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临床试验/NCT04024904
NCT04024904已完成不适用

Virtual Reality Hypnosis Distraction Utility to Improve the Quality of Routine Procedure-related Pain During Preoperative Locoregional Anaesthesia

Erasme University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年7月26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
60
试验地点
2
主要终点
Proportion of patients receiving pharmacological sedation

研究概览

简要总结

Regional anaesthesia has many advantages but it might be a stressful and painful experience. Usually, the anesthetist administers a pharmacologic intravenous sedation to achieve patient's comfort. Though, these medications are not benign, and disadvantages include unpredictable response, adverse effects, and interference with cooperation. The virtual reality hypnosis distraction (VRHD) could be a good non-pharmacological technique to improve patient's comfort, decrease anxiety and procedure related pain. This study is a prospective study where sixty patients scheduled for orthopedic surgery requiring regional anesthesia were randomized in three groups according to the use or not of VRHD during the regional procedure or before as a complementary premedication. The anesthetic management during the regional procedure and the surgery remained otherwise standard for each patient. The first endpoint is the proportion of patients receiving pharmacological sedation (in the VRHD groups compared to the pharmacological sedation group). .

The second endpoint is to determine if the VRHD increases the patient's satisfaction of their anaesthetic management.

The third endpoint is to study various parameters of use of this specific anaesthetic management: time required for the installation and operation time of the VRHD device; the variation of haemodynamic parameters between the separate groups; pain procedure-related and behavioural pain scale scores between the separate groups.

详细描述

Background Regional anesthesia has many advantages but it might be a stressful and painful experience and the anaesthetist has to establish all the necessary measures to maintain patient's comfort and cooperation. In practice, this ideal situation may be the most challenging part of the regional anesthetic practice. Usually, the anesthetist administers a pharmacologic intravenous sedation, including opioids and benzodiazepines to achieve patient's comfort. These medications are not benign, and disadvantages include possible unpredictable response, adverse effects, and hindered cooperation.

Among the non-pharmacologic techniques which may be used to improve the patient's comfort, decrease anxiety and procedure related pain, hypnosis and virtual reality distraction are increasingly used.

In spite of the encouraging scientific and clinical findings, hypnosis for analgesia is not universally used in medical centers. Its widespread use has been limited by factors such as the advanced expertise, time and effort required by clinicians to provide hypnosis, and the commitment required by patients to engage in hypnosis. It is a challenge to make hypnosis a standard part of care in this environment.

Improvements in technologies made virtual reality (VR) distraction a unique practical tool to provide an immersive, multisensory and three-dimensional (3D) environment that creates a sense of presence which enables to modify the perception of reality and to capture a greater degree of attention. Several theories have been proposed to explain how distraction may inhibit or decrease perception of pain by capturing a greater degree of attention. The "virtual reality analgesia" (= analgesia produces by virtual reality) is a product of the attentional distraction. Hoffmann et al. explained that there is a limit to the conscious attentional resources humans have available to process large amounts of incoming information. Conscious attention is required for pain perception. Hoffmann et al. theorize that the more immersive the VR system, the more attention will be drawn into the virtual world, leaving less attention available to process nociceptive signals.

Until now, VR shows an interest in numerous clinical applications (to help treat anxiety disorders, control pain, support physical rehabilitation, and distract patients during wound care) VR technology guides the patient through the same steps used when hypnosis is induced through an interpersonal process. With attentional mechanisms as a common denominator, the attention-captivating qualities of virtual reality and the suggestion inherent in hypnosis, the potential for a synergistic effect between these modalities is significant.

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
Single (Outcomes Assessor)

盲法说明

Patients were coached by a separate practitioner aside from the regional anaesthesiologist performing the regional block. The anesthetists in charge of the patient were not blinded, but data collection and statistical analysis were blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergoing elective orthopedic surgery with regional anaesthesia (peripheral nerve block), were aged ≥ 18 years

排除标准

  • ASA (American Society of anesthesiologists) IV, spinal anesthesia, claustrophobia, blindness, deafness, unable to complete a satisfaction survey, previously documented history of neurologic disease, lack of written informed consent, urgent surgery, allergy to a drug used within the study, ongoing pregnancy, patient's infectious isolation

结局指标

主要结局

Proportion of patients receiving pharmacological sedation

时间窗: immediately after the regional procedure

Collecting the proportion of patients (n) receiving pharmacological sedation as opioids (micrograms) and benzodiazepine (milligrams) from the beginning to the end of the regional procedure.

次要结局

  • patient's satisfaction with visual analogue scale(VAS) (a range of scores from 0-10)(immediately after regional procedure)

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Van Hecke Delphine

Principal Investigator, attending physician

Erasme University Hospital

研究点 (2)

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