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COVID-19 in Pain Perspective

Sponsor
Sisli Hamidiye Etfal Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04454333
Collaborator
(none)
466
Enrollment
1
Location
17
Actual Duration (Days)
834.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In our hospital's Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain status of the patients after treatment.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This retrospectively designed study was carried out by analyzing SARS-CoV-2 infected and hospitalized patients in our hospital for 2 month. The patients, whose contact information can be accessed from the hospital records, will be called by phone and pain inquiries were made during the SARS-CoV-2 infection process. In addition, patients' demographic data, living conditions (number and characteristics of the person in the household), comorbidities, symptom inquiry related to infection, duration of symptoms, length of hospitalstay, pre-infection pain conditions and current pain, anxiety, depression levels and quality of life will be questioned.

    The pain questioning include the painful body region/s, severity (Numeric Rating Scale), type of analgesic drugs used, and duration of use that occurred during infection. Anxiety and depression levels will be evaluated, hospital anxiety and depression scale (HADS), and quality of life will be evaluated with SF-12 health assessment questionnaire.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    466 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    COVID-19 in Pain Perspective
    Actual Study Start Date :
    Jun 3, 2020
    Actual Primary Completion Date :
    Jun 18, 2020
    Actual Study Completion Date :
    Jun 20, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Hospitalized caused by COVID-19

    A total of 466 patients hospitalized with the diagnosis of SARS-COV-2 at the University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital were retrospectively screened. 212 of these patients did not answer the calls, 34 of them could not be reached because they gave the wrong phone number beforehand. 4 of the patients called by the phone had communication problems due to language problems and 10 people did not want to fill the questionnaire. 206 of them were contacted by the phone and their pain and myalgia in the head, neck-back, waist, shoulder and hip regions before, during and after SARS-COV-2, their anxiety and depression levels after SARS-COV-2, and their quality of life were questioned.

    Outcome Measures

    Primary Outcome Measures

    1. Numeric Rating Scale for Pain [up to 10 weeks]

      Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome.

    2. Hospital Anxiety and Depression Scale (HADS) [up to 10 weeks]

      Evaluation of patient's anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome.

    3. SF-12 Health assesment Questionaire [up to 10 weeks]

      Evaluation of patient's quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with positive PCR test results obtained from combined throat and nasopharyngeal swab samples

    • patients consistent with Covid-19 infection as a result of thorax computed tomography, although PCR test results were negative.

    Exclusion Criteria:

    • Patients who have undergone surgery and trauma in the painful area in the past 3 months,

    • Patients with pathological disease that can cause underlying pain

    • Pregnant women

    • Those who have psychiatric illness and use psychiatric drugs

    • Presence of malignancy

    • Patients with severe cognitive deficits

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Şişli Hamidiye Etfal Training and Research Hospital Istanbul Turkey

    Sponsors and Collaborators

    • Sisli Hamidiye Etfal Training and Research Hospital

    Investigators

    • Principal Investigator: Aylin Ayyıldız, MD, Şişli Hamidiye Etfal Training and Research Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aylin Ayyıldız, Medical Doctor, Sisli Hamidiye Etfal Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04454333
    Other Study ID Numbers:
    • 2811
    First Posted:
    Jul 1, 2020
    Last Update Posted:
    Jul 1, 2020
    Last Verified:
    Jun 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aylin Ayyıldız, Medical Doctor, Sisli Hamidiye Etfal Training and Research Hospital
    infections
    pain
    Coronavirus
    Additional relevant MeSH terms:
    Infections

    Study Results

    No Results Posted as of Jul 1, 2020