Persistent Pain and Its Impact on Quality of Life COVID-19 Patients That Required Critical Care

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04887220
Collaborator
(none)
30
1
27.4
1.1

Study Details

Study Description

Brief Summary

COVID-19 infection produces thousands of hospital admissions in a very short period of time, including critical care patients. It is expected that those who survive a severe spectrum of the disease, will present some degree of health decline in the medium and long term, becoming chronic patients.

Post-intensive care syndrome (PICS) was described by the Society of Critical Care Medicine (SCCM) as a new altered or worsening of physical, cognitive, or mental condition due to critical illness and persisting after hospitalization, including pain. Also, clinical features of infection include different types of pain, and if this pain persists, it can turn into a chronic condition. Chronic pain is a currently recognized disease, but under-treated in many cases, generating a significant deterioration in the quality of life of this patient. It is vitally important to generate early care circuits to detect and treat those expected complications, such as chronic pain in these patients. The objective of this study is to estimate the level of persistent pain and its impact on health-related quality of life after admission to an intensive care unit in patients who suffered this infection.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The presence of persistent pain and impaired quality of life in COVID19 patients who have required intensive care can affect up to a total of 50% of patients.

    Main objective Estimate the level of persistent pain and health-related quality of life after admission one in intensive care unit in COVID-19 patients, a new disease that has been accompanied by great health, social and economic involvement from which we do not know the long-term consequences in this patient cohort.

    Secondary goals

    • Assessing patient's characteristics before ICU admissión; the prevalence of painkillers use, including opioids, history of previous pain, and comorbidities. Find relationships between these characteristics and the development of chronic pain.

    • Determine if some ICU treatments and patient's characteristics may contribute to persistent pain in COVID-19 survivors ( number of prone therapies, thromboembolic complications, and medication for sedate used)

    • Determine the quality of life using the SF-12 test.

    • Determine pain characteristics using the ID-PAIN test.

    • Determine the scale of anxiety and depression using the HADs test.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Persistent Pain and Its Impact on Quality of Life at 3, 6 and 12 Months in COVID-19 Patients Who Have Required Critical Care
    Actual Study Start Date :
    Feb 15, 2021
    Anticipated Primary Completion Date :
    May 31, 2022
    Anticipated Study Completion Date :
    May 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. VAS scale value [1 year]

      Chronic pain in PostICU COVID19 survivors, measured by VAS scale from Brief Pain Inventory Questionnaire

    Secondary Outcome Measures

    1. Quality of life score [1 year]

      Quality of life assessment by SF-12 questionnarie, of ICU survivors after 12 months of ICU discharge

    2. ID Pain test value [1 year]

      Pain characteristics of ICU COVID 19 survivors, using ID PAIN test for presence of neuropathic pain

    3. HAD scale value [1 year]

      Level of anxiety and/or depression in post ICU survivors of COVID 19 at 12 months after discharge, using HAD questionnarie

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Post ICU COVID 19 Survivor

    • Adult 18 year or older, who gives its approval to participate

    Exclusion Criteria:
    • Refusal to participate

    • Neurological or physical secuale, disabled to answer a questionnaire

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de la Santa Creu i Sant Pau Barcelona Catalunya Spain 08025

    Sponsors and Collaborators

    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT04887220
    Other Study ID Numbers:
    • IIBSP-COV-2020-63
    First Posted:
    May 14, 2021
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2021