Sick LeaveNCT05621512
Workplace Intervention Among Pregnant Hospital Employees
A study testing Preventive sessions in people with Sick Leave and Pregnancy, run by Region MidtJylland Denmark at 1 site in Denmark.
Trial summary
The aim of this study is to reduce sick leave and improve wellbeing. This is measured as physical and mental health, general work ability, work-life balance, manager support and completed work adjustments among pregnant health care professionals. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sick Leave, Pregnancy, Midwifery
- What is being tested?
- Preventive sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 1 Oct 2024
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant employees working as health care professionals at Aarhus University Hospital
Who cannot join
- Gest. week > 20
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, 8200
Rikke D Maimburg, Researcher, rikkmaim@rm.dk
Jane B Lauridsen, Ph.d student, janelaur@rm.dk
About this study
Official title: Workplace Intervention Among Pregnant Hospital Employees - a Cluster Randomized Trial
The aim of this study is to reduce sick leave and improve wellbeing. This is measured as physical and mental health, general work ability, work-life balance, manager support and completed work adjustments among pregnant health care professionals. It is hypothesised that pregnant employees participating in preventive sessions with their manager and a midwife in addition to the hospital standard pregnancy policy management will have less sick leave and report better wellbeing compared to the reference group.
Read the detailed description
Sick leave during pregnancy is frequent and studies report proportions of employees on sick leave between 36-75%. Reasons for sick leave in early pregnancy are nausea, vomiting and dizziness whereas Braxton Hicks contractions, low back and pelvic girdle pain are more common in late pregnancy. Further, sick leave is strongly associated with working conditions and appropriate work adjustment.
The study design is cluster randomization with participation of all departments at Aarhus University Hospital (AUH), Denmark. Half of the departments are randomized to the intervention and the remaining to the reference group. The intervention group will receive a protocolized intervention with midwifery support as an add-on to usual practice. The reference group will receive protocolized usual practice.
Data are obtained from the hospital payment system and by survey (RedCap).
The sample size is calculated to find a difference of ≥ 7 days with a standard deviation of 25. To achieve a statistical power of 80% with a significance level of p ≤ 0.05 an estimated 202 participants will be required in each of the groups.
- Conditions
- Sick Leave, Pregnancy, Midwifery
- Being tested
- Preventive sessions
- Keywords
- Risk factors, Health Care Professionals, Intervention, Workplace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive sessionsOther
Preventive sessions between the pregnant employee, her manager and a midwife.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention implies a letter of invitation for a session between the employee, the department manager, and a midwife concerning workplace risk assessment and agreement on feasible work adjustments if necessary. A second session within gestational week 26-28 is scheduled to follow-up and readjust if necessary. A systematic frame for sessions is developed by the research team and conclusions from the sessions are registered within a piloted standardized template.
The employee and the manager can initiate contact with the midwife at any time, e.g in case of new symptoms or discomfort and need for support or guidance. If sick leave is considered, a new session is recommended and may be scheduled at any time.
To ensure transparency of guidance and workplace adjustments for other relevant healthcare professionals, the employee is asked to inform her general practitioner (GP) and midwife of the program. Receives: Other: Preventive sessions |
| Usual practice | No intervention | Hospital pregnancy policy is usual practice and implies a meeting between the pregnant employee and her manager concerning an individual risk assessment. A risk assessment-template can be downloaded from the hospital website. If minimizing potential risks by adjustments is not possible the employee should be redeployed. If redeployment is not possible the pregnant employee may be absent due to pregnancy related symptoms. The pregnant employee is requested to inform her GP about agreements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days on sick leave
Sick leave is specified by mean number of days on sick leave and the proportion of employees on sick leave throughout pregnancy and within trimesters (first trimester defined as gestational week 1 - 12, second trimester being gestational week 13 - 27 and third trimester being gestational week 28 - maternity leave)
Measured: gestational period until gestational week 32
Secondary outcomes (5)
Self-rated health
Self-rated health is explored with the item from Short Form 36 Health Survey Questionnaire: "In general, would you say your health is?: Excellent, very good, good, fair and poor?" Item values are coded from 1-5 with 1 being "excellent". Self-rated health is specified by mean scores.
Measured: at inclusion and at gestational week 30
Work ability
Work ability is explored with three items from The Work Ability Index: "Assume that your work ability at its best has a value of 10 points. How many points would you give to your current work ability?" with answers on a scale from 1-10. Furthermore, "How do you rate your current work ability with respect to the physical demands of your work?" and "How do you rate your current work ability with respect to the mental demands of your work?" are included with response choices: "Very good, rather good, moderate, rather poor, very poor". Answers are coded 1-5 with 1 being "very poor". Work ability is specified by mean scores.
Measured: At inclusion and at gestational week 30
Psycho-social working environment
The Copenhagen Psychosocial Questionnaire short version (COPSOQ) explores psycho-social working environment with the items: "How often have you felt worn out?" and "How often have you been emotionally exhausted?". Response choices are: "All the time, a large part of the time, part of the time, a small part of the time, not at all". Responses are coded from 1-5 with 1 being "all the time". The dimension of influence is explored with the questions: "Do you have a large degree of influence concerning your work?" and "Can you influence the amount of work assigned to you?" with response choices: "Always, often, sometimes, seldom, never/hardly ever". Answers are coded 1-5 with 1 being never/hardly. Psycho-social working environment is specified by mean scores.
