The Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers

NCT06836323 | Recruiting

• 1 other identifier: 2023-01953
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

Due to highly specialized medical care neonatal care providers are faced with numerous responsibilities which makes neonatal care a particularly challenging and stressful work environment. Moral Distress (MoD) is an increasingly perceived phenomenon, which occurs if a person is prevented from doing what she or he believe is morally right. Such situations are common in neonatal care and MoD has severe negative consequences, including burnout and resignation. There is a significant gap of knowledge on the prevalence of MoD among neonatal care providers. In addition, the complex interplay between MoD and burnout is largely unexplored. The understanding of MoD and the exploration of possible influencing factors are indispensable prerequisites for effectively targeting and mitigating the negative effects of MoD. Aims: This project aims at providing normative data on the prevalence of MoD among neonatal care providers in German speaking Switzerland. This project will further explore the interplay between MoD and burnout as well as the role of protective and reinforcing factors including moral resilience, perceived stress, mental health and workload. Design: A prospective observational mixed methods study will be conducted among neonatal care providers in Swiss secondary and tertiary care neonatal units. Over a one-year period, neonatal care providers will be repeatedly asked to answer a survey on MoD and associated outcomes. Semi-structured interviews will be performed to gain detailed information on what constitutes MoD. Significance: The study results will allow a robust assessment of the extent of MoD in the neonatal care environment. They will further provide information regarding the feasibility of a continuous screening approach. In the effort to optimize the work environment of healthcare workers in ethically complex clinical settings, in-depth exploration MoD is indispensable. The results of this study may help establish an approach to continuous assessment, and thus provide a basis for verifiable interventions.

Conditions

Moral Distress

Keywords

Neonatal intensive care; Preterm; Moral distress; Resilience; Burnout; Workload

Outcome Measures

Primary Outcomes (1)

• Moral Distress

  Composite score (frequency x intensity) of the Revised Moral Distress Scale (MDS-R). The MDS-R is a more specific 21-item instrument that allows evaluating the frequency and intensity of MoD in clinical contexts. (There is a 0 to 4 Likert score for each questions for frequency and intensity Then for each item, the frequency × intensity (fxi) score is calculated, which ranges from 0 to 16. Next, the composite score is obtained by summing each item's fxi score. The resulting score based on 21 items has a range of 0-336. A higher score indicating a more frequent and more intense Moral Distress)

  1 year

Secondary Outcomes (5)

• Secondary endpoints

  1 year

• Secondary endpoints

  1 year

• Secondary endpoints

  1 year

• Secondary endpoints

  1 year

• Secondary endpoints

  1 year

Other Outcomes (2)

• Further outcomes

  1 year

• Further outcomes

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neonatal care providers will be approached locally by the researchers themselves. Selection will be based on the list of inclusion criteria. Informed consent: Participants will receive electronic study information in REDCap, via e-mail and podcast and will give written informed consent at the time of recruitment. Participation is completely voluntary and no negative consequences will arise when participation is denied. Participants are informed that they may withdraw from the study at any time without consequence.

You may qualify if:

• Neonatal care providers working in a Department of Neonatology or a Department of Pediatric Intensive Care Medicine with focus on neonates, regardless of professional group or level of education (all health care professionals - e.g., nurses, neonatologists, intensivists, residents, psychologists, fellows, nursing and medical students).
• At least 2 weeks of practice on the unit in the 3 months prior to each survey.
• Written informed consent
• Self-reported sufficient knowledge of the German language

You may not qualify if:

• Self-reported acute psychiatric illness

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Neonatologie, Inselspital

Bern, Switzerland

RECRUITING

MeSH Terms

Conditions

Premature Birth; Burnout, Psychological

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• André Kidszun, Professor

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Central Study Contacts

Sophie E Jaisli, MD

CONTACT

031 632 21 11; sophie.jaisli@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 20, 2025
• Study Start: January 22, 2024
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

CH (1)