Nightshift WorkNCT04123015
Clinical Activity During Night-shift: an Ecological Study
An observational study of Nightshift Work and Handoff Sessions, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
A convenient sample of internal medicine residents will be observed during their nightshift work in the wards of the department of internal medicine of a university hospital. The epidemiology of night calls and emergencies, including incidence, causes, management, and prognosis, will be assessed prospectively. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nightshift Work, Handoff Sessions, Stress, Psychological
- How many people
- 41 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Oct 2019to 21 Apr 2020
- 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: see above
Who may be able to join
- resident in training in the internal medicine department, involved in one or more nightshift during the study
Who cannot join
- unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
A convenient sample of internal medicine residents will be observed during their nightshift work in the wards of the department of internal medicine of a university hospital. The epidemiology of night calls and emergencies, including incidence, causes, management, and prognosis, will be assessed prospectively. The impact of nightshift work on sleep, stress, quality of life, regrets, and general well being of the residents observed will be measured through completion of validated questionnaires. Quality of handoff sessions will also be assessed.
Read the detailed description
Various medical problems of patients admitted to an internal medicine ward can worsen during the stay. Furthermore, new, unidentified problems can develop (complications, medication errors, delirium, acute anxiety or pain, etc). During evenings, nights and week-ends, emergent needs of hospitalized patients are usually cared for by physicians in-training, who are in charge of a large number of patients. Hence, physicians should have a wide range of medical knowledge and procedural skills and know how acute problems are dealt with in the unique environment of the healthcare institution. Training physicians should also be able to obtain information and counseling efficiently, either from clinical guidelines, senior supervisors, or specialists.
These requirements may represent a significant stress for training physicians and may have a major impact on their health, quality of life, and finally on the quality of inpatient care. Nightshift work may lead later to a high burden of regrets among caregivers.
Better knowledge of training needs, organization features, coping strategies, and regrets associated with nightshift duty are important to prepare training physicians to that demanding and necessary task. Understanding of the epidemiology of night-shift ward emergencies could provide guidance concerning the required level of staffing and training of the responding medical team.
Furthermore, efficient transmission of information between day and night staff (so-called handoffs) is a difficult yet important part of care. Systematic observation of handoff sessions between physicians before and after nightshifts may enhance previous knowledge on key components of these topics.
The investigators will evaluate the incidence causes, and prognosis of night-shift emergencies in internal medicine wards by direct observation of the nightshift work of a convenient sample of internal medicine residents. By the means of before-and-after shift completion of various validated questionnaires, the investigators will explore quantitatively and qualitatively the physiological and psychological impact on nightshift work for physicians in training.
The planned study will also provide qualitative and quantitative data concerning handoffs session, and the repercussions on night shift emergencies management.
- Conditions
- Nightshift Work, Handoff Sessions, Stress, Psychological, Regret, Sleep
- Medical subject headings
- Stress, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of nightshift interventions
Measured: 12 hours
% of patients with nightshift interventions of different intensity
Rated on an ad-hoc scale (from "phone intervention only" to "active resuscitation")
Measured: 12 hours
% of patients with different causes of nightshift interventions
Rated on an ad-hoc scale listing the different causes (e.g. acute confusion; chest pain, etc)
Measured: 12 hours
Incidence of selected outcomes of nightshift intervention
Rated on an ad-hoc scale (from "death" to "problem resolves without further intervention"
Measured: 24 hours
Incidence of specific interventions during nightshift
Rated on an ad-hoc list, from "Provision of CPR or intubation" to "Prescription of any new drug"
Measured: 12 hours
Incidence of predictable nightshift emergencies
Rated on an ad-hoc scale, from "Unexpected" to "Expected"
Measured: 12 hours
Incidence of preventable nightshift emergencies
Rated on an ad-hoc scale, from "Unpreventable" to "Very likely preventable"
Measured: 12 hours
Secondary outcomes (8)
incidence of sleep problems in nightshift residents
Measured: 30 days
severity of sleep problems in nightshift residents
measured with the insomnia severity index questionnaire, ISI
Measured: 30 days
incidence of stress symptoms in nightshift residents
Measured: 30 days
severity of stress symptoms in nightshift residents
Measured with an ad hoc scale (From "no stress at all" to "intense stress most of the time")
Measured: 30 days
incidence of regrets in nightshift residents
Measured: 30 days
severity of regrets in nightshift residents
Measured with the regret intensity questionnaire(RIS-10)
Measured: 30 days
incidence of burnout symptoms in nightshift residents
Measured: 30 days
severity of burnout symptoms in nightshift residents
Measured with the Copenhagen Burnout Inventory, CBI
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start3 Oct 2019
- Primary completion21 Apr 2020
- Study completion21 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nightshift WorkStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauline Darbellay Farhoumand, University Hospital, Geneva
- Investigators
- Pauline DARBELLAY FARHOUMAND, MD, Principal investigator, Geneva University Hospitals, General Internal Medicine Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123015
- Sponsor's protocol ID
- SMIG_001
- Status last verified
- Aug 2020
- First submitted
- 3 Oct 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berner A, Buclin CP, Courvoisier D, Reny JL, Garin N, Serratrice J, Agoritsas T, Darbellay Farhoumand P. Negative impact of a 1-month period of night shifts on mental and physical health among Swiss internal medicine residents. Swiss Med Wkly. 2026 Sep 30;156:4027. doi: 10.57187/4027.
