Clinical trial NCT04454333: COVID-19 in Pain Perspective
Official title: COVID-19 in Pain Perspective
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
COVID
Pain
Keywords: infections
pain
Coronavirus
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Numeric Rating Scale for Pain
timeFrame: up to 10 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: up to 10 weeks
measure: SF-12 Health assesment Questionaire
timeFrame: up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Şişli Hamidiye Etfal Training and Research Hospital
name: Aylin Ayyıldız, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.