Virtual Reality Therapy for Pain Management at the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- NRS-Pain score at rest
研究概览
简要总结
Rationale: Prescriptions of analgesics, especially opioids, have doubled in the Emergency department (ED) over the past decades in response to frequently reported undertreatment of pain in ED patients. Consequently, there is a shift towards a more restrained utilisation of opioids at the ED. However, there are still few (non-)pharmacological alternatives.
Virtual Reality (VR) therapy is a relatively new and promising technique in non-pharmacologic pain reduction and anxiolysis and shows positive results on pain relief and pain.
Objective: Primary objective is to investigate the effect of VR on patient-reported pain outcomes in the ED. Secondary objectives are to investigate the effect of VR on analgesics use, patient-reported outcomes, and process indicators and to identify barriers to implementation. Last, subanalyses will be performed to compare the effectiveness of two types of VR: VR based on distraction (VRD) and VR based on focussed attention (VRF).
Study design: randomized controlled trial.
Study population: Adults admitted to the ED with a NRS pain score of 4 (out of ten) or more and unacceptable pain.
Intervention: There will be a control group receiving usual care and a intervention group that receives additional VR therapy.
Main study parameters/endpoints: The main study outcome is the difference in patient-reported NRS pain score.
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
- None
入排标准
- 年龄范围
- 16 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥16 years admitted to ED
- •NRS pain at rest score ≥4
- •Pain not acceptable for patient
- •Patient is willing and able to comply with the study protoc
排除标准
- •Patients initially treated by another physician than the emergency physician (EP).
- •EMV < 14
- •History of dementia, seizures
- •Severe hearing/visual impairment not corrected
- •Headwounds or damaged skin with which comfortable and hygienic use is not possible.
- •Presentation to the ED because of chronic pain (≥3 months) exacerbation
- •Chronic opioid use (≥3 months)
- •Psychiatric disorders interfering with patients' understanding of the study protocol and informed consent
结局指标
主要结局
NRS-Pain score at rest
时间窗: throughout study participation, up to 8 hours
Pain score before and after administration of VR
次要结局
- Administered non-pharmacological analgesia (e.g. casting, reduction of fracture)(throughout study participation, up to 8 hours)
- Satisfaction with pain management(Assessed at moment of discharge, up to 6 hours after inclusion)
- Acceptability of pain at discharge (yes/no)(Assessed at moment of discharge, up to 6 hours after inclusion)
- NRS anxiety scores(Measured every 30 minutes until discharge of patient to maximal 6 hours)
- Oral Morphine Equivalent (OME)(throughout study participation, up to 8 hours)
- Analgesics prescription by emergency physician(throughout study participation, up to 8 hours)
- Side effect during VR therapy(evaluated every 30 minutes up to max 6 hours)
- Patients desire for analgesics upon admittance and at discharge (yes/no)(Asked at moment of admittance and at discharge, up to 6 hours after inclusion)
- Duration ED visit(throughout study participation, up to 8 hours)
- Interview one week after ED admission about patient experiences(approximately one week after ED admission)
- Administered analgesics at the ED and type(throughout study participation, up to 8 hours)
- NRS immersion score(Assessed at moment of discharge, up to 6 hours after inclusion)
- follow-up of patient(Assessed at moment of discharge, up to 6 hours after inclusion)