Stress, PsychologicalNCT04791085
Investigation of Stress Levels and Lifestyle of a Sample of Greek General Surgeons in Covid-19
An observational study of Stress, Psychological and Stress, Emotional, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Stress, Emotional, Life Style Induced Illness
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 8 Feb 2021to 8 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Greek general surgeons and interns of general surgery working in private and general hospitals in the country.
Who may be able to join
- participants will be surgeons or interns of general surgery in any hospital in Greece.
Who cannot join
- participants who will practice another medical specialty
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Sismanoglio-Amalia Fleming Hospital
Athens, Melissia, 15127
Georgia Dedemadi, MD, 00306942554354, gdedemadi@gmail.com
About this study
Official title: Investigation of Stress Levels and Lifestyle of a Sample of Greek General Surgeons in Covid-19 and Non-reference Hospitals
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.
Read more
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.
Read the detailed description
A new pandemic emerged in early 2020, also known as the coronavirus (Covid-19) pandemic, affecting all health systems worldwide. This disease, although it attacks the human respiratory system, has greatly affected all health personnel regardless of specialty and the reason is that these patients need a high level of care. 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.
Their presence in aerosol situations (surgeries - intubation, placement of central venous catheters) and frequent contact with patients increased the likelihood of disease spread. With the increased likelihood of the disease spreading as their exposure to patients was high, it began to cause concern to staff living with the elderly or other vulnerable groups.
The incidence of the Covid-19 pandemic is increasing rapidly, resulting in worldwide healthcare systems operating feverishly to adequately meet the demands of this new disease. Several countries around the world have converted general hospitals to host hospitals exclusively for this disease, as a safety measure and limitation of the spread of Covid-19.
Front-line health personnel is under stress due to increased workload, lack of protective equipment, lack of information, and social isolation from loved ones. This staff includes physicians, pulmonologists, intensivists, surgeons.
In the last decade, there has been a great deal of mobility in the health sciences with reference to stress as many studies have linked it to the occurrence of various physical and psychological disorders. Undoubtedly, stress is a multifactorial concept, which makes it difficult to define clearly.
Stress, in particular, is a response mechanism, a "fight or flight" reflex in order to protect the body from various dangers. It is always activated with the "perception" of danger or threat (real or imaginary), where the sympathetic fate of the autonomic nervous system is stimulated and aims to prepare the body either to escape from danger or to fight with it.
The stressors that affect surgeons are many and varied, such as minimal sleep and its disturbance with multiple shifts, workplace tension, heavy workload, poor diet, etc. Depending on the stressors, the stress axis is activated with the corresponding effects on their psychosomatic health (depression, burnout, obesity, cardiovascular and autoimmune diseases).
Based on the above, the present study has not so far looked more broadly at the psychological stress of surgeons in relation to their quality of life during the Covid-19 period.
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 (social-demographic data, DASS-21, Anxiety Covid-19, Pittsburgh, Healthy Lifestyle and Personal Control Questionnaire, Multidimensional Health Locus of Control).
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.
- Conditions
- Stress, Psychological, Stress, Emotional, Life Style Induced Illness, Anxiety Depression, Covid19
- Medical subject headings
- Stress, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| general surgeons | General surgeons who work at general or private hospitals in Greece |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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+
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start8 Feb 2021
- Primary completion8 May 2021 (estimated)
- Study completion8 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- Amalia Fleming General Hospital
- Responsible party
- Principal investigator, Petros Loukas Chalkias, National and Kapodistrian University of Athens
- Investigators
- Petros L Chalkias, MD, Principal investigator, Sismanoglio - Amalia Fleming General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791085
- Sponsor's protocol ID
- 1183/17.02.21
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14993174Chan 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.
PubMed 15133143Rossi 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.
PubMed 32463467Lai 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.
PubMed 32202646Shanafelt 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.
PubMed 32259193Balibrea 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.
PubMed 32252979Brat 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.
