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Workplace Intervention Among Pregnant Hospital Employees

Workplace Intervention Among Pregnant Hospital Employees - a Cluster Randomized Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05621512
Enrollment
404
Registered
2022-11-18
Start date
2021-09-01
Completion date
2024-10-01
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Midwifery, Pregnancy, Sick Leave

Keywords

Risk factors, Health Care Professionals, Intervention, Workplace

Brief 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. 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.

Interventions

OTHERPreventive sessions

Preventive sessions between the pregnant employee, her manager and a midwife.

Sponsors

Defactum, Central Denmark Region
CollaboratorOTHER_GOV
Aarhus University Hospital
CollaboratorOTHER
Herning Hospital
CollaboratorOTHER
Region MidtJylland Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Cluster randomization

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant employees working as health care professionals at Aarhus University Hospital

Exclusion criteria

* Gest. week \> 20

Design outcomes

Primary

MeasureTime frameDescription
Number of days on sick leavegestational period until gestational week 32Sick 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)

Secondary

MeasureTime frameDescription
Self-rated healthat inclusion and at gestational week 30Self-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.
Work abilityAt inclusion and at gestational week 30Work 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.
Psycho-social working environmentAt inclusion and at gestational week 30The 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.
Relation to immediate superiorAt inclusion and at gestational week 30COPSOQ 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.
InfluenceAt inclusion and at gestational week 30COPSOQ 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.

Countries

Denmark

Contacts

Primary ContactAnne Mette H Momsen, Researcher
Anne-Mette.Momsen@rm.dk0045 3082 8189
Backup ContactPernille Pedersen, Reseracher
pelped@rm.dk0045 2447 0964

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026