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临床试验/NCT05545033
NCT05545033已完成不适用

Evaluating the Feasibility and Acceptability of the Use of Virtual Reality in Pain Management in Hospitalized Patients

Changi General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Patient acceptability and tolerability

研究概览

简要总结

Acute and chronic non-cancer pain is a common healthcare problem locally and globally, leading to many inpatient admissions for poorly controlled pain. The World Health Organisation has declared that access to adequate pain control is a fundamental human right. Yet in our current practice, both acute and chronic non-cancer pain remain poorly controlled.

There is passive over-reliance on pharmacological agents and interventional procedures in the management of pain. The opioid epidemic with issues of dependence, misuse, and overdose is especially concerning. Therefore, there is a pertinent clinical need to find sustainable non-pharmacological adjuncts in the complex management of pain.

Virtual reality (VR) involves the use of technology to create a three-dimensional multisensory artificial environment replacing real-world sensory inputs. Initially created solely for entertainment purposes, VR applications have since expanded and made its way into healthcare. In Pain Medicine, the application of VR has been promising. There is currently no VR study done in our local population who suffer from pain issues. In our study, we aim to test the feasibility of applying the use of VR in patients admitted inpatient due to pain issues. We believe that VR can be used as an adjunctive tool improve pain management and patient satisfaction.

详细描述

Patients who agree to participate in the study will undergo the following procedures:

  1. Provide written informed consent,
  2. Provide baseline demographic information,
  3. Provide baseline pain and anxiety ratings,
  4. Undergo 5 to 15 minutes VR exposure,
  5. Take 3 to 5 minutes break,
  6. Undergo 5 to 15 minutes VR exposure,
  7. Provide post-intervention pain and anxiety ratings,
  8. Complete validated questionnaires.

The Oculus Go Head-Mounted Devices (HMD) will be put in place on the patients as follows:

  1. Patient places sanitary hairnet on head,
  2. Patient places disposable face liners secured by rubber bands over their ears,
  3. Study coordinator places pre-sanitized Oculus Go HMD over patient's disposable face mask and adjusts straps for comfort.

Trial Product:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
21 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalised patients with complain of pain issues (at least one of the following),
  • Acute pain
  • Acute exacerbations of chronic pain
  • Chronic non-cancer pain
  • Post-procedural pain (limited to those who undergo procedures with < 2 hours in duration)
  • Age equal or more than ≥ 21 years,
  • No visual or hearing impairment,
  • English literacy.

排除标准

  • Cancer-related pain,
  • Comorbidities affecting usage of VR e.g. motion sickness, stroke, seizure, dementia, transmissible diseases, severe facial eczema,
  • Undergoing litigation.

结局指标

主要结局

Patient acceptability and tolerability

时间窗: post-intervention (up to 1 hr)

Validated questionnaires - patient experience satisfaction (0 to 10; 0-worst outcome, 10-best outcome), System Usability Scale (\<50-not acceptable, 50-70-marginal, \>70-acceptable)

次要结局

  • Clinical efficacy of virtual reality(pre- and post-intervention (up to 1hr))

研究者

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

Lydia Li Weiling

Consultant, Department of Anaesthesia and Surgical Intensive Care

Changi General Hospital

研究点 (2)

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