Clinical trial NCT04988126: Pain, Fatigue and Life Quality in COVID-19 Patients
Official title: Assessment of Pain, Fatigue and Quality of Life in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Pain
Fatigue
Quality of Life
Keywords: COVID-19 Pneumonia
Pain
Fatigue
Quality of Life
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who are hospitalized in the Pandemic Service, and are positive for COVID-19 PCR

Brief summary: The aim in this study is to evaluate pain, fatigue and quality of life in patients with Covid-19 pneumonia in long-term follow-up and to investigate their relationship with pneumonia severity, age, presence of comorbidity and depression level.

Detailed description: Patients over the age of 18 who are hospitalized in the Pandemic Service, and are positive for COVID-19 PCR, will be included in the study if the participants read the informed consent form and volunteer for the study.

Patients' age, comorbidities, initial symptoms, and pneumonia severity (mild/moderate/severe) will be recorded. Pain, fatigue and depression assessments will be made on the first day of hospitalization, at discharge, at the 1st month and 3rd month after discharge. The 1st and 3rd month evaluations of the patients will be made by contacting the participants by phone. In addition to the 1st and 3rd month evaluations, the quality of life will also be evaluated with the SF-12 questionnaire.

Eligibility criteria: Inclusion Criteria: Patients over the age of 18 who are hospitalized in the Pandemic Service, and are positive for COVID-19 PCR, will be included in our study.

* Patient with Covid 19 Pneumonia

Exclusion Criteria:

* Uncooperative Patient,
* Illiterate Patients,
* Pregnancy,
* Patients with Chronic Pain or Fatigue in the last 6 months (before COVID-19 disease),
* Patients who were admitted to the intensive care unit during their hospitalization

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: up to 12th week
Secondary outcomes:
measure: Fatigue Severity Scale
timeFrame: up to 12th week
measure: Hospital Anxiety And Depression Scale
timeFrame: up to 12th week
measure: Short form 12 (SF-12)
timeFrame: up to 12th week
Other outcomes:
Locations:
city: Afyonkarahi̇sar
country: Turkey
facility: Afyonkarahisar Health Sciences University
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Sevda MD ADAR
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: Ali İzzet MD AKÇİN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cipollaro L, Giordano L, Padulo J, Oliva F, Maffulli N. Musculoskeletal symptoms in SARS-CoV-2 (COVID-19) patients. J Orthop Surg Res. 2020 May 18;15(1):178. doi: 10.1186/s13018-020-01702-w. No abstract available.
citation: Garrigues E, Janvier P, Kherabi Y, Le Bot A, Hamon A, Gouze H, Doucet L, Berkani S, Oliosi E, Mallart E, Corre F, Zarrouk V, Moyer JD, Galy A, Honsel V, Fantin B, Nguyen Y. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020 Dec;81(6):e4-e6. doi: 10.1016/j.jinf.2020.08.029. Epub 2020 Aug 25.
citation: Halpin SJ, McIvor C, Whyatt G, Adams A, Harvey O, McLean L, Walshaw C, Kemp S, Corrado J, Singh R, Collins T, O'Connor RJ, Sivan M. Postdischarge symptoms and rehabilitation needs in survivors of COVID-19 infection: A cross-sectional evaluation. J Med Virol. 2021 Feb;93(2):1013-1022. doi: 10.1002/jmv.26368. Epub 2020 Aug 17.