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临床试验/NCT02456987
NCT02456987已完成不适用

The Feasibility, Usability, Acceptability, and Clinical Utility of a Virtual Reality Intervention in the Inpatient Setting

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年6月30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
100
试验地点
2
主要终点
Qualitative Survey Instrument

研究概览

简要总结

This study is being conducted as a pilot to test the feasibility, usability, acceptability, and clinical utility of using a virtual reality (VR) immersion experience in the inpatient setting. In addition to determining whether the patients enjoy the experience and would like to participate in a future more tailored immersion in virtual reality, we will be attempting to determine whether there are any positive impacts on their visit, including a distraction from their pain or anxiety associated with their procedures or the reason they have been admitted to the hospital.

Because the inpatient population at Cedars-Sinai Medical Center (CSMC) is dynamic and diagnostically diverse, we intend to develop a series of VR interventions that broadly address patient concerns. VR has only been tested in select patient populations, so we are equally interested in the feasibility of deploying VR across the inpatient hospital environment as we are in demonstrating some effectiveness in reducing pain and anxiety, and improving satisfaction.

The present study has the following aims:

  1. Adapting existing VR environments for inpatients with a variety of impairments, utilizing cost-effective VR hardware (Phase 1).
  2. Assess the usability and acceptability of the VR equipment and software by hospital inpatients by conducting qualitative interviews (Phase 2).
  3. Assess the clinical utility of the VR intervention by measuring patient reported outcomes using a modified care satisfaction survey, administered to inpatients receiving VR and a matched control sample (Phase 3).

Concerning Aims 2 and 3, we hypothesize the following:

  1. Inpatients will find the VR intervention helpful and enjoyable, and will believe that its benefits outweigh any difficulties encountered using the hardware or software.
  2. Inpatients who are exposed to the VR intervention will report significantly improved pain management, greater satisfaction with their inpatient visit, and greater overall health compared to matched control inpatients that were not exposed to VR.

详细描述

Recent advances in Virtual Reality (VR) technology have made it possible for researchers to develop interventions for a wide variety of disease states, including obesity, pain, impaired motor functioning, and anxiety. Over the last decade, improvements in software and hardware design, as well as associated cost reductions, have made VR a practical tool for widespread use, rather than an expensive novelty. Interventions that would not be possible or practical in the real world have been developed in the virtual world, resulting in immersive multi-sensory (primarily audio-visual) experiences that can distract patients from painful experiences and motivate them to achieve personal goals.

VR environments allow patients to visualize non-disease states, and practice living more healthily, whether the focus is stroke rehabilitation, exposure therapy for social anxiety, or simply interacting with the world with reduced pain levels. A number of studies have demonstrated the efficacy of VR interventions, and all of them are built around this basic premise. For example, a meta-analysis of diagnosis-specific exposure therapies for anxiety disorders - PTSD, agoraphobia/panic disorder, social anxiety, and animal phobias) reports large effects (Cohen's Q-statistic >0.80) for VR interventions on symptom reports at therapy termination.1 Similarly, a meta-analysis of post-stroke motor rehabilitation VR interventions reports that, in observational studies, patients experience significantly reduced impairment (14.7%) and improved motor functioning (20.1%).

Hospital inpatients will most likely benefit from VR as a distraction from acute pain during procedures, painful drug infusions, adverse side effects of treatments, or from boredom and inactivity, which could lead to increased reports of distress and reduced satisfaction with care. Several areas of research may provide a useful model for bringing VR distraction interventions to all types of hospital inpatients. A recent review by Li and colleagues (2012) highlighted advances in these treatment areas.

To date, the most widely studied form of VR interventions is the reduction of pain and anxiety associated with burn care. Compared to use of analgesic medication alone, patients who use VR distraction interventions in combination with analgesic drugs have reported reduced pain and distress during burn wound care across most studies, and both lower pain ratings and increased range of motion during physical therapy in some studies. Use of a VR distraction environment called SnowWorld - developed by H.G. Hoffman and colleagues, and employed across many of these studies - allows burn patients to move through ice canyon and play with snow. Additions of VR hypnosis and relaxation modules to SnowWorld have also been tested in burn patients, with mixed results; patients undergoing hypnosis reported lower pain and anxiety levels, but those undergoing relaxation while receiving morphine reported higher pain levels.

Studies of cancer patients have demonstrated some efficacy for use of VR in patients receiving chemotherapy and lumbar punctures. Although pain scores are often reduced in a direction favoring the use of VR, studies to date have not demonstrated conclusive, long term benefits for symptom reduction. However, patients do report short perceived time in treatment, reduced physiological arousal during treatment, and lower perceived pain during treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Able to understand the goals of the study and provide informed consent
  • Any Inpatient at CSMC ISP, admitted between June 2015 and 31 December 2016, who is not excluded due to criteria listed below.
  • At least 18 years of age
  • English speaking

排除标准

  • Unable to consent to study due to cognitive difficulty
  • Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software
  • Vision requiring correction with eyeglasses (except nearsightedness, which can be accommodated by the Gear VR goggles)
  • Sensitivity to flashing light or motion*
  • Recent stroke
  • Transplant patient
  • Patient on ventilator, BiPAP, or other breathing assistance equipment
  • Recent injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software*
  • Non-English speaking

研究组 & 干预措施

Intervention

Experimental

Patients that qualify for the intervention will receive the Samsung Gear virtual reality experiences and will participate in a brief survey about their opinions and preferences once the experiences are completed.

干预措施: Samsung Gear (Device)

Control

No Intervention

Age and sex matched control participants will be asked to answer a series of satisfaction questions after the study recruitment period is over. These individuals will have been inpatients during the same time as the intervention participants.

结局指标

主要结局

Qualitative Survey Instrument

时间窗: up to 10 min (Immediately following intervention)

Patients involved in the intervention will be asked a series of qualitative questions asking about their overall experience of the virtual reality intervention as well as the different virtual experiences and how they might change them.

次要结局

未报告次要终点

研究者

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

Brennan Spiegel

Director, Health Services Research

Cedars-Sinai Medical Center

研究点 (2)

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