Pilot Study to Investigate the Use of Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention.
研究概览
简要总结
This study aims to evaluate the use of virtual reality as an adjunct to standard care for patients with sickle cell disease experiencing vaso-occlusive crises.
详细描述
A prospective, non-blinded, non-randomized trial will be conducted at the Adult Emergency Department at the University of Maryland Medical Center and Adult Urgent Care Center, which is managed by the Department of Emergency Medicine, located in Baltimore, Maryland.
Patients meeting eligibility criteria and who have signed the research informed consent will be enrolled in this study. Subject data collected will include demographic information, symptoms of the current illness and physical exam findings.
Upon enrollment into the study, a study team member will interview the patient to collect data needed to complete the Case Report Form. Patients assigned to one of the two virtual reality study groups will be directed by research coordinators who can help with equipment as needed throughout the session. The virtual reality device will be limited to a maximum of 2 hours of use. Assessments will be made at 4 different timepoints: 1) Immediately before the intervention, 2) at the 1-hour mark of the intervention, 3) immediately after the intervention, and 4) 1 hour after the intervention. During these assessments, patients will rate their pain intensity using a 0-10 numerical scale. Additionally, at each assessment, patients will be asked to state the change in pain that has taken place since the last measurement. This measurement will be performed without informing the patient of their previously recorded pain scores.
Data will also be recorded regarding the patient's 1) comfort of the device, 2) disposition (discharged home vs observation/admission status), 3) total length of treatment time in the ED (measured as time to initiation of any treatment to the time of final disposition), and 4) total amount of opioids administered while under the care of the emergency department clinicians, converted into morphine milligram equivalents. Each patient will complete a questionnaire at the conclusion of the session regarding their perceived impact of the intervention, ease of use, and likelihood to reuse the intervention.
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
盲法说明
Once the participant has been enrolled in the study, they will be randomized to either the control arm or one of the experimental arms. No masking is being performed. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in.
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 (age > 18 years) emergency department patient
- •History of sickle cell disease
- •Presenting to the emergency department due to acute pain related to sickle cell disease thought to be due to vaso-occlusive crisis
排除标准
- •Prior enrollment in this study
- •Presenting with a chief complaint suggestive of a complicated crisis (such as concern for acute chest syndrome, splenic sequestration, hepatic sequestration, pulmonary embolism) as determined by the clinical care provider
- •Not being treated with intravenous opioids for the vaso-occlusive crisis
- •Patients who lack the capacity to provide informed consent
- •Medical history of seizures or known intolerance to virtual reality
- •Disabilities like vision and hearing defects etc. that preclude the use of a head mounted virtual reality device.
- •Known to be pregnant
- •Incarcerated at the time of evaluation
- •Over the age of 89 years old
结局指标
主要结局
Comparison of the change in pain scores between the 3 groups at one hour after completion of the study intervention.
时间窗: A single time point 1 hour after the study intervention ends.
Patient reported on 0-10 scale
次要结局
- Comparison of the proportion of subjects within each group who are hospitalized.(Day of enrollment)
- Compare the total duration of Emergency Department treatment measured from the time of delivery of the first intervention to the time of disposition.(Day of enrollment)
- Comparison of the subject's assessment of comfort of the study intervention between the 3 groups(Immediately before intervention, at 1-hour mark of the intervention, immediately following the intervention, and 1 hour after the intervention ends.)
- Comparison of the quantity opioids, converted to morphine milligram equivalents, administered while under the care of the ED clinical team.(Day of enrollment)
- Comparison of the change in pain scores between the 3 groups at one hour after study intervention begins.(A single time point 1 hour after the study intervention begins.)
- Comparison of the change in pain scores between the 3 groups at completion of the study intervention.(A single time point at the completion of the study intervention.)
研究者
Richard Gentry Wilkerson
Associate Professor
University of Maryland, Baltimore