Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Change in Visual Analog Scale (VAS)
研究概览
简要总结
This study seeks to explore the efficacy of immersive multimedia experiences as a practical adjunctive therapeutic intervention in the self-management of the chronic pain associated with cancer patients. A comparative controlled interventional trial and qualitative interpretative-descriptive exploration will be undertaken with 100 cancer patients who are experiencing chronic pain. Participants will be randomly assigned to either a virtual reality (VR) therapy group or a 2D computer based multimedia control group (50 subjects in each).
They will undertake either a series of VR interventions, or 2D computer based multimedia control sessions in their own homes over a period of a month. The intervention will be used daily for a month to enable customization to the therapy and record data over a long enough period of time to account for any individual short-term changes in pain.
The VR sessions will consist of using a VR head mounted display (HMD) and computer to explore interactive immersive environments. The control group will be exposed to similar 2D computer based multimedia experiences (without a VR headset) that on home computers. Pre, during, and post pain test scores and quality of sleep assessments will be recorded using standardized tools.
In addition to the primary study, a sub-study will be conducted where ten of the subjects who demonstrated the most improvement in their pain using the VR experience will be selected and invited to explore for any measurable changes in neurological activity using pre and post exposure electroencephalography (EEG).
详细描述
This study seeks to explore the efficacy of an immersive multimedia experience as a practical therapeutic intervention in the self-management of the chronic pain associated with cancer patients.
This work will inform further clinical studies and future research into the potential uses of immersive multimedia in the treatment of cancer associated pain. Furthermore, it will help identify optimal immersive multimedia environments for use in chronic pain applications, practical determinants for implementation of immersive multimedia for wider practice, and will provide a better theoretical understanding of the mechanisms whereby immersive multimedia works in chronic pain.
JUSTIFICATION
Cancer survivorship refers to individuals who have remained cancer free for a minimum of 5 years. Due to developments and greater outcomes associated with cancer therapy and management, the number of individuals who survive cancer has risen considerably over the past decade. Currently, 65% of adults and 80% of children can be expected to live at least 5 years post cancer diagnosis. However, for some, survivorship is associated with debilitating chronic pain which impacts negatively on quality of life. Reviews have suggested that up to 40% of individuals have survived cancer remain with cancer related chronic pain.
With rapidly emerging immersive multimedia technologies and clinical work in this field, it would appear that immersive multimedia may have significant potential for use as an adjunctive therapeutic measure for pain control. However, there has been little work done to establish the potential use of immersive multimedia in the management of chronic cancer pain to date, as most work on immersive multimedia for pain management has focused on acute pain via distraction. Several researchers have recommended the investigation of immersive multimedia for chronic, long term pain, and the research team completed a pilot study in 2015 to establish best methods and approaches for using immersive multimedia in chronic pain conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 16 or older
- •Previous or current medical diagnosis of cancer
- •Previous or current treatment by chemotherapy, radiotherapy, hormonal
- •Currently an outpatient (not hospitalized)
- •Chronic pain sufferer (suffering ongoing daily pain for 3 months or more with a Neuropathic Rating Pain Scale score of 4 or more)
- •Able to understand the English language, and read and write English
- •Have normal stereoscopic (binocular) vision
- •Able to easily move your head up, down, left and right and wear a headset
- •Have fine motor control in one hand sufficient to operate a joystick/control
- •Have space at home for a computer and monitor equipment
排除标准
- •Cognitive impairment/inability to control a basic computer VR interface, or complete questionnaires
- •Receiving regular non-pharmacological pain relieving adjunct therapies for the management of chronic pain
- •Susceptibility to motion sickness/cyber-sickness
- •Susceptibility to claustrophobia (fear of confined places)
- •History of susceptibility to seizures
结局指标
主要结局
Change in Visual Analog Scale (VAS)
时间窗: Right before intervention (Pre), during intervention (During) and right after intervention (Post)
Daily pain was assessed using the Visual Analogue Scale (VAS). The VAS is a single item linear self-reported pain scale from no pain (0mm) to worst pain imaginable (100mm). The clinically meaningful change for the VAS has been shown to be between 9mm and 12mm; for this study adopted the convention of 10mm as the minimum clinically important difference (MCID).
次要结局
- McGill Pain Questionnaire(Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks)
- Pittsburgh Sleep Quality Index(Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks)
- 12 Item Short Form Health Survey (SF-12) Physical Health Component Score(Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks)
- 12 Item Short Form Health Survey (SF-12) Mental Health Component Score(Before the start of the weekly VR session and after the weekly VR session for a period of 4 weeks)
研究者
Bernie Garrett
Associate Professor
University of British Columbia