Workplace Intervention Among Pregnant Hospital Employees

Pregnancy Clinical Trial

Official title:

Workplace Intervention Among Pregnant Hospital Employees - a Cluster Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05621512
• Other study ID #: 29-2019-03
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2023
• Source: Region MidtJylland Denmark
• Contact: Anne Mette H Momsen, Researcher
• Phone: 0045 3082 8189
• Email: Anne-Mette.Momsen[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 404
• Est. completion date: October 1, 2024
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Gest. week > 20

Related Conditions & MeSH terms

• Midwifery
• Pregnancy
• Sick Leave

Intervention

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

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
Region MidtJylland Denmark	Aarhus University Hospital, Defactum, Central Denmark Region, Herning Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	gestational period until gestational week 32
Secondary	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.	at inclusion and at gestational week 30
Secondary	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.	At inclusion and at gestational week 30
Secondary	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.	At inclusion and at gestational week 30
Secondary	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.	At inclusion and at gestational week 30
Secondary	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.	At inclusion and at gestational week 30