Measured: At inclusion and at gestational week 30
Relation to immediate superior
COPSOQ explores the dimension of relation to immediate superior is included with the items: "To what extend would you say that your immediate superior gives high priority to job satisfaction?" and "To what extend would you say that your immediate superior is good at work planning" Response choices are: "To a very large extend, to a large extend, somewhat, to a small extend, to a very small extend". Answers are coded from 1-5 with 1 being "to a very small extend". Relation to immediate superior is specified by mean scores.
Measured: At inclusion and at gestational week 30
Influence
COPSOQ explores the dimension of influence is explored with the questions: "Do you have a large degree of influence concerning your work?" and "Can you influence the amount of work assigned to you?" with response choices: "Always, often, sometimes, seldom, never/hardly ever". Answers are coded 1-5 with 1 being never/hardly. Influence is specified by mean scores.
Measured: At inclusion and at gestational week 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Sep 2021
- Primary completion31 Aug 2023 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick LeaveStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomization
- Masking
- None (open label)
- Enrolment
- 404 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region MidtJylland Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Defactum, Central Denmark Region, Aarhus University Hospital, Herning Hospital
- Responsible party
- Principal investigator, Rikke Damkjær Maimburg, University of Aarhus
- Investigators
- Thomas Maribo, Reseracher, Study chair, Region MidtJylland Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621512
- Sponsor's protocol ID
- 29-2019-03
- Status last verified
- Mar 2023
- First submitted
- 16 Jun 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workplace Intervention Among Pregnant Hospital Employees - a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05621512
- Acronym / sponsor ID
- 29-2019-03
- Conditions
- Sick Leave, Pregnancy, Midwifery
- Keywords
- Risk factors, Health Care Professionals, Intervention, Workplace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 404 participants (estimated)
- Lead sponsor
- Region MidtJylland DenmarkUniversity, hospital or other
- Collaborators
- Defactum, Central Denmark Region, Aarhus University Hospital, Herning Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 18 Nov 2022 (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 reduce sick leave and improve wellbeing. This is measured as physical and mental health, general work ability, work-life balance, manager support and completed work adjustments among pregnant health care professionals. It is hypothesised that pregnant employees participating in preventive sessions with their manager and a midwife in addition to the hospital standard pregnancy policy management will have less sick leave and report better wellbeing compared to the reference group.
Detailed description
Sick leave during pregnancy is frequent and studies report proportions of employees on sick leave between 36-75%. Reasons for sick leave in early pregnancy are nausea, vomiting and dizziness whereas Braxton Hicks contractions, low back and pelvic girdle pain are more common in late pregnancy. Further, sick leave is strongly associated with working conditions and appropriate work adjustment.
The study design is cluster randomization with participation of all departments at Aarhus University Hospital (AUH), Denmark. Half of the departments are randomized to the intervention and the remaining to the reference group. The intervention group will receive a protocolized intervention with midwifery support as an add-on to usual practice. The reference group will receive protocolized usual practice.
Data are obtained from the hospital payment system and by survey (RedCap).
The sample size is calculated to find a difference of ≥ 7 days with a standard deviation of 25. To achieve a statistical power of 80% with a significance level of p ≤ 0.05 an estimated 202 participants will be required in each of the groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomization
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Preventive sessionsThe intervention implies a letter of invitation for a session between the employee, the department manager, and a midwife concerning workplace risk assessment and agreement on feasible work adjustments if necessary. A second session within gestational week 26-28 is scheduled to follow-up and readjust if necessary. A systematic frame for sessions is developed by the research team and conclusions from the sessions are registered within a piloted standardized template. The employee and the manager can initiate contact with the midwife at any time, e.g in case of new symptoms or discomfort and need for support or guidance. If sick leave is considered, a new session is recommended and may be scheduled at any time. To ensure transparency of guidance and workplace adjustments for other relevant healthcare professionals, the employee is asked to inform her general practitioner (GP) and midwife of the program. |
| Usual practice | No intervention | –Hospital pregnancy policy is usual practice and implies a meeting between the pregnant employee and her manager concerning an individual risk assessment. A risk assessment-template can be downloaded from the hospital website. If minimizing potential risks by adjustments is not possible the employee should be redeployed. If redeployment is not possible the pregnant employee may be absent due to pregnancy related symptoms. The pregnant employee is requested to inform her GP about agreements. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant employees working as health care professionals at Aarhus University Hospital
Key exclusion criteria (1 listed)
- Gest. week > 20
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 |
|---|---|---|
| Preventive sessionsPreventive sessions between the pregnant employee, her manager and a midwife. | Other | Intervention |
Primary outcome
Number of days on sick leave
Time frame: gestational period until gestational week 32
Sick leave is specified by mean number of days on sick leave and the proportion of employees on sick leave throughout pregnancy and within trimesters (first trimester defined as gestational week 1 - 12, second trimester being gestational week 13 - 27 and third trimester being gestational week 28 - maternity leave)
5 secondary outcomes
Self-rated health
Time frame: at inclusion and at gestational week 30
Work ability
Time frame: At inclusion and at gestational week 30
Psycho-social working environment
Time frame: At inclusion and at gestational week 30
Relation to immediate superior
Time frame: At inclusion and at gestational week 30
Influence
Time frame: At inclusion and at gestational week 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- 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.
Thomas Maribo, Reseracher study chair
Region MidtJylland Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive sessions in people with Sick Leave and Pregnancy, run by Region MidtJylland Denmark at 1 site in Denmark.
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 29 Mar 2023. 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 Denmark. 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 Anne Mette H Momsen, Researcher (0045 3082 8189, Anne-Mette.Momsen@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days on sick leave (time frame: gestational period until gestational week 32). 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 29 Mar 2023.