Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19
- Conditions
- POST-Covid 19Anxiety
- Interventions
- Device: Application of CES via ear clips
- Registration Number
- NCT05126511
- Lead Sponsor
- Schön Klinik Berchtesgadener Land
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
- acitve implants (cardiac pacemaker,...)
- pregnancy, lactation period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Post-Covid patients, non anxious, functional device Application of CES via ear clips Application of 100µA CES for one hour per day to non anxious patients Post-Covid patients, anxious, functional device Application of CES via ear clips Applitation of 100µA CES for one hour per day to anxious patients
- Primary Outcome Measures
Name Time Method Change of symptoms of anxiety during intervention Day 1 and Day 21 Comparison of the Beck Anxiety Inventory pre and post pulmonary rehabilitation
- Secondary Outcome Measures
Name Time Method Subjective effectiveness of device Day 21 Evaluation of the diary kept by the patient
Change in insomnia during intervention Day 1 and Day 21 Comparison of the PSQI questionnaire pre and post pulmonary rehabilitation
Change in fatigue during intervention Day 1 and Day 21 Comparison of the FAS questionnaire pre and post pulmonary rehabilitation
Change of general condition/ perceived well-being of the patient Day 1 until 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 in depression during intervention Day 1 and Day 21 Comparison of the PHQ-9 questionnaire pre and post pulmonary rehabilitation
Trial Locations
- Locations (1)
Klinikum Berchtesgadener Land, Schön Kliniken
🇩🇪Schönau Am Königssee, Bavaria, Germany