Burnout SyndromeNCT03668080
Burnout Syndrome Among Medical Residents
An observational study of Burnout Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Whether and to what extent burnout risk is actually higher in surgical specialties than in non-surgical specialties is still unknown. Little is also known about what factors are associated with burnout between surgical residents and non-surgical residents. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout Syndrome
- How many people
- 679 participants
- Where
- 1 siteItaly
- Study dates
- 16 Oct 2017to 6 Nov 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All the residents attending the University of Bologna in the academic year 2017/2018
Who may be able to join
- residents attending the University of Bologna
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Whether and to what extent burnout risk is actually higher in surgical specialties than in non-surgical specialties is still unknown. Little is also known about what factors are associated with burnout between surgical residents and non-surgical residents. In this context, the present study has a three-fold aim: 1) to measure the prevalence of burnout among a sample of Italian medical residents; 2) to contrast the prevalence of burnout and psychological distress in surgical residents and non-surgical residents, and 3) to identify the work-related factors associated with burnout between surgical residents and non-surgical residents.
Read the detailed description
Surgical training is considered to be very stressful among residents and graduating medical students choose less often surgery for their career. To elaborate burnout prevention programs, the assessment of the prevalence of burnout during the early career stage of the surgeons and associated risk factors, becomes central.
Residents from the University of Bologna were asked to participate in an anonymous online survey. The residents completed a set of questions regarding their training schedule and three standardized questionnaires: 1) the Maslach Burnout Inventory, assessing the three dimensions of burnout: emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA); 2) the Zung Self-Rating Depression scale; 3) the Psychosomatic Problems scale. High scores in either the EE or DP subscale categories predicted professional burnout.
- Conditions
- Burnout Syndrome
- Keywords
- burnout, residents, surgical residents
- Medical subject headings
- Burnout, Psychological
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 |
|---|---|---|
| surgical residents | Surgical specialties included general surgery, plastic surgery, urology, vascular surgery, obstetrics and gynecology, orthopedic surgery, pediatric surgery, cardiothoracic surgery and otolaryngology. | |
| non-surgical residents | Non-surgical specialties included cardiology, rheumatology, neurology, pulmonary disease, endocrinology, nuclear medicine, pediatrics, psychiatry, internal medicine, oncology, nephrology, hygiene and preventive medicine, anesthesiology, child and adolescent psychiatry, radiology, radiation oncology, infectious disease, dermatology, pathology, microbiology, hematology, gastroenterology, geriatric medicine, medical genetics, sports medicine, occupational and environmental medicine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach Burnout Inventory
a validated 22-item questionnaire that evaluates burnout in its three dimensions: emotional exhaustion (EE) depersonalization (DP) and personal accomplishment (PA). Responses are made on a 7-point Likert scale ranging from 0 ("never") to 6 ("daily").
Measured: 3 months
Secondary outcomes (2)
Zung Self-Rating Depression Scale
The level of depressive symptoms was measured using the 20-item Zung Self-Rating Depression Scale. Items responses rank from 1 ("none or little of the time") to 4 ("most or all of the time"), and the total score range from 20 to 80 points. A score of 50 and above indicated the presence of at least mild-moderate depressive symptoms.
Measured: 3 months
Psychosomatic Problems Scale
Psychosomatic symptoms were measured using the Psychosomatic Problems Scale, which consists of 8 items: difficulty concentrating, sleep problems, headache, stomachache, tensions, lack of appetite, feeling sad, and dizziness. Responses are rated on a 5-point Likert scale, ranging from 1 ("never") to 5 ("always"). Participants answering "often" or "always" on an item are coded as having a psychosomatic symptom.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start16 Oct 2017
- Primary completion5 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burnout SyndromeStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Other
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, matteo serenari, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- antonio d pinna, MD, Study director, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668080
- Sponsor's protocol ID
- 105543
- Status last verified
- Sep 2018
- First submitted
- 9 Sep 2018
- Last updated
- 12 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. doi: 10.1146/annurev.psych.52.1.397.
