Clinical trial NCT06836323: The Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
Official title: Exploring the Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moral Distress
Keywords: Neonatal intensive care
Preterm
Moral distress
Resilience
Burnout
Workload
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Highly specialized medical care is required to ensure the survival and healthy development of the many infants who are either born critically ill or prematurely.

Working in a neonatal intensive care unit (NICU) is particularly demanding. Neonatal care providers are faced with numerous medical, emotional and ethical challenges including emergencies and severe pathologies, highly stressed parents, infants hospitalized for months, suffering and death. In Swiss perinatal centers, more than 200 extremely premature infants die each year. In addition, in view of the persistent uncertainty of outcomes, decision making with parents can be extremely challenging. Parental values and beliefs may compete with the principles of the medical team.

Moral distress (MoD) is an increasingly recognized phenomenon that occurs when a person is prevented from taking an action that he or she believes to be morally right. It is thought that such situations are common in neonatal care and that MoD has serious negative consequences, including burnout and resignation. In many parts of the world, there is a significant gap in knowledge about the extent of MoD among neonatal care providers. Furthermore, the complex interplay between MoD and mental health outcomes remains largely unexplored. Improving the understanding of MoD and exploring its possible determinants are essential to effectively target and mitigate its negative effects.

This project aims to provide normative data on the extent of MoD among neonatal care providers in several third level German speaking hospitals in Switzerland. This project will further explore the interaction between MoD and burnout symptoms, as well as the role of possible protective and moderating factors, including moral resilience, psychological distress, perceived stress, and workload.

This study breaks new ground with new instruments and therefore has pilot character. In this study, quantitative and qualitative research methods will be used in the sense of a mixed methods approach. With this research approach, it is possible to obtain empirical data to inform relevant stakeholders, but also to obtain rich and narrowly focused data in words to achieve the aim of a better understanding MoD and of exploring the interplay between MoD, moral resilience and mental health outcomes. More specifically, the study uses classical empirical data collection, but also includes semi-structured interviews with neonatal care providers.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Self-reported acute psychiatric illness

Primary outcomes:
measure: Moral Distress
timeFrame: 1 year
Secondary outcomes:
measure: Secondary endpoints
timeFrame: 1 year
measure: Secondary endpoints
timeFrame: 1 year
measure: Secondary endpoints
timeFrame: 1 year
measure: Secondary endpoints
timeFrame: 1 year
measure: Secondary endpoints
timeFrame: 1 year
Other outcomes:
measure: Further outcomes
timeFrame: 1 year
measure: Further outcomes
timeFrame: 1 year
Locations:
city: Bern
country: Switzerland
facility: Neonatologie, Inselspital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: André Kidszun, Professor
role: STUDY_CHAIR
References: