NCT05293275Unknown不适用
Virtual Reality as Nonpharmacologic Pain Management Among Hospitalized Inpatients. A Randomized Control Trial of Virtual Reality vs Standard of Care
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Pain assessed by Numerical Pain Rating Scale
研究概览
简要总结
Investigating pain in hospitalized patients in two groups: virtual reality usage group vs standard of care
详细描述
Patients will be randomized to either the virtual reality group or the standard of care group. The virtual reality group will use the device over two days. Both groups will answer questionnaires regarding their pain and anxiety. Medical records will be used to look at pain medication usage in both groups.
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
- 是
入选标准
- •• patients at least 18 years of age,
- •reported pain in last 24 hours ≥ 3 on the Numerical Rating Scales (NRS),
- •patients undergoing surgery,
- •expected hospital length of stay of at least 48 hours,
- •English fluency,
- •willing to comply with study procedures.
- •Hx opioid use
排除标准
- •• gross cognitive impairment that would interfere with the ability to consent or complete study procedures
- •current or prior diagnosis of epilepsy, seizure disorder, dementia, or migraines,
- •hypersensitivity to flashing light or motion,
- •history of motion sickness or cyber sickness,
- •medical condition predisposing to or current nausea, vomiting or dizziness,
- •stereoscopic vision or severe hearing impairment,
- •injury to eyes, face or neck that impedes comfortable use of virtual reality,
- •cancer related pain,
- •PHQ-9 screen indicating suicidal ideation, patients will be referred to appropriate clinical intervention (see suicide protocol)
- •currently pregnant,
- •current or recent completion of participation in any interventional pain study (with in past 2 months)
- •substance abuse (alcohol or illegal drugs): Alcohol- NIAAA definition of heavy drinking as more than 4 drinks on any day or more than 14 drinks per week for men, more than 3 drinks on any day or more than 7 drinks per week for women. Any illegal drugs including marijuana
结局指标
主要结局
Pain assessed by Numerical Pain Rating Scale
时间窗: 3-4 days
level of pain will be assessed using the Numerical Pain Rating Scale. The scale is composed of 0 (no pain) to 10 (worst pain imaginable)
次要结局
- Anxiety assessed with numerical scale(3-4 days)
- The PROMIS sleep disturbance questionnaire(3-4 days)
研究者
Mark B Powers
Research Center Director Trauma Research Consortium
Baylor Research Institute
研究点 (6)
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