COVID-19 in Pain Perspective

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.

Study Overview

• Status: Completed
• Conditions: Pain; COVID; Infection

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 Type: Observational
• Enrollment (Actual): 466

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Sisli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In our hospital, patients who were treated with the diagnosis of COVID-19 were selected. During the selection, patients between the ages of 18-95 were selected, considering the inclusion and exclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale for Pain	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.	up to 10 weeks
Hospital Anxiety and Depression Scale (HADS)	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.	up to 10 weeks
SF-12 Health assesment Questionaire	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.	up to 10 weeks

Collaborators and Investigators

• Sponsor: Sisli Hamidiye Etfal Training and Research Hospital
• Investigators: Principal Investigator: Aylin Ayyıldız, MD, Sisli Hamidiye Etfal Training and Research Hospital

Publications and helpful links

General Publications

• Sahin T, Ayyildiz A, Gencer-Atalay K, Akgun C, Ozdemir HM, Kuran B. Pain Symptoms in COVID-19. Am J Phys Med Rehabil. 2021 Apr 1;100(4):307-312. doi: 10.1097/PHM.0000000000001699.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): June 18, 2020
• Study Completion (Actual): June 20, 2020

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): July 1, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: pain; Coronavirus; infections
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: 2811

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No