NOICE: A Prospective, Randomized, Crossover Study (NOICE vs. Nothing)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
This prospective, randomized, 2-period crossover study seeks to evaluate the effect of the non-visual immersive technology-based audio biofeedback intervention, delivered through devices such as NOICE device or Quest 3, on cold pain threshold within participants.
详细描述
This study addresses the research gap in understanding how non-visual immersive technology-based audio biofeedback intervention impacts pain perception in clinical settings. It is important to explore this because non-visual immersive technology-based audio biofeedback intervention may serve as a non-pharmaceutical, non-visual immersive technology-based audio biofeedback alternative to traditional visual-based distraction methods like virtual reality.
The investigators hypothesize that participants using the non-visual immersive technology-based audio biofeedback device will report an increased pain threshold compared to not using the device. This knowledge could improve information on the perception of pain for participant who prefer not to use Virtual Reality (VR) headsets.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 交叉
- 主要目的
- 支持治疗
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Ages 18 years and older
- English-speaking
- Intact hearing
- No self-reported or clinically diagnosed acute or chronic medical conditions that may affect safe participation
排除标准
- Use chronotropic heart medications
- Use pain medications
- Current hearing loss
- Currently taking beta blockers, or opioids or other prescription pain medications
- History of chronic pain or acute pain syndromes
研究组 & 干预措施
Group 1
Participants first perform the task with non-visual immersive technology-based audio biofeedback using the dominant hand, followed by without non-visual immersive technology-based audio biofeedback using the non-dominant hand.
干预措施: Non-visual immersive technology-based audio biofeedback intervention (Behavioral)
Group 1
Participants first perform the task with non-visual immersive technology-based audio biofeedback using the dominant hand, followed by without non-visual immersive technology-based audio biofeedback using the non-dominant hand.
干预措施: Control (No non-visual immersive technology-based audio biofeedback) (Behavioral)
Group 2
Participants first perform the task with non-visual immersive technology-based audio biofeedback using the non-dominant hand, followed by without non-visual immersive technology-based audio biofeedback using the dominant hand.
干预措施: Non-visual immersive technology-based audio biofeedback intervention (Behavioral)
Group 2
Participants first perform the task with non-visual immersive technology-based audio biofeedback using the non-dominant hand, followed by without non-visual immersive technology-based audio biofeedback using the dominant hand.
干预措施: Control (No non-visual immersive technology-based audio biofeedback) (Behavioral)
Group 3
Participants first perform the task without non-visual immersive technology-based audio biofeedback using the dominant hand, followed by with non-visual immersive technology-based audio biofeedback using the non-dominant hand.
干预措施: Non-visual immersive technology-based audio biofeedback intervention (Behavioral)
Group 3
Participants first perform the task without non-visual immersive technology-based audio biofeedback using the dominant hand, followed by with non-visual immersive technology-based audio biofeedback using the non-dominant hand.
干预措施: Control (No non-visual immersive technology-based audio biofeedback) (Behavioral)
Group 4
Participants first perform the task without non-visual immersive technology-based audio biofeedback using the non-dominant hand, followed by with non-visual immersive technology-based audio biofeedback using the dominant hand.
干预措施: Non-visual immersive technology-based audio biofeedback intervention (Behavioral)
Group 4
Participants first perform the task without non-visual immersive technology-based audio biofeedback using the non-dominant hand, followed by with non-visual immersive technology-based audio biofeedback using the dominant hand.
干预措施: Control (No non-visual immersive technology-based audio biofeedback) (Behavioral)
结局指标
主要结局
Pain score
时间窗: Immediately after intervention
Pain sensitivity will be measured by Numerical Rating Pain Scale. Participants will rank pain scores on a sliding scale from 0 = No Pain to 10 = Worst possible pain
次要结局
- Anxiety Level(Immediately after intervention)
- Cold pain endurance(Periprocedural)
- ISO Ergonomic scale(immediately after intervention)
- System Usability Scale (SUS) Score(immediately after intervention)
- Device satisfaction(immediately after intervention)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07227142
- 其他研究编号
- 83700
日期
- 首次提交
- (10个月前)
- 首次发布
- (10个月前)
- 主要完成日期
- (6个月前)
- 研究完成日期
- (6个月前)
- 最近核实
- (5个月前)
- 最近更新
- (4个月前)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否