Pain, Fatigue and Life Quality in COVID-19 Patients

Pain Clinical Trial

Official title:

Assessment of Pain, Fatigue and Quality of Life in COVID-19 Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04988126
• Other study ID #: SAA21Covid19
• Status: Recruiting
• Start date: February 1, 2021
• Est. completion date: February 15, 2022

Study information

• Verified date: August 2021
• Source: Afyonkarahisar Health Sciences University
• Contact: Ali Izzet MD AKÇIN
• Phone: +905469347374
• Email: dr.akcin93[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 15, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Interventions
Observational study, not applicable

Locations

Country	Name	City	State
Turkey	Afyonkarahisar Health Sciences University	Afyonkarahi?sar

Sponsors (1)

Lead Sponsor	Collaborator
Afyonkarahisar Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 12th week
Secondary	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.	up to 12th week
Secondary	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.	up to 12th week
Secondary	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	up to 12th week