Pain, Fatigue and Life Quality in COVID-19 Patients

Sponsor
Afyonkarahisar Health Sciences University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04988126
Collaborator
(none)
150
1
12.5
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interventions

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

Study Type:
Observational
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessment of Pain, Fatigue and Quality of Life in COVID-19 Patients
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Feb 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Patient Group

Patient with Covid 19 Pneumonia

Other: Interventions
Observational study, not applicable

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale (VAS) [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.

Secondary Outcome Measures

  1. Fatigue Severity Scale [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.

  2. Hospital Anxiety And Depression Scale [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.

  3. Short form 12 (SF-12) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Afyonkarahisar Health Sciences University Afyonkarahi̇sar Turkey 03200

Sponsors and Collaborators

  • Afyonkarahisar Health Sciences University

Investigators

  • Principal Investigator: Sevda MD ADAR, Afyonkarahisar Health Sciences University
  • Principal Investigator: Ali İzzet MD AKÇİN, Afyonkarahisar Health Sciences University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali İzzet Akçin, Research Assistant-MD, Afyonkarahisar Health Sciences University
ClinicalTrials.gov Identifier:
NCT04988126
Other Study ID Numbers:
  • SAA21Covid19
First Posted:
Aug 3, 2021
Last Update Posted:
Aug 12, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ali İzzet Akçin, Research Assistant-MD, Afyonkarahisar Health Sciences University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2021