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The aim of this study is to increase parasympathetic activity and decrease the severity of symptoms by providing vagal stimulation with the t-VNS method in order to suppress the increased sympathetic activity in patients with prolonged Covid symptoms.The main question[s] it aims to answer are:
Question 1:Is left ear transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?
Question 2:Is bilateral auricular transcutaneous vagus nerve stimulation effective in suppressing the symptoms of patients in Post Covid syndrome?
A 5-minute heart rate variability measurement will be performed to measure the effectiveness of vagus nerve stimulation in participants.HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Left ear transcutaneous vagus nerve stimulation | Experimental | Left ear transcutaneous vagus nerve stimulation will be applied to the participants in this group.A continuous electrical stimulation with a current frequency of 10 Heartz (Hz) with a current transit time of 300 μs was applied to the participants in both groups. The participants included in both groups were treated with taVNS with the "Vagustim" device for 20 minutes once a day and for a total of 10 sessions application was made. |
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| Bilateral double ear transcutaneous vagus nerve stimulation | Experimental | Bilateral double ear transcutaneous vagus nerve stimulation will be applied to the participants in this group.A continuous electrical stimulation with a current frequency of 10 Heartz (Hz) with a current transit time of 300 μs was applied to the participants in both groups. The participants included in both groups were treated with taVNS with the "Vagustim" device for 20 minutes once a day and for a total of 10 sessions application was made. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Auricular transcutaneous vagus nerve stimulation | Device | Transcutaneous vagus nerve stimulation (taVNS) was performed with an FDA-approved Vagustim stimulation device and an electrode-shaped earpiece. In the participants included in the study and randomized to two groups, i) left ear taVNS was applied to the first group and ii) double-ear taVNS was applied to the second group. |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | HRV is a non-invasive method used to evaluate ANS activity and is a measure of heart rate change over a period of time. It analyzes the change in the beat-beat intervals of the heart and reflects the balance between PNS and SNS. During the analysis of heart rate variability measurement, the results obtained from sub-parameters such as stress index, time-domain and frequency-domain measurements allow evaluation of PNS and SNS activity. | After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later). |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale | The Fatigue Severity Scale, which is applied in the form of a questionnaire to determine the severity of fatigue accompanied by chronic diseases, consists of a total of 9 questions and according to the results obtained, it gives results as No Fatigue (<2.8 points) and chronic fatigue syndrome (>6.1 points). | After the evaluation of the patients on the first day of participation in the study, the final evaluation was completed at the end of the 10th session (10 days later). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramazan Erenler, Prof. Dr. | Igdir University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iğdır State Hospital | Iğdır | 76000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D001342 | Autonomic Nervous System Diseases |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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|
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009422 | Nervous System Diseases |