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Prevention of Long Covid Syndrome

NCT05793736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-05-13

No results posted yet for this study

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

Conditions

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

Interventions

DEVICE

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.

DRUG

Treatment as usual

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

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2023-10-30
Completion
2023-10-30
FDA Device
Yes

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793736 on ClinicalTrials.gov