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临床试验/NCT04756375
NCT04756375已完成不适用

Evaluation of Virtual Reality to Save Morphinic in the Treatment of Vaso-occlusive Seizures of Sickle Cell Patients Consulting in the Emergency Room

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2021年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
97
试验地点
1
主要终点
Total dose of morphine

研究概览

简要总结

The management of pain in the emergency department is a major issue, especially for sickle cell patients who regularly consult for vaso-occlusive seizure (VOS). The place of virtual reality remains to be defined in a busy environment, in which the permanence of care generates a significant turn over of medical and paramedical personnel.

With Its immersive nature, allowing the patient to detach from his immediate environment, wich is often stressful for patients, we can hope that in multimodal management, Virtual Reality (VR) can contribute to a faster reduction in pain with lower doses of morphine, but so far we have no data.

Our pilot study aims to assess the effectiveness, feasibility and tolerance of adding virtual reality to the management of VOS in sickle cell patients in the ER.

详细描述

It will be a Before-after study: this study will be conducted in 2 phases in the emergency department

  • a period of usual management of sickle cell patients with VOS
  • then a phase during which the device will be used. Each phase will last 3 months; the duration of the periods may be shorter if recruitment targets are met. Patients will be included consecutively.

The main objective of the study is to measure the impact of virtual reality on the total dose of morphine administered to the emergency room in the treatment of vaso-occlusive seizures after initial morphine titration.

The primary endpoint is the total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by PCA (patient-controlled analgesia) and secondary titrations in the event of a recurrence of painful spikes with analog verbal scale (AVS) >7.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Supportive Care
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

  • •Age ≥ 18 years
  • •sickle cell patient consulting in the emergency room for VOS
  • •Signature free and informed consent

排除标准

  • •Consultation in the ER for the same reason in the 14 days prior to inclusion (same episode)
  • •Emergency room consultation more than 12 times in the previous year
  • •Nausea and vomiting at the time of inclusion
  • •History of epilepsy
  • •A visually impaired or hard of hearing patient
  • •Pregnant patient
  • •Previous inclusion in the study

研究组 & 干预措施

INTERVENTION

Experimental

Use of virtual reality in the management of sickle cell patients with VOS

干预措施: Virtual Reality (Device)

NO INTERVENTION

Other

干预措施: Usual Care (Other)

结局指标

主要结局

Total dose of morphine

时间窗: up to 48 hours

Total dose of morphine (in milligrams), used in the emergency room after initial titration, meaning the dose administered by PCA and secondary titrations in case of recurrence of painful peak with AVS\>7

次要结局

  • Feasibility of implementing the scheme(up to 48 hours)
  • Tolerance(up to 48 hours)
  • Acceptability(up to 48 hours)
  • Pain Efficiency(up to 48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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