PubMed 42896038
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Activity During Night-shift: an Ecological Study
- ClinicalTrials.gov ID
- NCT04123015
- Acronym / sponsor ID
- SMIG_001
- Conditions
- Nightshift Work, Handoff Sessions, Stress, Psychological, Regret, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 3 Oct 2019 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 21 Apr 2020 (actual)
- First posted
- 10 Oct 2019 (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 convenient sample of internal medicine residents will be observed during their nightshift work in the wards of the department of internal medicine of a university hospital. The epidemiology of night calls and emergencies, including incidence, causes, management, and prognosis, will be assessed prospectively. The impact of nightshift work on sleep, stress, quality of life, regrets, and general well being of the residents observed will be measured through completion of validated questionnaires. Quality of handoff sessions will also be assessed.
Detailed description
Various medical problems of patients admitted to an internal medicine ward can worsen during the stay. Furthermore, new, unidentified problems can develop (complications, medication errors, delirium, acute anxiety or pain, etc). During evenings, nights and week-ends, emergent needs of hospitalized patients are usually cared for by physicians in-training, who are in charge of a large number of patients. Hence, physicians should have a wide range of medical knowledge and procedural skills and know how acute problems are dealt with in the unique environment of the healthcare institution. Training physicians should also be able to obtain information and counseling efficiently, either from clinical guidelines, senior supervisors, or specialists.
These requirements may represent a significant stress for training physicians and may have a major impact on their health, quality of life, and finally on the quality of inpatient care. Nightshift work may lead later to a high burden of regrets among caregivers.
Better knowledge of training needs, organization features, coping strategies, and regrets associated with nightshift duty are important to prepare training physicians to that demanding and necessary task. Understanding of the epidemiology of night-shift ward emergencies could provide guidance concerning the required level of staffing and training of the responding medical team.
Furthermore, efficient transmission of information between day and night staff (so-called handoffs) is a difficult yet important part of care. Systematic observation of handoff sessions between physicians before and after nightshifts may enhance previous knowledge on key components of these topics.
The investigators will evaluate the incidence causes, and prognosis of night-shift emergencies in internal medicine wards by direct observation of the nightshift work of a convenient sample of internal medicine residents. By the means of before-and-after shift completion of various validated questionnaires, the investigators will explore quantitatively and qualitatively the physiological and psychological impact on nightshift work for physicians in training.
The planned study will also provide qualitative and quantitative data concerning handoffs session, and the repercussions on night shift emergencies management.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- see above
Key inclusion criteria (1 listed)
- resident in training in the internal medicine department, involved in one or more nightshift during the study
Key exclusion criteria (1 listed)
- unwilling to participate
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
Incidence of nightshift interventions
Time frame: 12 hours
% of patients with nightshift interventions of different intensity
Time frame: 12 hours
Rated on an ad-hoc scale (from "phone intervention only" to "active resuscitation")
% of patients with different causes of nightshift interventions
Time frame: 12 hours
Rated on an ad-hoc scale listing the different causes (e.g. acute confusion; chest pain, etc)
Incidence of selected outcomes of nightshift intervention
Time frame: 24 hours
Rated on an ad-hoc scale (from "death" to "problem resolves without further intervention"
Incidence of specific interventions during nightshift
Time frame: 12 hours
Rated on an ad-hoc list, from "Provision of CPR or intubation" to "Prescription of any new drug"
Incidence of predictable nightshift emergencies
Time frame: 12 hours
Rated on an ad-hoc scale, from "Unexpected" to "Expected"
Incidence of preventable nightshift emergencies
Time frame: 12 hours
Rated on an ad-hoc scale, from "Unpreventable" to "Very likely preventable"
8 secondary outcomes
incidence of sleep problems in nightshift residents
Time frame: 30 days
severity of sleep problems in nightshift residents
Time frame: 30 days
incidence of stress symptoms in nightshift residents
Time frame: 30 days
severity of stress symptoms in nightshift residents
Time frame: 30 days
incidence of regrets in nightshift residents
Time frame: 30 days
severity of regrets in nightshift residents
Time frame: 30 days
incidence of burnout symptoms in nightshift residents
Time frame: 30 days
severity of burnout symptoms in nightshift residents
Time frame: 30 days
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 2 Sep 2020.
- Derived from this study: PubMed 42896038Berner A, Buclin CP, Courvoisier D, Reny JL, Garin N, Serratrice J, Agoritsas T, Darbellay Farhoumand P. Negative impact of a 1-month period of night shifts on mental and physical health among Swiss internal medicine residents. Swiss Med Wkly. 2026 Sep 30;156:4027. doi: 10.57187/4027.
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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.
Pauline DARBELLAY FARHOUMAND, MD principal investigator
Geneva University Hospitals, General Internal Medicine Department
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 Nightshift Work and Handoff Sessions, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 Sep 2020. 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 Switzerland. 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?
Incidence of nightshift interventions (time frame: 12 hours). The study lists 7 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 NCT04123015, which also lists 1 linked publication.
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 2 Sep 2020.