Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- POST-Covid 19
- Sponsor
- Schön Klinik Berchtesgadener Land
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change of symptoms of anxiety during intervention
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Prof. Dr. Andreas Rembert Koczulla
Head of Pneumological Department Affiliation: Schön Klinik Berchtesgadener Land
Schön Klinik Berchtesgadener Land
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change of symptoms of anxiety during intervention
Time Frame: Day 1 and Day 21
Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation
Secondary Outcomes
- 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)