COVID-19 in Pain Perspective

Pain Clinical Trial

Official title:

COVID-19 in Pain Perspective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454333
• Other study ID #: 2811
• Status: Completed
• Start date: June 3, 2020
• Est. completion date: June 20, 2020

Study information

• Verified date: June 2020
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 466
• Est. completion date: June 20, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID
• Infection
• Pain

Locations

Country	Name	City	State
Turkey	Sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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