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临床试验/NCT06638918
NCT06638918已完成不适用

Assessing the Feasibility of a Virtual Reality Intervention for Lower Phantom Limb Pain in the Acute Postoperative Period

University of Manitoba1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月26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
20
试验地点
1
主要终点
Acceptability

研究概览

简要总结

The goal of this observational study is to see whether a new virtual reality (VR) program meant to treat phantom limb pain (PLP) is feasible to people immediately following lower limb amputation. This study aims to answer three questions.

  1. Is this VR treatment acceptable to people immediately following lower limb amputation?
  2. Are the researchers able to recruit participants that represent the population in need of this treatment, and will these participants stay until the end of the study?
  3. Do participants who use the VR program more have less severe PLP than participants who use the VR program for fewer sessions?

Participants will:

  • Try the VR program in the hospital, their home, and in physiotherapist clinics daily for about seventeen sessions.
  • After each session, participants will fill out questionnaires asking about their level of pain, their nausea, and how acceptable they find the program. They will also complete measures asking about how they're feeling and what led to their amputation.
  • One month following their final VR session, researchers will phone the participants to ask them to rate how severe their PLP is.

详细描述

There are many barriers that prevent people with lower limb amputations (LLA) from receiving effective nonpharmacological treatment for their phantom limb pain (PLP), such as long outpatient wait times and the sparse number of amputation rehabilitation specialists. Early administration of effective PLP treatments, such as graded motor imagery (GMI), may improve both treatment access and efficacy if it is administered through virtual reality (VR). However, no VR GMI treatments have been developed or tested in the acute postoperative period following LLA to prevent PLP. The current study will recruit 30 patients being treated for LLA at the Health Sciences Centre (HSC) in Winnipeg, Manitoba to assess the feasibility and pilot outcomes of a novel VR GMI program administered in the postoperative acute care setting, with the goal of preventing and or reducing PLP. First, the researchers predict the mean acceptability, tolerability, and length of engagement in the VR program will be high across administration contexts and each of the VR stages. Second, the researchers hypothesize the recruitment strategies employed will capture and retain a large, representative sample of individuals undergoing LLA at the HSC. Lastly, the researchers predict length of VR program engagement will demonstrate a preliminary effect on PLP incidence, intensity, and interference at one-month follow-up. Baseline characteristics such as anxiety, depression, and amputation etiology will also be explored as extraneous variables. This research will be the first to provide evidence for the feasibility of VR PLP treatment administered immediately following LLA. The results will inform future development of the VR program and optimize the study procedures for an upcoming randomized clinical trial.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • if they underwent or are about to undergo an LLA (hip, below-knee, above-knee, or foot) within the last two months
  • if they are currently receiving inpatient treatment at the Health Sciences Centre (HSC) in Winnipeg, Canada
  • if they can speak/read English fluently

排除标准

  • any visual, hearing, or motor impairment that would affect engaging with a head-mounted VR headset or hand controls, as interpreted by the research team or nursing staff

研究组 & 干预措施

Virtual Reality Group

These participants will receive the virtual reality intervention for at least 20 minutes daily for approximately seventeen sessions, or as long as they are able.

干预措施: Virtual Reality (Device)

结局指标

主要结局

Acceptability

时间窗: Immediately after intervention is administered

The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.

Tolerability of the virtual reality simulation

时间窗: Immediately before and after intervention administration

Numerical Rating Scale for phantom limb pain, residual limb pain (i.e., physical pain at the amputation site), nausea (NRS \> 2 on any construct indicates an adverse event and lack of tolerability). Range 0-10 on each NRS.

Engagement

时间窗: During intervention administration, up to seventeen days

Length of time in minutes spent in the virtual reality program per session (recommended: 20 minutes)

次要结局

  • Phantom Limb Pain Intensity(One month follow-up)
  • Phantom Limb Pain Interference(One month follow-up)
  • Embodiment(Administered after intervention administration is completed, up to seventeen days)
  • Presence(Administered after intervention administration is completed, up to seventeen days)

研究者

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

Renée El-Gabalawy

Associate Professor & Clinical Psychologist

University of Manitoba

研究点 (1)

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