Anxiety, POST-Covid 19
Conditions
Keywords
Long-Covid/ Post-Covid, CES, fatigue, insomnia
Brief summary
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.
Detailed description
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. Trial: 40 patients post-Covid reffered to inpatient PR will be recruited and allocated to one of two different groups. Group1: Anxious participants, Group 2: Non anxious participants. Within groups particpants will be randomized to intervention or control/sham. Intervention group will be using a functional device, and the other using a non-functional, SHAM device. Anxiety is evaluated using the Beck anxiety inventory on admission and at discharge from PR. Questionnaires to evaluate fatigue, depression and insomnia are the Fatigue Assessment Scale, PHQ-9, PSQI). A diary will be kept by each participant with a log of general health and mood over the PR program.
Interventions
DEVICEApplication of CES via ear clips
Use of 100µA CES for one hour per day over PR program
DEVICESham: No application of CES via ear clips
Use of Sham CES for one hour per day over PR programm
Sponsors
Schön Klinik Berchtesgadener Land
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
* acitve implants (cardiac pacemaker,...) * pregnancy, lactation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of symptoms of anxiety during intervention | Day 1 and Day 21 | Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue during intervention | Day 1 and Day 21 | Comparison of the FAS questionnaire pre and post pulmonary rehabilitation |
| Change in depression during intervention | Day 1 and Day 21 | Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation |
| Change in insomnia during intervention | Day 1 and Day 21 | Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation |
| Subjective effectiveness of device | Day 21 | Evaluation of the diary kept by the patient |
| Comfort while using the device | Day 21 | Evaluation of the diary kept by the patient |
| Change of general condition/ perceived well-being of the patient | Day 1 until Day 21 | Evaluation of the diary kept by the patient |
Countries
Germany
Outcome results
None listed