NCT06836323 The Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
| NCT ID | NCT06836323 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Moral Distress |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2025-08-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2024-01-22 with a primary completion date of 2025-08-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
André Kidszun, Professor
STUDY CHAIR
Insel Gruppe AG, University Hospital Bern
Frequently Asked Questions
Who can join the NCT06836323 clinical trial?
This trial is open to participants of all sexes, studying Moral Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06836323 currently recruiting?
Yes, NCT06836323 is actively recruiting participants. Contact the research team at sophie.jaisli@insel.ch for enrollment information.
Where is the NCT06836323 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06836323 clinical trial?
NCT06836323 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is André Kidszun, Professor at Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 800 participants.