PubMed 32379080
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Stress Levels and Lifestyle of a Sample of Greek General Surgeons in Covid-19 and Non-reference Hospitals
- ClinicalTrials.gov ID
- NCT04791085
- Acronym / sponsor ID
- 1183/17.02.21
- Conditions
- Stress, Psychological, Stress, Emotional, Life Style Induced Illness, Anxiety Depression, Covid19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Collaborators
- Amalia Fleming General Hospital
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 8 May 2021 (estimated)
- Study completion
- 8 May 2021 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A new pandemic emerged in early 2020, also known as the coronavirus (Covid-19) pandemic, affecting all health systems worldwide. This disease, although it attacks the human respiratory system, has greatly affected all health personnel regardless of specialty and the reason is that these patients need a high level of care. 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.
Their presence in aerosol situations (surgeries - intubation, placement of central venous catheters) and frequent contact with patients increased the likelihood of disease spread. With the increased likelihood of the disease spreading as their exposure to patients was high, it began to cause concern to staff living with the elderly or other vulnerable groups.
The incidence of the Covid-19 pandemic is increasing rapidly, resulting in worldwide healthcare systems operating feverishly to adequately meet the demands of this new disease. Several countries around the world have converted general hospitals to host hospitals exclusively for this disease, as a safety measure and limitation of the spread of Covid-19.
Front-line health personnel is under stress due to increased workload, lack of protective equipment, lack of information, and social isolation from loved ones. This staff includes physicians, pulmonologists, intensivists, surgeons.
In the last decade, there has been a great deal of mobility in the health sciences with reference to stress as many studies have linked it to the occurrence of various physical and psychological disorders. Undoubtedly, stress is a multifactorial concept, which makes it difficult to define clearly.
Stress, in particular, is a response mechanism, a "fight or flight" reflex in order to protect the body from various dangers. It is always activated with the "perception" of danger or threat (real or imaginary), where the sympathetic fate of the autonomic nervous system is stimulated and aims to prepare the body either to escape from danger or to fight with it.
The stressors that affect surgeons are many and varied, such as minimal sleep and its disturbance with multiple shifts, workplace tension, heavy workload, poor diet, etc. Depending on the stressors, the stress axis is activated with the corresponding effects on their psychosomatic health (depression, burnout, obesity, cardiovascular and autoimmune diseases).
Based on the above, the present study has not so far looked more broadly at the psychological stress of surgeons in relation to their quality of life during the Covid-19 period.
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 (social-demographic data, DASS-21, Anxiety Covid-19, Pittsburgh, Healthy Lifestyle and Personal Control Questionnaire, Multidimensional Health Locus of Control).
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general surgeons | – | –General surgeons who work at general or private hospitals in Greece |
Who may qualify
- Ages
- 23 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Greek general surgeons and interns of general surgery working in private and general hospitals in the country.
Key inclusion criteria (1 listed)
- participants will be surgeons or interns of general surgery in any hospital in Greece.
Key exclusion criteria (1 listed)
- participants who will practice another medical specialty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceived Stress Scale (PSS)
Time frame: day 1
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.
DASS-21
Time frame: day 1
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+
PITTSBURGH (GR-PSQI)
Time frame: day 1
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.
Healthy Lifestyle and Personal Control Questionnaire
Time frame: day 1
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.
Multi dimensional Health Locus of Control (MHLC)
Time frame: day 1
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.
COVID-19-Anxiety Questionnaire (C-19-A)
Time frame: day 1
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 14993174Nickell 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.
- Background: PubMed 15133143Chan 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.
- Background: PubMed 32463467Rossi 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.
- Background: PubMed 32202646Lai 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.
- Background: PubMed 32259193Shanafelt 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.
- Background: PubMed 32252979Balibrea 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.
- Background: PubMed 32379080Brat 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petros L Chalkias, MD principal investigator
Sismanoglio - Amalia Fleming General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress, Psychological and Stress, Emotional, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Petros L Chalkias, MD (00306985656723, p.chalkias11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS) (time frame: day 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791085, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.