Prevention of Long Covid Syndrome

NCT ID: NCT05793736

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2023-10-30

Brief 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

Detailed 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.

Conditions

Post-Acute COVID-19 Syndrome; Biofeedback, Psychology; Quality of Life; Depressive Symptoms; Fatigue; Anxiety; Pain; Cognitive Symptom

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

biofeedback + treatment as usual

The selected sample (n 10) will undergo 10 total Biofeedback Training sessions, twice a week. Each session will last 45 minutes. The total duration of the treatment will be 5 weeks, plus standard therapies (treatment as usual)

Group Type: EXPERIMENTAL

Biofeedback training

Intervention Type: DEVICE

The intervention lasts 5 weeks, twice a week, each session lasts 45 minutes in which HRV (Heart Rate Variability) is detected, through plethysmographic sensors placed on the finger or earlobe during assigned tasks. During tasks that involve progressively more complex phases, they allow the person to receive immediate feedback on the video screen.

treatment as usual

The control sample (n 10) will be treated only with standard therapies (treatment as usual) without the use of biofeedback training

Group Type: ACTIVE_COMPARATOR

Treatment as usual

Intervention Type: DRUG

The sample will be treated only with standard therapies (treatment as usual) without the use of biofeedback training

Interventions

Biofeedback training

The intervention lasts 5 weeks, twice a week, each session lasts 45 minutes in which HRV (Heart Rate Variability) is detected, through plethysmographic sensors placed on the finger or earlobe during assigned tasks. During tasks that involve progressively more complex phases, they allow the person to receive immediate feedback on the video screen.

Intervention Type: DEVICE

Treatment as usual

The sample will be treated only with standard therapies (treatment as usual) without the use of biofeedback training

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• People who have contracted Covid-19 and have symptoms attributable to Long syndrome

Exclusion Criteria

• patients with cognitive difficulties and/or diagnosis of mental retardation
• patients with severe comorbidities with the exception of anxious/depression symptoms arising in conjunction with the viral infection or long covid syndrome.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Giulia Cossu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

P.O. San Giovanni di Dio, AOU Cagliari

Cagliari, , Italy

Countries

Italy

Other Identifiers

NP/2023/496

Identifier Type: -

Identifier Source: org_study_id