COVID-19 PneumoniaNCT04988126
Pain, Fatigue and Life Quality in COVID-19 Patients
An observational study of COVID-19 Pneumonia and Pain, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19 Pneumonia, Pain, Fatigue
- What is being tested?
- Interventions
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 15 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over the age of 18 who are hospitalized in the Pandemic Service, and are positive for COVID-19 PCR
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03200
Ali İzzet MD AKÇİN, +905469347374, dr.akcin93@gmail.com
Sevda MD ADAR, +905325940725, drsevdaadar@gmail.com
About this study
Official title: 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.
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.
- Conditions
- COVID-19 Pneumonia, Pain, Fatigue, Quality of Life
- Being tested
- Interventions
- Keywords
- COVID-19 Pneumonia, Pain, Fatigue, Quality of Life
- Medical subject headings
- Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionsOther
Observational study, not applicable
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Patient with Covid 19 Pneumonia Receives: Other: Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12th week
Secondary outcomes (3)
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.
Measured: up to 12th week
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.
Measured: up to 12th week
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
Measured: up to 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Feb 2021
- Primary completion1 Oct 2021 (estimated)
- Study completion15 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali İzzet Akçin, Afyonkarahisar Health Sciences University
- Investigators
- Sevda MD ADAR, Principal investigator, Afyonkarahisar Health Sciences UniversityAli İzzet MD AKÇİN, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988126
- Sponsor's protocol ID
- SAA21Covid19
- Status last verified
- Aug 2021
- First submitted
- 29 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32423471Garrigues 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 32853602Halpin 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pain, Fatigue and Quality of Life in COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04988126
- Acronym / sponsor ID
- SAA21Covid19
- Conditions
- COVID-19 Pneumonia, Pain, Fatigue, Quality of Life
- Keywords
- COVID-19 Pneumonia, Pain, Fatigue, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 15 Feb 2022 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Other: InterventionsPatient with Covid 19 Pneumonia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over the age of 18 who are hospitalized in the Pandemic Service, and are positive for COVID-19 PCR
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionsObservational study, not applicable | Other | Patient Group |
Primary outcome
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.
3 secondary outcomes
Fatigue Severity Scale
Time frame: up to 12th week
Hospital Anxiety And Depression Scale
Time frame: up to 12th week
Short form 12 (SF-12)
Time frame: up to 12th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Background: PubMed 32423471Cipollaro 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.
- Background: PubMed 32853602Garrigues 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.
- Background: PubMed 32729939Halpin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevda MD ADAR principal investigator
Afyonkarahisar Health Sciences University
Ali İzzet MD AKÇİN principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pneumonia and Pain, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali İzzet MD AKÇİN (+905469347374, dr.akcin93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: up to 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988126, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.