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临床试验/NCT03665233
NCT03665233终止不适用

Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty: a Randomized, Controlled, Multi-center, Double Blind, Parallel Group, Superiority Trail to Evaluate VR as a Component of a Multi-modal Pain Treatment

Clinique Saint-Jean, Bruxelles2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
40
试验地点
2
主要终点
The comparison of opioid consumption after physiotherapy, when using VRH or VR sham

研究概览

简要总结

Virtual reality has been used for acute pain management (burn patients) with positive results. Hypnosis has known beneficial effects on patients in the peri-operative setting. The investigators are combining both by giving a virtual reality hypnosis (VRH) session to the patients during a known painful post-operative moment. (physiotherapy) It is the investigator intention to compare pain after physiotherapy during the first 3 days after a total knee arthroplasty, between 2 groups. One group , the VR group gets standard treatment with VRH and the second, the sham group, gets standard treatment with a sham VR session.

详细描述

Introduction: Postoperative pain frequently occurs after total knee arthroplasty. The IASP defines pain as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage". Pain is a major cause of post-operative distress and has a variety of side effects and complications. Chronic post surgical pain is probably the most feared complication of acute pain. Therefore, adequate pain control after surgery is mandatory.

In modern western healthcare, multi-modal pain treatment is the standard of care. This means that a variety of drugs, acting on different receptors, are used alongside non-pharmacological interventions, to decrease pain. Such an approach enables the physician to use a lower concentration of a specific drug, in order to avoid adverse effects that can occur when giving higher doses of one individual drug. These drugs are based on the analgesic ladder of the WHO to relief cancer pain. From the different drugs that are used, the major concern will be with the opioids, as they are known to have major complications. Especially today in the USA there is an epidemic of opioid related deaths. Very often these drugs have been prescribed in a post-operative setting. The search for a different non-pharmacological analgesic treatment is today, more than ever, a pressing need.

Virtual reality (VR) is a non-pharmacological way to decrease pain in a number of different situations. It has been around for some years, some articles describing VR in medicine are 25 years old but it only recently became a popular medical treatment since the introduction of the Oculus Rift in 2014. Before that HMDs (head-mounted display) were expensive and very bulky devices. Since the introduction of the Oculus Rift HMD the availability and usability of VR has increased dramatically.

In the post-operative period pain at rest is generally reported to be acceptable by our patients (VAS<3), but if movements are involved the pain increases to unacceptable levels. Postoperative physiotherapy generally involves the use of a continuous passive motion (CPM), a machine used for passive bending of the knee. This postoperative mobilization is one of the major causes of pain in the aftermath of a total knee arthroplasty.

Available evidence: Virtual Reality (VR) has been shown to reduce pain in different situations. From experimental pain in healthy subjects to changing dressing of burn patients, several studies have shown the use of immersive VR therapy as an adjunct for pain treatment.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having a TKA
  • General anesthesia and single shot fem block
  • Adults (> 18 years)
  • Elective procedures

排除标准

  • Refusal of consent
  • History of seizures
  • History of drug abuse
  • History of psychiatric diseases
  • Patients with impaired hearing
  • Patients with impaired vision
  • Patients afraid of submarine worlds
  • Chronic pain patients
  • Claustrophobia
  • Language not available on VR system

结局指标

主要结局

The comparison of opioid consumption after physiotherapy, when using VRH or VR sham

时间窗: on post operative day 3

After each physiotherapy session with continuous passive movement (CPM), a blinded investigator will measure the opioid consumption

次要结局

  • The variation in patient satisfaction at the end of the third day, between the participants using the VRH or not.(on post operative day (POD) 3)
  • The comparison of the evolution of the knee flexion with the CPM (Continuous passive motion) when using VRH or not(on post operative day 1 and 3)
  • The variance in the length of stay after a total knee arthroplasty between the treatment and the control group.(This will be assessed 1 week after surgery)
  • The change in anxiety measured with an anxiety scale, after physiotherapy, between the control (standard treatment ) and the VR group (standard + VR treatment)(on post operative day (POD) 1-2-3)
  • The comparison in pain after post-operative physiotherapy using VAS(on post operative day 1-2-3)

研究者

发起方
Clinique Saint-Jean, Bruxelles
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Arnaud Bosteels

Head of the anaesthesia department, principal investigator

Clinique Saint-Jean, Bruxelles

研究点 (2)

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