Randomized, Monocentric, Controlled, Superiority Phase II Trial Evaluating Clinical Hypnosis Using Virtural Reality vs Standard Pain Management Procedure During a Musculoskelettal Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Evaluate the benefit of the virtual reality in the pain management of patients needing a radio-guided musculoskeletal biopsy.
研究概览
简要总结
The primary objective of this trial is to evaluate the benefit of the virtual reality technology in the pain management for patients having a radio-guided musculoskeletal biopsy indication
详细描述
During the last years, the percutaneous biopsies took a growing importance in the diagnosis of musculoskeletal cancers. The most important advantages of percutaneous biopsies are: 1) Often performed under local anesthesia in out-patient department, 2) No visible scars, 3) Surgical intervention avoided in case of benign tumor with a low level of complications (infection, hematoma, pain).
The technology improvement of percutaneous biopsy leads to a high diagnosis success rate (80.8% for bone tumors and 83.2% for soft tissues tumors') with a low complication rate (0.7%) and then justifies the use of percutaneous biopsy as first-line diagnostic exam.
During a percutaneous biopsy, the pain is frequently felt with an increase in the "pain numeric scale" evaluated after the procedure.
The nitrous oxide is a gas mixture which can be used for its anesthetic and antalgic properties, making the pain tolerable for the patients during short procedures. However, it can cause adverse events such as nausea, vomiting and nervous system affections (excessive sedation, anxiety). Moreover, this gas is not always efficient for the pain management.
Other options have been investigated such as hypnosis and music therapy which improve patients' experience of the medical interventional procedures.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman, aged >= 18 years at the day of consenting to the study (no upper limit)
- •Requiring a radio-guided biopsy of the musculoskeletal system,
- •Informed and signed consent,
- •Patient covered by a medical insurance.
排除标准
- •Deaf patient;
- •Visually-impaired patient;
- •Claustrophobic and/or aquaphobic patient;
- •Contraindication to a musculoskeletal biopsy, including to the premedication protocol and to the lidocaine;
- •Person deprived of liberty or placed under guardianship;
- •Absence of French language skills;
- •History of psychiatric disease such as paranoia, schizophrenia, manic-depressive psychosis, patient with a high risk of suicide.
研究组 & 干预措施
Deep local anesthesia alone
The musculoskeletal biopsy is performed according to the standard practice using a deep local anesthesia with premedication and lidocaïne.
干预措施: Deep local anesthesia alone (Procedure)
Deep local anesthesia + Virtual reality
Pre-medication procedures and lidocaïne injection are the same as in the current practice. During the intervention delay, the patient will also experience hypnosis through a virtual reality procedure .
干预措施: Deep local anesthesia + Virtual reality (Procedure)
结局指标
主要结局
Evaluate the benefit of the virtual reality in the pain management of patients needing a radio-guided musculoskeletal biopsy.
时间窗: Day 0
The main outcome will be the pain level auto-evaluated by the patient using a numeric scale composed of 11 graduations (from 0 to 10)
次要结局
- Evaluate the global satisfaction of patients in both arms(Day 0)
- Evaluate the analgesics consumption in both arms(through study completion, an average of 24 hours)
- Evaluate in both arms, the pain linked to the biopsy procedure using a numeric scale graduated from 0 to 10.(Day 1 (+/-2h) post biopsy)
- Evaluate in both arms, the anxiety linked to the biopsy procedure using a numeric scale graduated from 0 to 10(Day 0)
- Evaluate costs in both arms(through study completion, an average of 24 hours)