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临床试验/NCT04572425
NCT04572425已完成不适用

Pilot Study to Evaluate Virtual Reality for Pain Management in Advanced Heart Failure

Medstar Health Research Institute2 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
94
试验地点
2
主要终点
Self reported pain score

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 heart failure pain in hospitalized patients with heart failure and compare this impact to that of 2-dimensional guided imagery distraction therapy.

详细描述

Through ongoing collaborative work between the MedStar Heart and Vascular Institute Advanced Heart Failure clinical team at our hospital and the MedStar Washington Hospital Center Palliative Care team, the research team identifies hospitalized patients with a primary diagnosis of heart failure (ACC/AHA stage C or D). Subjects 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 should be randomized with a 1:1 ratio to receive either one 10-minute VR session, or one 10-minute 2-dimensional guided-imagery session.

VR sessions will be administered using the Facebook (Facebook Inc., Menlo Park, CA) Oculus GO VR. The VR software that will be used is the Forest of Serenity (Holosphere VR®, Birmingham, UK) application. The guided-imagery session depicts a peaceful walk through a forest with instrumental background music and 2-dimensional imagery. Patients 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. Our 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.

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

入选标准

  • hospitalized at study institution
  • primary diagnosis of ACC/AHA Stage C or D heart failure
  • reports pain on 0-10 Likert scale at least 4/10 or greater

排除标准

  • (any of the following):
  • participant already uses virtual reality 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

Self reported pain score

时间窗: Immediately after assigned intervention

Likert scale 0 (no pain) to 10 (worst pain)

次要结局

  • Quality of life score(Immediately after assigned intervention)
  • Self reported distress(Immediately after assigned intervention)
  • Acceptability of intervention ("Would you use this intervention again?") -- this single question designed for this study(Immediately after assigned intervention)
  • Ease of intervention ("How easy was this technology for you to use?") -- this single question designed for this study(Immediately after assigned intervention)

研究者

发起方
Medstar Health Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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