Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04698044 |
| Other study ID # |
COVFAIROFALL |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 8, 2020 |
| Est. completion date |
June 25, 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The COVID-19 pandemic has negatively affected individuals not only physiologically but also
psychologically. The aim of this study is to examine the anxiety and depression status of
cancer patients, individuals with non-cancer chronic diseases and healthy individuals with an
online screening questionnaire during the COVID-19 pandemic period.
Description:
Our aim is to evaluate and compare the anxiety and depression status of cancer patients,
individuals with non-chronic chronic diseases and healthy individuals during the COVID-19
period with an online screening program.
A simple random sampling method performed by a computer was used in selecting the
participants from 7,000 people whose information was available in the hospital automation
system. The computer program enumerates the items in the sampling frame, determines its own
random numbers, and presents the selected items to the researcher in writing or digitally
(Newman & Ridenour, 1998).
The sample groups were randomly selected from cancer patients, patients with non-cancer
chronic diseases and those without any diseases. The study included individuals who were aged
18 years and above, volunteered to participate in the study and were literate. The diagnoses
recorded in the electronic medical records of the patients were examined, and those diagnosed
with psychiatric diseases (depression, mania, bipolar disorder, psychosis,
obsessive-compulsive disorder, etc.), mental retardation, dementia, and Alzheimer's disease
were excluded. In addition, the questionnaire questions include the question of the presence
of existing psychiatric and neurological diseases. The patient was excluded from the study
also if these diagnoses were reported by the patient. Moreover, the participation of the
patient in the study was not allowed in the presence of both cancer and a non-cancer chronic
disease. Non-cancer chronic diseases were defined as diabetes mellitus, hypertension,
neurological diseases, asthma, chronic obstructive pulmonary disease (COPD), other pulmonary
diseases, cardiovascular diseases, and hypothyroidism. Other patients who used chronic
medication and/or were followed up for any chronic disease (rheumatic disease, endocrinal
disorders, liver disease, kidney diseases) were classified as other chronic diseases.
Approval was taken from the University of Health Sciences, XXX Ethics Committee (approval
number: 20/133) before the study commenced. The patients were called with phone and confirmed
whether they wanted to participate in the study, and their consents were obtained.
Individuals who wanted to participate in the study was informed about the purpose of the
study, procedure and data privacy, and told that participation was on a voluntary basis, and
individuals could leave the research at any time they wanted. Individuals read and signed
their consent forms online. The study was conducted in compliance with the "Ethical
principles for medical research involving human subjects" of the Helsinki Declaration. All
data were collected with Survey Monkey (2005 SurveyMonkey.com), which provides electronic
self-control, prevents multiple entries from the same person, and makes it easier to collect
and track data (last data entry: 07/06/2020). Confidentiality was guaranteed by completely
deactivating electronic records and IP address records.
