The Effect of the Human Regenerator Jet Device on the Quality of Life of Adult Individuals [HR-QoL]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- EURO-QOL Quality of Life Health Assessment (License no. 62101)
研究概览
简要总结
This cross-over single-blinded study aims to evaluate the effect of a novel cold atmospheric plasma jet-producing device, the Human Regenerator Power Jet device, for individuals who suffer from chronic stress, chronic pain, chronic fatigue, sleep disorders, and Post-COVID/Long-COVID Syndrome, all conditions that affect the QoL among adults in Greece and worldwide.
详细描述
Introduction: Plasma medicine is a novel, exciting, young interdisciplinary scientific field, emerging from the interaction of physicists, biologists, and medical doctors. Plasma is the fourth matter, often defined as an ionized gas produced by the disintegration of polyatomic gas molecules or the removal of electrons from monatomic gas shells, with the following strict criteria: plasma must be a) macromolecularly neutral (quasi-neutrality); b) Debye shielding; c) frequency. As a result, plasma can be defined as "a quasi-neutral gas containing many interacting free electrons and ionized atoms and molecules, which have collective behavior caused by long-range coulomb forces", and their motion gives rise to electric fields and generates currents and magnetic fields. Plasma is classified into high-temperature, thermal, and non-thermal categories. In high temperature, all particles (both electrons and heavy particles) have the same temperature, and are thus in thermal equilibrium. Non-thermal (non-equilibrium) plasma engulfs particles that are not in thermal equilibrium. This plasma is termed "cold plasma". Cold plasma discharge can be achieved at both low pressure and atmospheric pressure. Low pressure cold plasma was first applied for surface decontamination in a more effective manner than conventional sterilization in the 1960s; by contrast, Cold Atmospheric Plasma (CAP) was applied in 1990s.
CAP is ideal for use in modern medicine because : a) it can be generated easily from a portable device with easier direct access to affected cells and tissues, b) all animal and human tissues contain water and its presence is undesirable in low pressure conditions, c) its ability to reduce microbial load makes it a good option to combat increasing antibiotic resistance, and d) CAP-generating devices have relatively low manufacturing costs. As a result, accessible, efficient, and inexpensive CAP devices can reduce the financial burden imposed on the health budget by conventional treatments.
All plasma devices used in clinical practice are intended to prevent harm to healthy cells. They undergo multistep testing and are associated with no significant side effects. Nevertheless, the proper CAP dosage must be continuously monitored, adjusted for each treatment, with an important parameter to be the distance between the plasma jet source and human skin. Hypothetically speaking, it could not be excluded that CAP does not have some minimal negative effects at the molecular level; these are still subject to ongoing analysis, but results so far suggest that hypothetically unproven adverse effects are outweighed by the enormous benefits of CAP.
Current analyses of CAP effects have concentrated mostly on cells in culture and animal models. Although these efforts are more accessible and easier to conduct, wider testing of CAP effects in disease and regenerative medicine studies in human patients could only be beneficial. Nowadays, CAP is mostly employed in aesthetic procedures; however, its use in more serious medical conditions, such as acute and chronic wounds, oral bacterial infections, and potentially in tumour therapy, is subject to ongoing research. The use of CAP in routine clinical practice in medicine could advance the therapeutic process into a less invasive and distressing process for patients, while also significantly reducing the financial burden of existing treatments in Europe and worldwide.
Aim of the Study: This cross-over single-blinded study evaluates the effect of a novel CAP jet-producing device, the Human Regenerator Power Jet (CE 2022), for individuals who suffer from chronic stress, chronic pain, chronic fatigue, sleep disorders, and Post-COVID/Long-COVID Syndrome, all conditions that affect the QoL among adults in Greece and worldwide [HR-QoL].
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 94 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and laboratory diagnosis of chronic stress/chronic pain/chronic fatigue/Long Covid Criteria:
排除标准
- •Pregnancy or Breast-feeding period
- •Participation on another Stress related study
- •Patients with implanted devices
- •Patients with major psychiatric disorders
- •Refusal to participate in the study
研究组 & 干预措施
CAP to AIR
Group A (20 adults) were subjected to Cold Atmospheric Plasma (10 sessions) generated by the Human Regenerator jet device (Active Device-CAP Effect), followed by a 1-month wash-out period, before being subjected to AIR (10 sessions) (Sham Device-Placebo Effect).
干预措施: Cold Atmospheric Plasma (Device)
CAP to AIR
Group A (20 adults) were subjected to Cold Atmospheric Plasma (10 sessions) generated by the Human Regenerator jet device (Active Device-CAP Effect), followed by a 1-month wash-out period, before being subjected to AIR (10 sessions) (Sham Device-Placebo Effect).
干预措施: Atmospheric Air (Device)
AIR to CAP
Group B (20 adults) were subjected to AIR (10 sessions) generated by the Human Regenerator jet device (Sham Device-Placebo Effect) followed by a 1-month wash-out period, before being subjected to Cold Atmospheric Plasma conditions (10 sessions) (Active Device-Cap Effect)..
干预措施: Cold Atmospheric Plasma (Device)
AIR to CAP
Group B (20 adults) were subjected to AIR (10 sessions) generated by the Human Regenerator jet device (Sham Device-Placebo Effect) followed by a 1-month wash-out period, before being subjected to Cold Atmospheric Plasma conditions (10 sessions) (Active Device-Cap Effect)..
干预措施: Atmospheric Air (Device)
结局指标
主要结局
EURO-QOL Quality of Life Health Assessment (License no. 62101)
时间窗: The time frame ranges from enrollment to completion in 10-11 weeks, with four time points: T1: Enrollment date; T2: 3 weeks; T3: 7 weeks; T4: 10 weeks-Completion date.
The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in and it essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions (1-digit number/dimension), The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state and reflects to the overall health state of each individual (0-1 scale). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image' (0-100 scale).
次要结局
未报告次要终点
研究者
Eumorphia Remboutsika
Researcher B ( Associate Professor Level)
University Research Institute for the Study of Genetic & Malignant Disorders in Childhood
