Clinical Trials Logo

Clinical Trial Summary

Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management in post-Covid-19 syndrome. The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with long covid, and also to verify improvement induced by the technique in relation to: cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms


Clinical Trial Description

Long COVID is known by different names, and include a wide range of persistent symptoms that develop after SARS-CoV-2 infection and last for usually more than 12 weeks to months and up to 2 years, so far. The most common symptoms categorizable as neurological are fatigue, brain fog, and headache, among respiratory symptoms chest pain and shortness of breath, other less easily classifiable symptoms are heart palpitations and muscle pain. These symptoms are often debilitating enough to leave patients unable to work. According to the WHO (2023), an estimated 17 million people were thought to be living with the long-term effects of COVID-19. Still now in less active pandemic phases, the risk of developing long COVID symptoms, at 10-20% of those infected, remains just as strong. Trying to find a solution to manage symptoms through evidence-based practices is considered a current necessity to help health patients and professionals. Biofeedback allows to learn self-regulation of some physiological processes through feedback of recorded parameters and the goal is improving health and its performances. Biofeedback measures muscle activity, skin temperature, electrodermal activity (sudoriparous glands activity), respiration, heart rate, blood pressure, electrical brain activity and bloodstream, it also gives a quick feedback of those personal measurements to the patient, in this way biofeedback teaches people to have a more active role in maintaining a good personal, mental and physical health (quickly and thoroughly it give person feedback of activity and biofeedback teaches people to take a more active role in maintaining personal health and mental health and physical health). Biofeedback equipment is classified by the Food and Drug Administration (FDA) as medical device class II and this type of equipment/treatment has shown evidence regarding stress management (evidence were shown as regards stress menagement). The greatest benefits from using biofeedback are: improvement of sleep quality, improvement of self- efficacy, improvement of pain threshold, and improvement of emotional adjustment. In particular, a study conducted with HRV biofeedback, in which the sample learned resonance frequency breathing, showed dicreases in depression and pain and improved the person's system functioning. Study objectives The main objective of the study is to verify the feasibility of an HVR biofeedback training protocol in patients with Long Covid syndrome, and also to produce a preliminary measurement of the possible improvement induced by the technique in relation to:cognitive performance; pain perception; fatigue; quality of life; depressive and anxious symptoms. This measure will be useful to estimate the expected improvement in future case-control studies. Study design This is a controlled clinical trial between usual care and biofeedback training plus usual care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05793736
Study type Interventional
Source University of Cagliari
Contact
Status Completed
Phase N/A
Start date February 2, 2023
Completion date October 30, 2023

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care