NCT04791085

Brief Summary

A new pandemic appeared in early 2020, also known as the coronavirus (Covid-19), affecting all health systems worldwide. Medical and nursing staff make every effort to treat patients resulting in physical and psychological exhaustion, which is exacerbated by the lack of medical and nursing staff, the lack of protective equipment, the increased workload, and increased shifts. In this context, the surgeons had to contribute in turn, in order to help as much as they could in dealing with this new health crisis, as a result of which they find themselves in positions that are not on their subject or in their proper training and to handle patients with a dangerous and highly aggressive respiratory infection. This brought more psychological and physical stress to the surgeons. The pandemic of Covid-19 is not known to be a purely surgical condition, but many patients with coronavirus require surgery due to an additional infection, condition, or complication. The design of this research will be observational and quantitative. Quantitative design involves the provision of numerically coded and analytical measurements, such as self-report questionnaires. The purpose of this cross-sectional research is primarily to record the levels of stress, anxiety, depressive symptoms of Greek surgeons, and their lifestyle. Secondary to correlate the stress levels with socio-demographic data and their lifestyle with other parameters of the study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 8, 2021

Last Update Submit

March 9, 2021

Conditions

Outcome Measures

Primary Outcomes (6)

  • Perceived Stress Scale (PSS)

    most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress.PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.

    day 1

  • DASS-21

    The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. Scores for depression, anxiety and stress are calculated by summing the scores for the relevant items.Recommended cut-off scores for conventional severity labels (normal, moderate, severe) are as follows:Depression normal 0-9, mild 10-13, moderate 14-20, severe 21-27, extremely severe 28+, Anxiety normal 0-7, mild 8-9, moderate 10-14, severe 15-19, extremely severe 20+, Stress normal 0-14, mild 15-18, moderate 19-25, severe 26-33, extremely severe 34+

    day 1

  • PITTSBURGH (GR-PSQI)

    The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21. A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.

    day 1

  • Healthy Lifestyle and Personal Control Questionnaire

    the Healthy Lifestyle and Personal Control Questionnaire (HLPCQ),which aims to assess the concept of empowerment through a constellation of daily activities.1) Dietary Healthy Choices, 2) Dietary Harm Avoidance, 3) Daily Routine, 4) Organized Physical Exercise and 5) Social and Mental Balance. All subscales showed satisfactory internal consistency and variance, relative to theoretical score ranges. Subscale scores and the total score were significantly correlated with perceived stress and health locus of control, implying good criterion validity. Associations with sociodemographic data and other variables, such as sleep quality and health assessments, were also found.The HLPCQ is a good tool for assessing the efficacy of future health-promoting interventions to improve individuals' lifestyle and wellbeing.

    day 1

  • Multi dimensional Health Locus of Control (MHLC)

    The health control center will be evaluated using the Multi dimensional Health Locus of Control (MHLC). The MHLC consists of three sub-scales that assess whether the respondent attributes the outcome of his or her health events to luck, to himself or to others. This questionnaire consists of a total of 18 questions with possible answers from ("I strongly disagree") to 6 ("I strongly agree"). For each sub-scale, high values mean strong performance on this factor.

    day 1

  • COVID-19-Anxiety Questionnaire (C-19-A)

    Participants' concerns about covid-19 will be measured using the COVID-19-Anxiety Questionnaire (C-19-A). This measurement tool consists of 10 questions that are scored on a Likert scale with values from 0 (not at all) to 4 (too much). High prices reflect high concern.

    day 1

Study Arms (1)

general surgeons

General surgeons who work at general or private hospitals in Greece

Eligibility Criteria

Age23 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Greek general surgeons and interns of general surgery working in private and general hospitals in the country.

You may qualify if:

  • participants will be surgeons or interns of general surgery in any hospital in Greece.

You may not qualify if:

  • participants who will practice another medical specialty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sismanoglio-Amalia Fleming Hospital

Athens, Melissia, 15127, Greece

RECRUITING

Related Publications (7)

  • Nickell LA, Crighton EJ, Tracy CS, Al-Enazy H, Bolaji Y, Hanjrah S, Hussain A, Makhlouf S, Upshur RE. Psychosocial effects of SARS on hospital staff: survey of a large tertiary care institution. CMAJ. 2004 Mar 2;170(5):793-8. doi: 10.1503/cmaj.1031077.

    PMID: 14993174BACKGROUND
  • Chan AO, Huak CY. Psychological impact of the 2003 severe acute respiratory syndrome outbreak on health care workers in a medium size regional general hospital in Singapore. Occup Med (Lond). 2004 May;54(3):190-6. doi: 10.1093/occmed/kqh027.

    PMID: 15133143BACKGROUND
  • Rossi R, Socci V, Pacitti F, Di Lorenzo G, Di Marco A, Siracusano A, Rossi A. Mental Health Outcomes Among Frontline and Second-Line Health Care Workers During the Coronavirus Disease 2019 (COVID-19) Pandemic in Italy. JAMA Netw Open. 2020 May 1;3(5):e2010185. doi: 10.1001/jamanetworkopen.2020.10185.

    PMID: 32463467BACKGROUND
  • Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

    PMID: 32202646BACKGROUND
  • Shanafelt T, Ripp J, Trockel M. Understanding and Addressing Sources of Anxiety Among Health Care Professionals During the COVID-19 Pandemic. JAMA. 2020 Jun 2;323(21):2133-2134. doi: 10.1001/jama.2020.5893. No abstract available.

    PMID: 32259193BACKGROUND
  • Balibrea JM, Badia JM, Rubio Perez I, Martin Antona E, Alvarez Pena E, Garcia Botella S, Alvarez Gallego M, Martin Perez E, Martinez Cortijo S, Pascual Miguelanez I, Perez Diaz L, Ramos Rodriguez JL, Espin Basany E, Sanchez Santos R, Soria Aledo V, Lopez Barrachina R, Morales-Conde S. Surgical Management of Patients With COVID-19 Infection. Recommendations of the Spanish Association of Surgeons. Cir Esp (Engl Ed). 2020 May;98(5):251-259. doi: 10.1016/j.ciresp.2020.03.001. Epub 2020 Apr 3.

    PMID: 32252979BACKGROUND
  • Brat GA, Hersey S, Chhabra K, Gupta A, Scott J. Protecting Surgical Teams During the COVID-19 Outbreak: A Narrative Review and Clinical Considerations. Ann Surg. 2023 Nov 1;278(5):e957-e959. doi: 10.1097/SLA.0000000000003926. Epub 2020 Apr 17. No abstract available.

    PMID: 32379080BACKGROUND

MeSH Terms

Conditions

Stress, PsychologicalCOVID-19

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Petros L Chalkias, MD

    Sismanoglio - Amalia Fleming General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Petros L Chalkias, MD

CONTACT

Christina Darviri

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 10, 2021

Study Start

February 8, 2021

Primary Completion

May 8, 2021

Study Completion

May 8, 2021

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations