Evaluation of the Effect on Pain of Attentional Diversion Associated with Hypnotic Induction by Virtual Reality (VRH) in Perioperative Prostate Biopsies Under Local Anesthesia: Prospective Randomized and Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- To prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset.
研究概览
简要总结
The primary objective of the study is to prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, either transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset. The study was sized based on a mean pain reduction of 1.5 points on a numerical scale (0-10 NAS), with an estimate of procedure-related pain of 4.0 on the NAS scale.
详细描述
Prospective comparison of pain during the procedure assessed in patients treated for prostate biopsies under local anesthesia with or without a virtual reality headset.No additional examination will be performed in addition to the conventional management of a biopsy except for the fitting of the headset for patients randomized to the "with virtual reality headset" group.
Patients will be randomized on the same day of the procedure into one of the two study groups.
A single follow-up visit will be performed postoperatively 1 month after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The maximum value of the pain will be collected by the research associate or the coordinating nurse who will be blinded to the randomization arm
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult patients who are candidates for ultrasound-guided prostate biopsies under local anesthesia, via transperineal or transrectal route
- •Patient having signed informed consent
排除标准
- •Patient suffering from blindness or any other visual handicap that contraindicates the use of the headset
- •Deaf or hard of hearing patients
- •Patients suffering from epilepsy and/or mental deficiency, and/or disorders of higher functions
- •Psychotic patients
- •Claustrophobic patients or those who cannot tolerate a mask over their eyes
- •Refusal of local anesthesia
- •Protected person (art. L1121-5 to L1121-8 of the CSP)
结局指标
主要结局
To prospectively compare perioperative pain assessed in patients undergoing targeted prostate biopsies, transrectally or transperineally, under local anesthesia with or without a virtual reality hypnosis headset.
时间窗: after the procedure
maximum pain felt during the procedure on a numerical EN scale, ranging from 0 (no pain) to 10 (extreme pain). The values will be collected directly at the end of the procedure.
次要结局
- Pain after the procedure(when leaving the hospital)
- Stress during the procedure(after the procedure)
- Immersion during hypnosis(at the procedure)
- Evaluation of the nociceptive response to painful stimuli(during the procedure)
- Satisfaction with the procedure(after the procedure)
- Duration of the procedure(after the procedure)
- Length of stay in hospital / outpatient care(at 1 month)
- Success of biopsies(at 1 month)
- Need for general anesthesia(after the procedure)
- Pain upon returning home the same evening and on D1(after procedure, at 1 day after procedure)
- Adverse effects related to the procedure during one month(at 1 month)
- Qualitative assessment of the patient's experience(after the procedure)
研究者
EssaiClinique_HYPNOSURG-VR
Professeur
University Hospital, Grenoble