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临床试验/NCT00163917
NCT00163917Unknown不适用

Predicting the Effectiveness of Virtual Reality Relaxation on Pain and Anxiety When Added to PCA Morphine in a Population of Burn Patients Having Dressing Changes

Bayside Health2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2004年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
2
主要终点
Association between hypnotic susceptibility and pain scores

研究概览

简要总结

The purpose of this study is to evaluate whether a sub-population of patients with burn injuries needing dressing changes respond to virtual reality (VR) utilising relaxation themes with improved pain and anxiety scores, when added to PCA morphine and background analgesic therapy.

详细描述

Pain associated with burn dressing changes does not arise purely from a physical source; it is also commonly influenced by psychological factors. The anticipation that accompanies a dressing change has the potential to set up fear and heightened anxiety as the patient is aware that at a predetermined time other people will manipulate injured areas on his/her body.

Many techniques of analgesia have been advocated in burn dressing changes. Opiates have been the mainstay, and many techniques for their administration have been described. In particular the use of background plus PCA administration of opiates has been demonstrated to be superior to PCA administration alone. Another analgesic/dissociative agent commonly described for these procedures is Ketamine. Both opiates and ketamine have limitations in that they cause unfavourable side effects such as respiratory depression, sedation and nausea and vomiting in the case of opiates and respiratory depression, hallucinations and unpleasant dreams in the case of ketamine. Other problems relating to the use of opiates and ketamine relate to the approach of treating a multifaceted experience such as burn dressing pain solely with pharmacotherapy.

The need for psychological interventions in burn dressings has been highlighted by many researchers. In particular, Ptacek noted that burn patients experiencing more anxiety tended to have higher ratings of pain, while those with larger areas of burns reported more affective pain and greater variability in pain ratings.

There is strong consistency among reviewers for recommending the addition of adjunctive therapies of a psychological nature for managing patients having burn dressing changes. Patterson et.al in particular is of the belief that burn patients having dressing changes are more amenable to hypnotherapy as an analgesic adjunct.

The nature of psychological interventions examined by researchers have included hypnosis (where strong suggestions were aimed at reducing tension, anxiety, and sensation of pain), rapid induction analgesia, simple stress reducing strategies, attention and information, and autohypnosis. While some have conducted prospective trials which involve large numbers of patients, only one trial actually made mention of randomizing participants. Most other reports examining psychological therapies have been at the case report level.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Burn injury
  • Scheduled for painful dressing changes
  • Conscious
  • Comprehension of PCA and virtual reality device
  • Comprehension of the English language

排除标准

  • Patient refusal
  • Psychotic disease
  • Paranoid disease
  • Unstable dissociative disorder
  • Borderline personality disorder
  • Phobias relevant to water/drowning
  • Epilepsy/propensity to fitting
  • Morphine allergy
  • Acute brain syndrome
  • Chronic brain syndrome
  • Physically unable to administer PCA
  • Severe burns involving the head
  • Visual impairment

结局指标

主要结局

Association between hypnotic susceptibility and pain scores

Association between hypnotic susceptibility and anxiety scores

次要结局

  • Measurement of pain by visual analogue scale (VAS)
  • Measurement of anxiety by Burns Specific Anxiety Rating by VAS
  • Rating of hypnotic susceptibility and morphine use
  • Satisfaction rating
  • Morphine use
  • Incidence of side effects relating to morphine and VR

研究者

发起方
Bayside Health
申办方类型
Other Gov

研究点 (2)

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