral block
- •Patient with known allergy(ies) to local anaesthetics
- •Patient with schizophrenia, seizure disorder
- •For the investigation site with PhysioDoloris monitor (MDMS): Patient with contraindications to ANI monitoring:
- •Known heart rhythm disorder (complete arrhythmia by atrial fibrillation) Pacemaker Apnea
- •Administration of a sedative premedication in the 6 hours before the surgery
- •Visually or hearing impaired patient without a hearing aid
- •Patient deprived of liberty or under guardianship
结局指标
主要结局
Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the maximum subjective pain induced by the surgical procedure
时间窗: Immediately after surgery
Maximum subjective pain is measured by a numerical pain scale of 0 to 10. (0 : no pain ; 10 : maximum pain)
次要结局
- Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of hemodynamic constants(in preoperative ; during the surgical procedure ; immediate postoperative)
- Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of anxiety(in preoperative ; immediate postoperative ; within 30 minutes after the surgery)
- Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of operator of the surgical procedure(immediate postoperative)
- Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of patient satisfaction(immediate postoperative)
- Comparison, between the "local anesthesia + virtual reality" group and the "local anesthesia alone" group, of the objective pain induced by the surgical procedure in patients with Analgesia Nociception Index(in preoperative ; during the surgical procedure ; immediate postoperative)