StressSTRAINNCT03508596
STRAIN - Work-related Stress Among Health Professionals in Switzerland
A study testing educational intervention for the supervisors in people with Stress and Health Care Professionals, run by Sabine Hahn.
Trial summary
The aim of this study is to identify work stressors, stress reactions and long-term consequences among nurses, physicians, medical-technical and medical-therapeutic professions in Switzerland and to reduce those factors by an educational intervention for the supervisors. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Health Care Professionals, Work-Related Condition
- What is being tested?
- educational intervention for the supervisors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,112 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- Phase
- Interventional
- 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 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employee within a participating health organization in Switzerland
- Health care professional (nurse, medical-technical medical-therapeutical profession, physician)
Who cannot join
- Health professionals without an fixed employment contract
About this study
The aim of this study is to identify work stressors, stress reactions and long-term consequences among nurses, physicians, medical-technical and medical-therapeutic professions in Switzerland and to reduce those factors by an educational intervention for the supervisors.
Read the detailed description
Methods: This study is a cross-sectional design and randomly selected hospitals, nursing homes and home care organizations. The study sample included nursing staff and midwives, physicians, medical-technical and medical-therapeutic professionals at all hierarchical levels. Data were collected using self-report questionnaires and analysed using multiple regression models.
- Conditions
- Stress, Health Care Professionals, Work-Related Condition
- Being tested
- educational intervention for the supervisors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational intervention for the supervisorsOther
The educational intervention is based on a systematic literature review as well as focus-group interviews with health care professionals. It will be developed until the end of 2018
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group (IG)
An educational intervention for the supervisors Receives: Other: educational intervention for the supervisors |
| Control | No intervention | control group (CG) |
| Non-Intervention | No intervention | group without intervention (GWI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
effort reward imbalance model (ERI)
The model defines threatening job conditions as a "mismatch between high workload (high demand) and low control over long-term rewards"
Measured: Changes in self reported results of the ERI from t1 to t2 (1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study startJan 2017
- Primary completionJun 2018
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sabine Hahn
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland, University of Applied Sciences of Western Switzerland
- Responsible party
- Sponsor-investigator, Sabine Hahn, Bern University of Applied Sciences
- Investigators
- Sabine Hahn, Study director, Bern University of Applied Sciences Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508596
- Sponsor's protocol ID
- J.008137-42-PFLW
- Acronym
- STRAIN
- Status last verified
- Jul 2020
- First submitted
- 23 Mar 2018
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRAIN - Work-related Stress Among Health Professionals in Switzerland
- ClinicalTrials.gov ID
- NCT03508596
- Acronym / sponsor ID
- STRAIN / J.008137-42-PFLW
- Conditions
- Stress, Health Care Professionals, Work-Related Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,112 participants (actual)
- Lead sponsor
- Sabine HahnUniversity, hospital or other
- Collaborators
- University of Applied Sciences and Arts of Southern Switzerland, University of Applied Sciences of Western Switzerland
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 26 Apr 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.
The aim of this study is to identify work stressors, stress reactions and long-term consequences among nurses, physicians, medical-technical and medical-therapeutic professions in Switzerland and to reduce those factors by an educational intervention for the supervisors.
Detailed description
Methods: This study is a cross-sectional design and randomly selected hospitals, nursing homes and home care organizations. The study sample included nursing staff and midwives, physicians, medical-technical and medical-therapeutic professionals at all hierarchical levels. Data were collected using self-report questionnaires and analysed using multiple regression models.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: educational intervention for the supervisorsIntervention group (IG) An educational intervention for the supervisors |
| Control | No intervention | –control group (CG) |
| Non-Intervention | No intervention | –group without intervention (GWI) |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employee within a participating health organization in Switzerland
- Health care professional (nurse, medical-technical medical-therapeutical profession, physician)
Key exclusion criteria (1 listed)
- Health professionals without an fixed employment contract
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 |
|---|---|---|
| educational intervention for the supervisorsThe educational intervention is based on a systematic literature review as well as focus-group interviews with health care professionals. It will be developed until the end of 2018 | Other | Intervention |
Primary outcome
effort reward imbalance model (ERI)
Time frame: Changes in self reported results of the ERI from t1 to t2 (1 year)
The model defines threatening job conditions as a "mismatch between high workload (high demand) and low control over long-term rewards"
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 16 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
Sabine Hahn study director
Bern University of Applied Sciences Switzerland
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention for the supervisors in people with Stress and Health Care Professionals, run by Sabine Hahn.
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 2 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 16 Jul 2020. 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?
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?
effort reward imbalance model (ERI) (time frame: Changes in self reported results of the ERI from t1 to t2 (1 year)). 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 16 Jul 2020.