Chronic fatigue, quality of life, and pain in patients with persistent COVID-19. Infections and Infestations
Conditions
Interventions
As for the ozone protocol, 8 mg of medical ozone (200 ml of gas at a concentration of 40 µg/ml) will be administered per session. The complete protocol will consist of 24 sessions of rectal ozone ther
Sponsors
Universidad Católica de Murcia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 70 years old with a confirmed diagnosis of persistent COVID 2. Positive swab test for SARS-CoV2 infection 3. Patients who sign an informed consent form to participate in the study 4. Patients capable of understanding and performing the tasks for the proposed tests 5. Patients who are able to participate in the study for a period of 12 weeks
Exclusion criteria
Exclusion criteria: 1. Patients suffering from any psychiatric disorder specified in axis I of the DSM-V other than major depression 2. Patients with a history or current history of substance abuse. Those patients with a history of substance use will be admitted if they have been abstinent for at least one year 3. Patients with a history or current history of substance abuse. Those patients with a history of substance abuse will be admitted if they have been abstinent for at least one year 4. Patients who are unable to clearly understand the objectives and methodology of the study 5. Pregnant or breastfeeding women 6. Patients with hyperthyroidism 7. Pregnant or breastfeeding women 8. Patients with hyperthyroidism 9. Patients with favism 10. Subjects who report in advance that they will be unable to attend all the required ozone therapy sessions 11. Patients who have been treated with medical ozone in the 9 months prior to the start of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following primary outcome measures are assessed throughout the study at the beginning of each week: 1. Functional limitations when subjects carry out their tasks and activities of daily living, as well as changes in their lifestyles, are measured using the Post-COVID-19 Functional Status Scale (PCFS) 2. Incapacitating fatigue is measured using the Fatigue Severity Scale (FSS) 3. Cognitive screening is measured using the Montreal Cognitive Assessment Test (MoCA) 4. The intensity of pain (sensory dimension), as well as the interference of pain in the patient's life (reactive dimension), is measured using the Brief Pain Inventory (BPI) 5. Headache impact is measured using the Headache Impact Test (HIT-6) 6. Overall health status in terms of physical, social, and emotional aspects, vitality, and pain is measured using the Short-Form Health Survey (SF-12) 7. Hand grip strength is measured using the Handgrip Strength Test (HST) 8. The overall clinical impression of disease severity is measured with Patient Clinical Global Impression Severity (PGIs) 9. The overall clinical impression of improvement, as assessed by the patient, is measured with Patient Clinical Global Impression Improvement (PGIi) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed throughout the study at the beginning of each week: 1. Depression is measured using the Beck Depression Inventory Second Edition (BDI-II) 2. The presence and severity of anxiety, as well as the individual's propensity to suffer from it, are measured using the State-Trait Anxiety Inventory (STAI) 3. Sleep Quality is measured using the Pittsburgh Sleep Quality Inventory (PSQI) | — |
Countries
Spain
Contacts
Public ContactAlessio Cabizosu
Outcome results
None listed