Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of symptoms of anxiety during intervention
研究概览
简要总结
The aim of the study is to investigate the effect of cranial electrotherapy stimulation (CES), for one hour a day over 3 weeks pulmonary rehabilitation (PR) program on symptoms of anxiety in post-Covid patients.
详细描述
Many patients recovering from Covid-19 develop sequelae related to the disease. In addition to lung issues, symptoms of Post-Covid/Long-Covid Syndrome include fatigue, brain fog, amyosthenia, insomnia, anxiety and depression. These symptoms play a major role in post-Covid patients recovery.
CES (Cranial electrotherapy stimulation) is a non-invasive therapy using low intensity alternating current applied through electrodes attached to the ear lobe.
CES has been used to improve the condition of non covid patients suffering from depression, anxiety, fatigue and cognitive disabilities. This is thought to be due to a change in electric waves of the brain with an increase of alpha-waves and a decrease of beta- and delta-waves, as well as a change of concentration of neurotransmitters, e.g. beta-endorphin or serotonin.
Therefore, this study aims to investigate the effect of CES in addition to normal PR, compared to PR alone on symptoms (e.g. anxiety) in post-Covid patients.
Hypothesis: Three weeks of PR including daily use of CES for one hour will have a positive effect on symptoms of anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Group with anxiety:
- •high Beck Anxiety Inventory Score
- •≥18 years
- •post SARS-CoV-2 infection
- •written consent
- •Group without anxiety:
- •low Beck Anxiety Inventory Score
- •≥18 years
- •post SARS-CoV-2 infection
- •written consent
排除标准
- •acitve implants (cardiac pacemaker,...)
- •pregnancy, lactation period
结局指标
主要结局
Change of symptoms of anxiety during intervention
时间窗: Day 1 and Day 21
Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation
次要结局
- Subjective effectiveness of device(Day 21)
- Change in insomnia during intervention(Day 1 and Day 21)
- Change in fatigue during intervention(Day 1 and Day 21)
- Change of general condition/ perceived well-being of the patient(Day 1 until Day 21)
- Comfort while using the device(Day 21)
- Change in depression during intervention(Day 1 and Day 21)
研究者
Prof. Dr. Andreas Rembert Koczulla
Head of Pneumological Department Affiliation: Schön Klinik Berchtesgadener Land
Schön Klinik Berchtesgadener Land