Symptom Management in the Bone Marrow Transplant Patient Population Using Virtual Reality
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Difference in the trajectories of the mean Edmonston Symptom Assessment System Revised (ESAS-r) composite scores
研究概览
简要总结
This clinical trial compares the use of virtual reality to standard care for improving symptom management in patients undergoing hematopoietic stem cell transplantation (HSCT). Significant symptoms experienced by hospitalized HSCT patients include, but are not limited to, depression, tiredness, anxiety, drowsiness, lack of appetite, pain, and overall decreased quality of life and well-being. Virtual reality (VR) as an intervention can provide these patients with a much-needed escape from their reality and has proven results in clinical settings as a distraction therapy. VR technology targets the patient's auditory, visual, and physical contact/touch senses, and has been evidenced to improve depression, fatigue, anxiety, appetite, and pain. Virtual reality may improve symptom management in patients undergoing HSCT.
详细描述
PRIMARY OBJECTIVE:
I. To determine the efficacy of VR for symptom management in the admitted HSCT patient population.
SECONDARY OBJECTIVE:
I. To examine the use of supportive medications for symptom management after HSCT while using VR.
EXPLORATORY OBJECTIVE:
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
- 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
- •Adult patients (≥ 18 years old) admitted to Roswell Park on 5 North for planned hematopoietic stem cell transplantation (HSCT)
- •Must be alert and oriented (Glascow Coma Scale of 15, Nursing Universal Flowsheet) and able to consent to participate in the study
- •Expected to be admitted to Roswell Park inpatient unit for ≥ 1 week
- •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant patients
- •Incarcerated patients
- •Patients who are unwilling or unable to follow protocol requirements
- •Individuals that are prone to motion sickness, nausea, dizziness, history of seizure, potential for seizure, history of delirium, at risk for confusion, etc
- •Participants with audio and/or visual impairments that would preclude them from using a VR device
研究组 & 干预措施
Arm I (VR use)
Patients use the VR device to participate in applications related to relaxation such as mediation, art and nature, for up to 15 minutes, daily, while inpatient for standard of care HSCT.
干预措施: Survey Administration (Other)
Arm I (VR use)
Patients use the VR device to participate in applications related to relaxation such as mediation, art and nature, for up to 15 minutes, daily, while inpatient for standard of care HSCT.
干预措施: Virtual Reality (Procedure)
Arm I (VR use)
Patients use the VR device to participate in applications related to relaxation such as mediation, art and nature, for up to 15 minutes, daily, while inpatient for standard of care HSCT.
干预措施: Interview (Other)
Arm II (Standard care)
Patients undergo standard care for the HSCT.
干预措施: Best Practice (Other)
Arm II (Standard care)
Patients undergo standard care for the HSCT.
干预措施: Survey Administration (Other)
结局指标
主要结局
Difference in the trajectories of the mean Edmonston Symptom Assessment System Revised (ESAS-r) composite scores
时间窗: Length of hospital stay up to 6 months
Firstly, the pattern of ESAS-r scores over time will be graphically examined. To account for the within-individual correlations, a generalized linear mixed model with appropriate link function will be applied. The time is measured by the number of days after treatment start and will be considered as a continuous variable. The effect of interest is the time by group interaction. Significant interaction implies different trajectories of ESAS-r composite scores over time. If the nonlinear patterns were observed, appropriate transformation or analyses focusing on the linear region will be considered. All tests will be two sided at a significant level of 0.05. Scores of individual items will be compared using the same approach. False discovery rate will be controlled using Benjamini-Hochberg procedure. As complementary analyses, models with only surveys before or after the virtual reality will also be examined.
次要结局
- Counts of supportive medication administration(Length of hospital stay up to 6 months)