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Status unknownNCT04988126Updated Aug 12, 2021

Pain, Fatigue and Life Quality in COVID-19 Patients

An observational study in COVID-19 Pneumonia, Pain and Fatigue, sponsored by Afyonkarahisar Health Sciences University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-12.

Sponsored by Afyonkarahisar Health Sciences University · Observational

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID-19 Pneumonia
  • Pain
  • Fatigue
  • Quality of Life

Keywords

  • COVID-19 Pneumonia
  • Pain
  • Fatigue
  • Quality of Life
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 150 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Afyonkarahisar Health Sciences University is the lead sponsor of 107 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient Group

    Patient with Covid 19 Pneumonia

    Other: Interventions

Interventions

  • OtherInterventions

    Observational study, not applicable

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale (VAS)

    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.

    Time frame: up to 12th week

Secondary outcomes

  1. Fatigue Severity Scale

    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.

    Time frame: up to 12th week

  2. Hospital Anxiety And Depression Scale

    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.

    Time frame: up to 12th week

  3. Short form 12 (SF-12)

    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

    Time frame: up to 12th week

07

Study locations

1 of 1 sites recruiting
  • Afyonkarahisar Health Sciences University
    Afyonkarahi̇sar, 03200, Turkey
    Recruiting
08

References and documents

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. No abstract available. PubMed 32423471 ↗
  • 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. PubMed 32853602 ↗
  • 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. PubMed 32729939 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04988126
Lead sponsor
Afyonkarahisar Health Sciences University
Responsible party
Ali İzzet Akçin (Research Assistant-MD, Afyonkarahisar Health Sciences University) — Principal investigator
First posted
Aug 3, 2021
Start date
Feb 1, 2021
Primary completion
Oct 1, 2021 (estimated)
Completion
Feb 15, 2022 (estimated)
Last update
Aug 12, 2021

Study contacts

Ali İzzet MD AKÇİN
Contact
dr.akcin93@gmail.com
+905469347374
Sevda MD ADAR
principal investigator · Afyonkarahisar Health Sciences University
Ali İzzet MD AKÇİN
principal investigator · Afyonkarahisar Health Sciences University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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