NOICE vs. Nothing | Thermode: A Prospective, Randomized, Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in heat pain threshold
研究概览
简要总结
The purpose of this study is to test whether the non-visual immersive technologies, which uses spatial audio simulation, can help people better tolerate heat pain. As a proof-of-concept study, study team will use the NOICE device. This research is not studying the NOICE device specifically and the device is not a medical device.
详细描述
This study addresses the research gap in understanding how spatial audio impacts pain perception, specifically heat pain, in clinical settings. It is important to explore this because spatial audio may serve as a non-pharmaceutical, immersive alternative to traditional visual-based distraction methods like virtual reality.
The investigators hypothesize that participants using the spatial audio simulation device will report an increased heat 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 VR headsets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
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 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
- •Current hearing loss
研究组 & 干预措施
Spatial audio stimulation
Participant will receive spatial audio stimulation first and then will not receive spatial audio stimulation in the latter part of the study.
干预措施: Spatial audio stimulation (Behavioral)
Spatial audio stimulation
Participant will receive spatial audio stimulation first and then will not receive spatial audio stimulation in the latter part of the study.
干预措施: No spatial audio stimulation (Behavioral)
No spatial audio stimulation
Participant will not receive spatial audio stimulation first and then will receive spatial audio stimulation in the latter part of the study.
干预措施: No spatial audio stimulation (Behavioral)
No spatial audio stimulation
Participant will not receive spatial audio stimulation first and then will receive spatial audio stimulation in the latter part of the study.
干预措施: Spatial audio stimulation (Behavioral)
结局指标
主要结局
Change in heat pain threshold
时间窗: Duration of intervention, approximately 15 minutes
Heat pain threshold measured by the TSA Air II device. Temperature ranges from 32 degrees C to 44 degrees C, with higher temperatures indicating a higher heat pain threshold.
Change in heat pain threshold
时间窗: Duration of intervention, approximately 15 minutes
Heat pain threshold measured by the TSA Air II device. Temperature ranges from 32 degrees C to 44 degrees C, with higher temperatures indicating a higher heat pain threshold.
次要结局
- Change in heat pain sensitivity (HPS)(immediately after intervention)
- Anxiety Level(immediately after intervention)
- ISO Ergonomic scale(immediately after intervention)
- System Usability Scale (SUS) Score(immediately after intervention)
- Device satisfaction(immediately after intervention)
研究者
Thomas Caruso
Clinical Professor
Stanford University