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临床试验/NCT03924908
NCT03924908撤回不适用

Impact of Virtual Reality Hypnosis on Pain and Anxiety During Dressings Change in Burn Patients Treated as Outpatients

University of Liege0 个研究点开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
主要终点
Change in relaxation level

研究概览

简要总结

Different non-pharmacological techniques, including hypnosis and virtual reality are currently used as complementary tools in the treatment of pain related to burn injury. A new technique called 'virtual reality hypnosis' (VRH) (Patterson et al., 2004), which encompasses a combination of both tools, is regularly used although its actual function remains unknown to this date. With the goal to improve our understanding of VRH combination effects, it is necessary to elaborate randomized and controlled research studies in order to understand their actual function in individual's perception. 100 patients who are treated as outpatients for burn care will be randomly assigned to virtual reality or VRH. Patients will receive one session of one of these techniques during burn dressing change.Physiological parameters will be recorded during dressing change. Participants will fill in a questionnaire evaluating their tendency to be absorbed and dissociated, and another evaluating their level of perceived immersion. Their level of anxiety, pain, fatigue and relaxation will be evaluated before and after the session. A short interview will also be conducted to give participants the opportunity to openly describe their experience.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Burn patient treated as outpatient
  • •Burn surface area > or = 5% of the total body surface area
  • •mainly 2nd degree burn

排除标准

  • •Psychiatric antecedents
  • •Claustrophobia
  • •Heavy hearing
  • •Visual impairment
  • •Face burn
  • •Conjunctivitis
  • •Consent not obtained

研究组 & 干预措施

VRH

Experimental

Virtual reality hypnosis

干预措施: VRH (Behavioral)

VR

Active Comparator

Virtual reality

干预措施: VR (Behavioral)

结局指标

主要结局

Change in relaxation level

时间窗: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No relaxation = 0, maximum relaxation = 10.

Change in fatigue

时间窗: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No fatigue = 0, maximum fatigue = 10.

Change in anxiety: Visual Analogical Scale (VAS)

时间窗: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No anxiety = 0, maximum anxiety = 10.

Change in pain perception: Visual Analogical Scale (VAS)

时间窗: 5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1")

Visual Analogical Scale (VAS) from 0 to 10. This is a subjective linear scale. No pain = 0, maximum pain = 10.

次要结局

  • Time perception(5 minutes after dressing change ("time 1"))
  • Change in heart rate(5 minutes before dressing change ("time 0") and 5 minutes after dressing change ("time 1"))
  • Level of absorption at the moment(5 minutes after dressing change ("time 1"))
  • Level of dissociation at the moment(5 minutes after dressing change ("time 1"))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne-Françoise Rousseau

Head of Clinic, principal investigator

University of Liege

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