NCT04478253已完成不适用
Effect of the Use of HYPNO VR on Pain Experienced During Chest Drain Insertion in Resuscitation Vigilant Patients.
GCS Ramsay Santé pour l'Enseignement et la Recherche2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年5月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Pain intensity progression
研究概览
简要总结
The main objective of this study is to evaluate, in vigilant resuscitation patients, the effect of the use of HYPNO VR on the pain felt during the insertion of a thoracic drain.
详细描述
This is a prospective, randomized, open-label, monocentric, prospective study of two parallel groups of patients in whom a chest tube is to be inserted:
- Group 1: Insertion of the drain according to the usual management protocol.
- Group 2: Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
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 18 years of age or older, having read and signed the consent form for participation in the study
- •Patient admitted to intensive care whose state of health requires the insertion of a thoracic drain according to the doctor in charge of the patient.
排除标准
- •Patient under legal protection, guardianship or trusteeship
- •Pregnant or breastfeeding patient
- •Patient not affiliated to the French social security system
- •Hearing or visual disturbances contraindicating the use of virtual reality headphones
- •Inability to provide the subject with informed information and/or written informed consent: dementia, psychosis, consciousness disorders, non-French speaking patient
- •Unbalanced epilepsy
- •Contraindication to local anaesthesia, one of the analgesics or sleeping pills used in the protocol
- •Need for drainage in a life-threatening emergency (respiratory distress or compressive pleural effusion)
- •Concurrent participation in other research or during a period of exclusion from previous research
结局指标
主要结局
Pain intensity progression
时间窗: 24 hours
The intensity of pain associated with chest drain insertion (difference between pain felt at the time of insertion and basal pain prior to the procedure) is the primary endpoint. This will be measured on a simple numerical scale Graduated from 0 (no pain) to 10 (worst pain imaginable). Basal pain will be assessed 15 min before drainage, then immediately after insertion and after 4h, 8h, 12h, 16h, 20h and 24h.
次要结局
- Evaluation of sleep quality simple numerical scale graduated from 0 (very bad) to 10 (very good) on the first night after insertion of the drain and evolution compared to usual sleep quality.(24 hours)
- Evolution of pain measured on a simple numerical scale over 24 hours(24 hours)
- Pain distress measured on a simple numerical scale during the procedure and evolution from basal state(24 hours)
- Anxiety level measured on a simple numerical scale and the State-trait Anxiety Inventory scale (STAI-Y scale) during the procedure and evolution from basal status(24 hours)
- Drug consumption during the 24 hours following the insertion of the drain: analgesics (paracetamol, Tramadol, Nefopam, Morphine), Bromazepam and Zopiclone.(24 hours)
研究者
研究点 (2)
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