Evaluation of a Specialized Therapeutic Care of Patients Presenting an Idiopathic Environmental Intolerance Attributed to Electromagnetic Fields
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Measurement of symptoms severity
研究概览
简要总结
The purpose of the study is to evaluate efficacy of a 14 months follow-up and individual medical care of electro-sensitive patients: by measurement of health status, sensitivity to electromagnetic fields exposures, and quality of life.
详细描述
110 patients suffering from Idiopathic Environmental Intolerance attributed to electromagnetic fields (IEI-EMF) are expected in this trial.
Type of trial: Interventional multicenter study, non-randomized, with measurement before and after intervention. Each patient is his own control.
Primary outcome: Efficacy of an individual medical care on electro sensitive (IEI CEM) patients evaluated from the improvement of health status, sensitivity to electromagnetic fields (EMF) exposure, and quality of life.
Scheme:
Visit 1(T0): Patients undergo a specialized medical examination: a standardized medical record is filled in. Physicians evaluate the psychological impact of IEI-EMF and a psychotherapeutic care is proposed if necessary. Patients fill in 2 self-questionaries: quality of life (SF-36) and EMF exposure sensitivity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Subjects who declare themselves to be intolerant to electromagnetic fields
- •Subjects over 18 years old
- •Subjects affiliated to a social security scheme
- •Subjects who signed the consent form
排除标准
- •Subject with a disorder of the understanding of the French language at the discretion of the investigator
- •Pregnant women,
- •Persons deprived of their liberty, persons under guardianship, and persons in emergency situations.
研究组 & 干预措施
Experimental
Patients who declare themselves to be intolerant to electromagnetic fields benefit from medical care in occupational and environmental diseases centers and from a measurement of individual electromagnetic exposures and symptoms episodes. Each patient is his own control.
干预措施: Individual medical Care (Other)
Experimental
Patients who declare themselves to be intolerant to electromagnetic fields benefit from medical care in occupational and environmental diseases centers and from a measurement of individual electromagnetic exposures and symptoms episodes. Each patient is his own control.
干预措施: Individual electromagnetic exposures (Other)
结局指标
主要结局
Measurement of symptoms severity
时间窗: At 1 month after inclusion
At month 1 month the severity of symptoms is evaluated by a self-questionary filled in during 7 days. The level of severity of each symptom occurring during a week, will be self-evaluated by the patient on the base of a 0 to 5 scale. Following the intervention we expect a reduction in the severity of symptoms described.
Measurement of symptoms frequency
时间窗: At 1 month after inclusion
At month 1 months the symptoms frequency is evaluated by a self-questionary filled in during 7 days. Each symptom occurring during a week is reported by the patient allowing calculation of a frequency in symptoms appearance. Following the intervention we expect a reduction in the frequency of symptoms described.
Sensitivity to electromagnetic fields
时间窗: at day 0
At visit 1 (day 0), the EMF sensitivity is evaluated by the self-questionary.
次要结局
- Quality of life evaluation(day 0)
- Compliance to the study design(At each Visit (Day 0, Month 1, Month 6 and month 14))