Mental HealthNCT05864443
Surgeons' Mental Distress and Risks After Severe Complications Following Emergency Surgery
An observational study of Mental Health, run by Shanghai Zhongshan Hospital.
Trial summary
Surgeons experience higher levels of work stress, even under normal circumstances. Many can suffer from substantial levels of mental health issues, especially when faced with severe complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mental Health
- What is being tested?
- Severe complications following emergency surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,500 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 30 Jun 2026
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population are limited to surgeons who had previously experienced severe complications following radical gastrectomy as chief surgeons.
Who may be able to join
- Emergency surgeons who experienced severe complications after Emergency Surgery.
Who cannot join
- Other conditions that do not meet the inclusion criteria.
About this study
Official title: Surgeons' Mental Distress and Risks After Severe Complications Following Emergency Surgery in China: a Nationwide Cross-Sectional Questionnaire
Surgeons experience higher levels of work stress, even under normal circumstances. Many can suffer from substantial levels of mental health issues, especially when faced with severe complications. However, due to a variety of reasons, many surgeons are reluctant to disclose mental health issues or seek psychological help.
Patients in need of emergency surgery are usually characterized by critical conditions and high surgical risks. Emergency surgeons always do not have enough time to clearly explain the ins and outs of the disease to the family members of the patients, only tell the key issues and risks that need to be paid attention to during the operation. The tone of the explanation maybe direct and blunt, which also could cause the incomprehension and dissatisfaction of the patients and their families. Due to the lack of communication, although the patient is in critical condition, the family members always think that the disease should be cured after arriving at the hospital. Therefore, once severe complications occur after the operation, the family members often find it difficult to accept the reality. This is also one of the important reasons for medical disputes in emergency surgery.
In addition to delaying patients' recovery courses, severe complications also place enormous pressure on chief surgeons who performed the operations. Such pressures may bring great risks of psychological distress. Surgeons are also the victims when they encounter severe complications following emergency surgery. Their mental distress should not be minimized. Until now, little has been known about the effects of surgical complications on surgeons. In the current study, based on a large-scale questionnaire survey in China, the investigators aimed to investigate incidences of surgeons' mental distress following severe complications after emergency surgery. The investigators also aimed to identify independent risk factors which could help develop strategies to improve the mental well-being of these surgeons after such incidences.
- Conditions
- Mental Health
- Being tested
- Severe complications following emergency surgery
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Severe complications following emergency surgeryProcedure or surgery
The respondents are limited to surgeons who had previously experienced severe complications following emergency surgery as chief surgeons.
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeons' mental health
The clinical features collected in the questionnaire relating to the surgeons' mental distress included: i) feeling burnout, anxiety, or depression; ii) avoiding radical gastrectomy or feeling stress, slowing down the process during radical gastrectomy operations; iii) having physical reactions, including heart pounding, trouble breathing, or sweating while recalling; iv) having urges to quit being a surgeon; v) taking psychiatric medications; and vi) seeking psychological counseling. Meeting any one of the above six clinical features was regarded as having mental distress; Meeting ore or two was defined as mild mental distress, and meeting three or more was defined as severe mental distress.
Measured: July 01, 2023 to June 30, 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Mar 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864443
- Sponsor's protocol ID
- Zhongshan-HHY-02
- Status last verified
- May 2023
- First submitted
- 9 May 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeons' Mental Distress and Risks After Severe Complications Following Emergency Surgery in China: a Nationwide Cross-Sectional Questionnaire
- ClinicalTrials.gov ID
- NCT05864443
- Acronym / sponsor ID
- Zhongshan-HHY-02
- Conditions
- Mental Health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 May 2023 (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.
Surgeons experience higher levels of work stress, even under normal circumstances. Many can suffer from substantial levels of mental health issues, especially when faced with severe complications. However, due to a variety of reasons, many surgeons are reluctant to disclose mental health issues or seek psychological help.
Patients in need of emergency surgery are usually characterized by critical conditions and high surgical risks. Emergency surgeons always do not have enough time to clearly explain the ins and outs of the disease to the family members of the patients, only tell the key issues and risks that need to be paid attention to during the operation. The tone of the explanation maybe direct and blunt, which also could cause the incomprehension and dissatisfaction of the patients and their families. Due to the lack of communication, although the patient is in critical condition, the family members always think that the disease should be cured after arriving at the hospital. Therefore, once severe complications occur after the operation, the family members often find it difficult to accept the reality. This is also one of the important reasons for medical disputes in emergency surgery.
In addition to delaying patients' recovery courses, severe complications also place enormous pressure on chief surgeons who performed the operations. Such pressures may bring great risks of psychological distress. Surgeons are also the victims when they encounter severe complications following emergency surgery. Their mental distress should not be minimized. Until now, little has been known about the effects of surgical complications on surgeons. In the current study, based on a large-scale questionnaire survey in China, the investigators aimed to investigate incidences of surgeons' mental distress following severe complications after emergency surgery. The investigators also aimed to identify independent risk factors which could help develop strategies to improve the mental well-being of these surgeons after such incidences.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are limited to surgeons who had previously experienced severe complications following radical gastrectomy as chief surgeons.
Key inclusion criteria (1 listed)
- Emergency surgeons who experienced severe complications after Emergency Surgery.
Key exclusion criteria (1 listed)
- Other conditions that do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Severe complications following emergency surgeryThe respondents are limited to surgeons who had previously experienced severe complications following emergency surgery as chief surgeons. | Procedure or surgery | – |
Primary outcome
Surgeons' mental health
Time frame: July 01, 2023 to June 30, 2026
The clinical features collected in the questionnaire relating to the surgeons' mental distress included: i) feeling burnout, anxiety, or depression; ii) avoiding radical gastrectomy or feeling stress, slowing down the process during radical gastrectomy operations; iii) having physical reactions, including heart pounding, trouble breathing, or sweating while recalling; iv) having urges to quit being a surgeon; v) taking psychiatric medications; and vi) seeking psychological counseling. Meeting any one of the above six clinical features was regarded as having mental distress; Meeting ore or two was defined as mild mental distress, and meeting three or more was defined as severe mental distress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health, run by Shanghai Zhongshan Hospital.
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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Surgeons' mental health (time frame: July 01, 2023 to June 30, 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2024.