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临床试验/NCT04301440
NCT04301440已完成不适用

THE PHYSIOLOGICAL EFFECTS OF ELECTROMAGNETIC EMISSIONS ON THE GENERAL CONDITION OF THE PATIENT

Clinique Bizet2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Improved quality of life in depressed and anxiety patients: Hospital Anxiety and Depression scale

研究概览

简要总结

Hospital patients usually experience anxiety caused by physiological, psychological and environmental stimuli. This emotional state corresponds to the psychophysiological response to a perceived threat.

The investigator's goal is to use a non-drug approach to these problems which would help improve the quality of life of patients, prevent the consumption of anti-anxiety drugs / antidepressants; and thus to reduce the direct cost in terms of treatment, but also to reduce the indirect costs linked to work stoppages and the consumption of the care offer.

Working hypothesis: Local magnetic muscle stimulation improves people's well-being and relaxation

详细描述

Primary objective :

Describe the effect of the intervention on the level of anxiety / depression in patients with anxious and / or depressive characteristics

Secondary objectives:

  • Describe the variation in the quality of life of patients before and after the intervention
  • Describe the variation in drug consumption
  • Describe the use of post intervention hospitalization
  • Describe the variation in the quality of sleep before and after the intervention
  • Describe the timeframe for returning patients to professional activity

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

入选标准

  • Major patient hospitalized for the management of a chronic pathology and / or its complications;
  • Patient with a Hospital Anxiety and Depression scale score (HAD) ≥ 8 for items assessing anxiety disorders; AND a HAD score ≥ 8 for the items assessing depressive disorders.
  • Subject affiliated to a social security scheme or beneficiary of such a scheme
  • No participation in another clinical study

排除标准

  • Minor patient
  • Pregnant and breastfeeding women
  • HAD score <8 for items evaluating anxiety disorders OR a HAD score <8 for items evaluating depressive disorders
  • Major subject protected by law, under curatorship or tutorship

结局指标

主要结局

Improved quality of life in depressed and anxiety patients: Hospital Anxiety and Depression scale

时间窗: Ten days

Evaluation with Hospital Anxiety and Depression scale

Improved quality of sleep: Epworth scale

时间窗: Ten days

Evaluation with Epworth scale

Decreased consumption of anti-anxiety and anti-depressant drugs

时间窗: Ten days

Prescription analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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