- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04753463
Assessment of the Impact of COVID-19 Pandemic on Residents Training and Mental Health in Poland
Study Overview
Detailed Description
The novel coronavirus SARS-CoV-2, responsible for Coronavirus Disease 2019 (COVID-19), was first identified at the end of the year 2019 in Wuhan (China). A rapid spread of the disease resulted in global threat to public health. On 11 March 2020 the World Health Organization (WHO) announced the state of pandemic. In Poland, the first confirmed case of COVID-19 was reported on 4 March 2020 and subsequent growing number of patients has placed tremendous strain on healthcare system. The crisis situation prompted immediate action to divert healthcare resources for the treatment of patients with COVID-19 and to limit the spread of the infection. In accordance with the decision of the Minister of Health of March 13th, 2020, more than twenty hospitals were established to admit only the SARS-CoV-2 affected patients. Moreover, all hospitals were recommended to limit their planned activity and to perform only urgent and emergency services.
The investigators hypothesize that those changes in healthcare system and restrictions established in public area during pandemic caused significant difficulties in residency training considering clinical and surgical practice as well as didactic activities. In spite of gradual reopening the routine services over the last few months, social distancing rules are still in force. Accordingly, different methods of virtual teaching were introduced including, inter alia, organisation of courses, lectures and conferences in form of on-line meetings.
The aim of current study is to investigate the impact of SARS-CoV-2 on ophthalmology training programs among residents. To the best of our knowledge this study is the first of its kind in Poland. The impact of COVID-19 on ophthalmology training programs is largely unknown as there are only few studies assessing the above issue from the resident's point of view.
The investigators believe that this investigations will address this gap in the literature and could be used to initiate the new solutions in order to maintain successful residency training during pandemic. Opinions regarding the efficiency of e-learning methods and on-line meetings may be crucial to innovate the conventional teaching way permanently in the future.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Białystok, Poland, 15-089
- Medical University
-
Białystok, Poland, 15-089
- Ophthalmology Clinic Medical University of Bialystok
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- male and female in the age of 25-35 during residence training
Exclusion Criteria:
- lack of consent for participating in survey
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Residents of Ophthalmology working on COVID-19 departments
Residents of ophthalmology working on COVID-19 departments and dealing with SARS-CoV-2 positive patients
|
The on-line questionnaire which assess the subjective feelings of residents of pandemic impact on ophthalmology training programs
|
|
Residents of Ophthalmology working on general ophthalmic departments
Residents of Ophthalmology working on general ophthalmic departments and not dealing with SARS-CoV-2 positive patients
|
The on-line questionnaire which assess the subjective feelings of residents of pandemic impact on ophthalmology training programs
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
questionnaire assessing the incidence of disturbance of COVID-19 pandemic on ophthalmology training programs among residents
Time Frame: 1 month
|
the opinion of ophthalmology training programs among residents assessed with the questionnaire collecting demographics (age, gender), domicile (state, union territory), current professional status (in training or practising), type of practice (solo, group, institutional, governmental, non-governmental), marital status (married, single), impact of COVID-19 on their training or ophthalmology practice, and impact on income and ability to meet living expense
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
questionnaire assessing the negative impact of COVID-19 pandemic on mental health among ophthalmology residents
Time Frame: 1 month
|
the opinion on impact for mental health among residents assessed with the Patient Health Questionnaire-9 (PHQ-9).
PHQ-9 is a selfreport measure that is used to assess the severity of depression over the prior 2 weeks.
Response to the nine questions are graded as 0 (not at all), 1 (several days), 2 (more than half the days), and 3 (nearly every day).
The total score of PHQ-9 that categorizes depression is as follows: minimal/no depression (0-4), mild depression (5-9), moderate depression (10-14), or severe depression (15-21).
|
1 month
|
|
questionnaire assessing the attitude on COVID-19 vaccination of ophthalmology residents
Time Frame: 1 month
|
the attitude towards the vaccination against the SARS-CoV-2 among residents assessed with the questionnaire with open questions about the willingness of taking the vaccination
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Marek MD Rękas, Prof, Wojskowy Instytut Medyczny
Publications and helpful links
General Publications
- Silva N, Laiginhas R, Meireles A, Barbosa Breda J. Impact of the COVID-19 Pandemic on Ophthalmology Residency Training in Portugal. Acta Med Port. 2020 Oct 1;33(10):640-648. doi: 10.20344/amp.14341. Epub 2020 Sep 10.
- Mishra D, Nair AG, Gandhi RA, Gogate PJ, Mathur S, Bhushan P, Srivastav T, Singh H, Sinha BP, Singh MK. The impact of COVID-19 related lockdown on ophthalmology training programs in India - Outcomes of a survey. Indian J Ophthalmol. 2020 Jun;68(6):999-1004. doi: 10.4103/ijo.IJO_1067_20.
- El-Saied HMA, Salah Eddin Abdelhakim MA. Impact of COVID-19 Pandemic on Young Ophthalmologists in Cairo University Hospitals. Semin Ophthalmol. 2020 Aug 17;35(5-6):296-306. doi: 10.1080/08820538.2020.1826046. Epub 2020 Oct 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1775
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on SARS-CoV-2
-
AIM Vaccine Co., Ltd.Zhejiang Provincial Center for Disease Control and PreventionNot yet recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Not yet recruiting
-
University Hospital, Montpelliersociete SkillCell - 97198 Jarry; CNRS Alcediag UMR9005 - societe Sys2Diag -...Completed
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical CollegeActive, not recruiting
-
AIM Vaccine Co., Ltd.Hunan Provincial Center for Disease Control and PreventionCompleted
-
Indiana UniversityCompletedSARS-CoV-2United States
-
Peking UniversityCenters for Disease Control and Prevention, China; Beijing Pinggu District... and other collaboratorsCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Generate BiomedicinesCompleted
-
Arcturus Therapeutics, Inc.Terminated
Clinical Trials on Survey
-
Johns Hopkins Bloomberg School of Public HealthPontificia Universidad JaverianaCompletedNoncommunicable Diseases | Surveys and QuestionnairesColombia
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedSarcoma | Breast Carcinoma | Head and Neck CarcinomaUnited States
-
Weill Medical College of Cornell UniversityBoston Children's Hospital; Brigham and Women's Hospital; The Commonwealth FundCompletedPediatric ALLUnited States
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Université de Cergy PontoiseCompleted
-
Sarasota Memorial Health Care SystemEnrolling by invitation
-
Ohio State UniversityWithdrawnMedicare Part DUnited States
-
Johns Hopkins Bloomberg School of Public HealthIfakara Health InstituteCompletedNoncommunicable Diseases | Surveys and QuestionnairesTanzania
-
Memorial Sloan Kettering Cancer CenterCompletedInpatients With Limited English ProficiencyUnited States
-
Lawson Health Research InstituteCompletedEvaluation of an Introductory Videotape Intervention to Improve Cardiac Rehabilitation ParticipationMyocardial Infarction | Unstable Angina | Coronary Angioplasty | Coronary Artery Bypass SurgeryCanada