Cardio-visual Stimulation in Augmented Reality for Pain Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in perceived pain
研究概览
简要总结
The objective of this study is to evaluate the feasibility and efficacy of an Augmented Reality (AR) biofeedback intervention to alleviate pain symptoms in individuals suffering from chronic pain of the hand and/or the forearm.
详细描述
Chronic pain is a major public health problem with implications for high health care costs, lost productivity and an estimated financial burden of $500 billion. Individuals with chronic pain are also at an increased risk of developing an opioid use disorder.
Chronic pain has previously been associated with a distorted body representation, in particular of the affected body parts. Virtual Reality (VR) studies using embodiment-, respiration-, and heart-beat related feedback have demonstrated positive effects for induced pain in healthy participants (e.g., increased pain thresholds) and chronic pain in patient populations (e.g., decreased subjective pain, improved functionality, improved physiological markers of pain). Based on these studies, the AR intervention evaluated here aims to alleviate subjective pain symptoms and improve physiological pain markers in chronic pain patients using heartbeat-related feedback.
This within-subject study will compare subjective pain ratings before, during, and after an AR intervention that provides visual feedback of participants' on-going heartbeat in relation to their affected limb. Primary outcomes include subjective reports from participants (perceived efficacy, acceptability, and demand) and the intervention's clinical feasibility, including reports from therapists. Secondary outcomes include changes in heart rate and variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Be over 18 years of age
- •Present permanent chronic pain (for more than 3 months), secondary to a peripheral pathology (traumatic, orthopedic or neurological), located in the hand or forearm.
排除标准
- •Pregnant women
- •People in emergency situations
- •Persons unable to give informed consent
- •Persons who are mentally or linguistically unable to understand the research test instructions
- •Individuals who are not available to complete the entire study protocol
- •Cognitive impairments that prevent the use of the equipment
- •Psychiatric disorders
- •Patients with seizure disorders
- •Patients with central hemineglect
- •Pain secondary to central nervous system pathology
- •Patients with arrhythmia
- •Patients with head tremors or head shaking.
结局指标
主要结局
Change in perceived pain
时间窗: change in pain rating will be evaluated when participants first wear the Head-Mounted Display (baseline), after 3 minutes of video-passthrough (Pre), after 3 minutes of cardio-visual stimulation (post), after 3 minutes of video-passthrough (final)
The patient moves a cursor on a Visual Analog Scale to indicate their currently perceived level of pain. The gauge ranges from "no pain" (0) to "worst pain imaginable" (10).
Change in Heart-Rate Variability (frequency domain)
时间窗: a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
frequency-domain metric of heart-rate variability (power)
Change in Heart-Rate Variability (time domain)
时间窗: a change in heart-rate variability will be evaluated between baseline (pre), intervention, and immediately following intervention (post)
time-domain metrics of heart-rate variability \[ms\]
次要结局
- Questionnaire(The fourth day of the study)
研究者
Amélie Touillet
Principal Investigator
Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est