Pain, Fatigue and Life Quality in COVID-19 Patients
August 6, 2021 updated by: Ali İzzet Akçin, Afyonkarahisar Health Sciences University
Assessment of Pain, Fatigue and Quality of Life in COVID-19 Patients
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Anticipated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali İzzet MD AKÇİN
- Phone Number: +905469347374
- Email: dr.akcin93@gmail.com
Study Locations
-
-
-
Afyonkarahi̇sar, Turkey, 03200
- Recruiting
- Afyonkarahisar Health Sciences University
-
Contact:
- Ali İzzet MD AKÇİN
- Phone Number: +905469347374
- Email: dr.akcin93@gmail.com
-
Contact:
- Sevda MD ADAR
- Phone Number: +905325940725
- Email: drsevdaadar@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patient Group
Patient with Covid 19 Pneumonia
|
Observational study, not applicable
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: up to 12th week
|
Change from baseline visual analog scale (VAS) myalgia, arthralgia, cervical, thorocic and lumbar pain at 4th and 12th week. Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity. |
up to 12th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fatigue Severity Scale
Time Frame: up to 12th week
|
The scale evaluates the fatigue severity of the participants in the last week.
Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree.
The minimum score possible is nine and the highest is 63.
The higher the score, the more severe the fatigue is and the more it affects the person's activities.
|
up to 12th week
|
|
Hospital Anxiety And Depression Scale
Time Frame: up to 12th week
|
The Hospital Anxiety and Depression Scale (HADS) is a measure designed to assess anxiety and depression symptoms in patients.
The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.
Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
A subscore of > 7 for depression and > 10 for anxiety would indicate a clinical case.
|
up to 12th week
|
|
Short form 12 (SF-12)
Time Frame: up to 12th week
|
The SF-12 is an easy-to-administer questionnaire with proven reliability and validity, obtained by shortening and simplifying the SF-36.
It is used in the assessment of physical and mental health, the two main components of general health.
SF-12 surveys eight domains of health, such as physical functionality, physical role limitations, pain, general health, vitality, social functionality, emotional role limitations, and mental health.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning
|
up to 12th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sevda MD ADAR, Afyonkarahisar Health Sciences University
- Principal Investigator: Ali İzzet MD AKÇİN, Afyonkarahisar Health Sciences University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2021
Primary Completion (Anticipated)
October 1, 2021
Study Completion (Anticipated)
February 15, 2022
Study Registration Dates
First Submitted
July 29, 2021
First Submitted That Met QC Criteria
July 29, 2021
First Posted (Actual)
August 3, 2021
Study Record Updates
Last Update Posted (Actual)
August 12, 2021
Last Update Submitted That Met QC Criteria
August 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAA21Covid19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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