Clinical trial NCT05126511: Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19
Official title: Effects of Cranial Electrotherapy Stimulation on Anxiety of Patients After COVID-19 - a Randomised Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: POST-Covid 19
Anxiety
Keywords: Long-Covid/ Post-Covid
CES
fatigue
insomnia
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change of symptoms of anxiety during intervention
timeFrame: Day 1 and Day 21
Secondary outcomes:
measure: Change in insomnia during intervention
timeFrame: Day 1 and Day 21
measure: Change in fatigue during intervention
timeFrame: Day 1 and Day 21
measure: Change in depression during intervention
timeFrame: Day 1 and Day 21
measure: Change of general condition/ perceived well-being of the patient
timeFrame: Day 1 until Day 21
measure: Subjective effectiveness of device
timeFrame: Day 21
measure: Comfort while using the device
timeFrame: Day 21
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Klinikum Berchtesgadener Land, Schön Kliniken
state: Bavaria
Study officials:
References: