Pilot Study to Evaluate Virtual Reality for Cancer Pain Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Change in self-reported pain score from baseline to immediately after assigned intervention
研究概览
简要总结
The purpose of this research project is to evaluate the impact of virtual reality therapy on mitigating cancer pain in hospitalized patients with cancer and compare this impact to that of 2-dimensional guided imagery distraction therapy. The purpose is also to evaluate acceptability of and satisfaction with virtual reality therapy and to examine racial and cultural preferences related to virtual reality and guided imagery thematic content.
详细描述
Subjects hospitalized at MedStar Washington Hospital Center will be considered for enrollment in this study if able to provide consent, at least 18 years old, and report moderate-severe pain (at least 4 out of 10 where pain is rated on a Likert scale between zero and 10) in the previous 24 hours. Subjects will be excluded if they already use VR for personal use, have intractable nausea/vomiting, history of motion sickness, history of seizures or epilepsy, have cranial structure abnormalities that prevent use of VR headset, are currently enrolled in a palliative care or pain management study, and/or are on contact isolation. Institutional review board approval will be sought and informed consent will be conducted before enrolling every patient.
After consenting to participate, in addition to usual pharmacologic pain management, 128 patients will be randomized with a 1:1 ratio to receive either one 10-minute VR session, or one 10-minute 2-dimensional guided-imagery session. The investigators believe this sample size is easily achievable given current palliative consult volumes for patients with cancer at the study institution (see above); this sample size accounts for estimates that only approximately half of eligible subjects are interested in trying VR therapies.
VR sessions will be administered using the Facebook (Facebook Inc., Menlo Park, CA) Oculus Quest VR and Touch controllers. This equipment was selected because it is portable and can be set up at the bedside in private or shared patient rooms. The hand controllers facilitate immersive, interactive VR experiences for patients who may be bedbound or have limited mobility in the inpatient setting. The VR software, Forest of Serenity (Holosphere VR ®, Birmingham, UK) is a free application that features seven non-violent mini-games in a carnival environment that can be played in a seated or fixed position.
The guided-imagery session depicts a peaceful walk through a forest with instrumental background music and 2-dimensional imagery. Subjects will watch the guided imagery video on a portable tablet for 10 minutes, the same duration as the VR intervention. Subjects in both arms will continue to receive standard pharmacologic pain management. Because of the nature of the compared interventions, subjects and researchers cannot be blinded to intervention.
The primary outcome measure will determine the impact of distraction therapy (either VR therapy or 2-dimensional guided imagery) on self-reported pain experience. Self-reported pain experience remains the standard for clinical pain research. Secondary outcomes will measure impact of each distraction therapy on general distress level, general quality of life, and satisfaction with pain management. For patients receiving opioid therapies for pain in the preceding 24 hours, the investigators will also evaluate "as needed" opioid use.
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalized, with primary diagnosis of cancer
- •age 18 and older
- •report moderate-severe pain (at least 4 out of 10 where pain is rated on a Likert scale between zero and 10) in the previous 24 hours
排除标准
- •already use VR for personal use
- •intractable nausea/vomiting
- •history of motion sickness
- •history of seizures or epilepsy
- •have cranial structure abnormalities that prevent use of VR headset
- •currently enrolled in a palliative care or pain management study
- •on contact isolation
结局指标
主要结局
Change in self-reported pain score from baseline to immediately after assigned intervention
时间窗: Baseline and again immediately after assigned intervention
Likert scale 0 (no pain) to 10 (worst pain)
次要结局
- Change in self-reported quality of life from baseline to immediately after assigned intervention(Immediately after assigned intervention)
- Change in self-reported distress from baseline to immediately after assigned intervention(Baseline and immediately after intervention, 24 hours after intervention)
- Level of immersion experienced in virtual reality arm(Immediately after intervention (virtual reality arm only))
- Ease of intervention ("How easy was this technology for you to use?") -- this single question designed for this study(Immediately after assigned intervention)
- Acceptability of intervention ("Would you use this intervention again?") -- this single question designed for this study(Immediately after intervention)
- Change in self reported distress from baseline to Immediately after assigned intervention(Immediately after assigned intervention)
研究者
Hunter Groninger
Associate Professor of Medicine
Georgetown University