PubMed 11148311Serenari M, Cucchetti A, Russo PM, Fallani G, Mattarozzi K, Pinna AD, Colonnello V, Poggioli G, Cescon M. Burnout and psychological distress between surgical and non-surgical residents. Updates Surg. 2019 Jun;71(2):323-330. doi: 10.1007/s13304-019-00653-0. Epub 2019 Apr 2.
PubMed 30941702
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burnout Syndrome Among Medical Residents
- ClinicalTrials.gov ID
- NCT03668080
- Acronym / sponsor ID
- 105543
- Conditions
- Burnout Syndrome
- Keywords
- burnout, residents, surgical residents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 5 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 12 Sep 2018 (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.
Whether and to what extent burnout risk is actually higher in surgical specialties than in non-surgical specialties is still unknown. Little is also known about what factors are associated with burnout between surgical residents and non-surgical residents. In this context, the present study has a three-fold aim: 1) to measure the prevalence of burnout among a sample of Italian medical residents; 2) to contrast the prevalence of burnout and psychological distress in surgical residents and non-surgical residents, and 3) to identify the work-related factors associated with burnout between surgical residents and non-surgical residents.
Detailed description
Surgical training is considered to be very stressful among residents and graduating medical students choose less often surgery for their career. To elaborate burnout prevention programs, the assessment of the prevalence of burnout during the early career stage of the surgeons and associated risk factors, becomes central.
Residents from the University of Bologna were asked to participate in an anonymous online survey. The residents completed a set of questions regarding their training schedule and three standardized questionnaires: 1) the Maslach Burnout Inventory, assessing the three dimensions of burnout: emotional exhaustion (EE), depersonalization (DP), and personal accomplishment (PA); 2) the Zung Self-Rating Depression scale; 3) the Psychosomatic Problems scale. High scores in either the EE or DP subscale categories predicted professional burnout.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical residents | – | –Surgical specialties included general surgery, plastic surgery, urology, vascular surgery, obstetrics and gynecology, orthopedic surgery, pediatric surgery, cardiothoracic surgery and otolaryngology. |
| non-surgical residents | – | –Non-surgical specialties included cardiology, rheumatology, neurology, pulmonary disease, endocrinology, nuclear medicine, pediatrics, psychiatry, internal medicine, oncology, nephrology, hygiene and preventive medicine, anesthesiology, child and adolescent psychiatry, radiology, radiation oncology, infectious disease, dermatology, pathology, microbiology, hematology, gastroenterology, geriatric medicine, medical genetics, sports medicine, occupational and environmental medicine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the residents attending the University of Bologna in the academic year 2017/2018
Key inclusion criteria (1 listed)
- residents attending the University of Bologna
Key exclusion criteria (1 listed)
- none
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
Maslach Burnout Inventory
Time frame: 3 months
a validated 22-item questionnaire that evaluates burnout in its three dimensions: emotional exhaustion (EE) depersonalization (DP) and personal accomplishment (PA). Responses are made on a 7-point Likert scale ranging from 0 ("never") to 6 ("daily").
2 secondary outcomes
Zung Self-Rating Depression Scale
Time frame: 3 months
Psychosomatic Problems Scale
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2018.
- Results publication: PubMed 11148311Maslach C, Schaufeli WB, Leiter MP. Job burnout. Annu Rev Psychol. 2001;52:397-422. doi: 10.1146/annurev.psych.52.1.397.
- Derived from this study: PubMed 30941702Serenari M, Cucchetti A, Russo PM, Fallani G, Mattarozzi K, Pinna AD, Colonnello V, Poggioli G, Cescon M. Burnout and psychological distress between surgical and non-surgical residents. Updates Surg. 2019 Jun;71(2):323-330. doi: 10.1007/s13304-019-00653-0. Epub 2019 Apr 2.
- 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.
antonio d pinna, MD study director
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Burnout Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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: finished, as of the sponsor's last update on 12 Sep 2018. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maslach Burnout Inventory (time frame: 3 months). 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 NCT03668080, which also lists 2 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 12 Sep 2018.