Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19
NCT ID: NCT05126511
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2021-11-19
2022-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Post-Covid patients, anxious, functional device
Applitation of 100µA CES for one hour per day to anxious patients
Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program
Post-Covid patients, anxious, Sham
Use of Sham CES for one hour per day by anxious patients
Sham: No application of CES via ear clips
Use of Sham CES for one hour per day over PR programm
Post-Covid patients, non anxious, functional device
Application of 100µA CES for one hour per day to non anxious patients
Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program
Post-Covid patients, non anxious, Sham
Use of Sham CES for one hour per day by non anxious patients
Sham: No application of CES via ear clips
Use of Sham CES for one hour per day over PR programm
Interventions
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Application of CES via ear clips
Use of 100µA CES for one hour per day over PR program
Sham: No application of CES via ear clips
Use of Sham CES for one hour per day over PR programm
Eligibility Criteria
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Inclusion Criteria
* 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
* pregnancy, lactation period
18 Years
ALL
No
Sponsors
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Schön Klinik Berchtesgadener Land
OTHER
Responsible Party
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Prof. Dr. Andreas Rembert Koczulla
Head of Pneumological Department Affiliation: Schön Klinik Berchtesgadener Land
Locations
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Klinikum Berchtesgadener Land, Schön Kliniken
Schönau am Königssee, Bavaria, Germany
Countries
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Other Identifiers
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AlphaStim
Identifier Type: -
Identifier Source: org_study_id
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