Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change of symptoms of anxiety during intervention
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Post-Covid patients, non anxious, Sham
Use of Sham CES for one hour per day by non anxious patients
Intervention: Sham: No application of CES via ear clips (Device)
Post-Covid patients, anxious, functional device
Applitation of 100µA CES for one hour per day to anxious patients
Intervention: Application of CES via ear clips (Device)
Post-Covid patients, anxious, Sham
Use of Sham CES for one hour per day by anxious patients
Intervention: Sham: No application of CES via ear clips (Device)
Post-Covid patients, non anxious, functional device
Application of 100µA CES for one hour per day to non anxious patients
Intervention: Application of CES via ear clips (Device)
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
- Change of general condition/ perceived well-being of the patient(Day 1 until Day 21)
- Comfort while using the device(Day 21)
- 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 in depression during intervention(Day 1 and Day 21)
Investigators
Prof. Dr. Andreas Rembert Koczulla
Head of Pneumological Department Affiliation: Schön Klinik Berchtesgadener Land
Schön Klinik Berchtesgadener Land