Moral DistressMoDNCT06836323
The Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
An observational study of Moral Distress, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Moral Distress
- How many people
- 800 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jan 2024to 4 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Self-reported acute psychiatric illness
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Neonatologie, Inselspital
Bern
André Kidszun, Professor, 031632111, andre.kidszun@insel.ch
About this study
Official title: Exploring the Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
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.
Read more
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.
Read the 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.
- Conditions
- Moral Distress
- Keywords
- Neonatal intensive care, Preterm, Moral distress, Resilience, Burnout, Workload
- Medical subject headings
- Premature Birth, Burnout, Psychological
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (5)
Secondary endpoints
Sum score of Wocial's Moral Distress Thermometer (MDT). The MDT is a rapid screening tool to detect MoD.
(Scale from 1 to 10, with higher values indicating more Moral Distress)
Measured: 1 year
Secondary endpoints
Sum score of the Maslach Burnout Inventory (MBI) - The MBI is a standardized measurement instrument for the assessment burnout syndrome.
(Scale from 0 to 6, 22 items, 3 factors: emotional exhaustion, depersonalization, personal accomplishment, higher score indicating higher degrees fo each factor, for exhaustion and depersonalization higher scores indicate higher burnout, for accomplishment higher scores indicate lower burnout)
Measured: 1 year
Secondary endpoints
Sum score of the Muir matches scale - The Muir matches scale is a visual scale that allows participants to point at one of eight matches to indicate how burnt out they feel. (number 8 indicating the highest level of burnout)
Measured: 1 year
Secondary endpoints
Differences in MDS-R site-specific. 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)
Measured: 1 year
Secondary endpoints
Differences in MBI site-specific. - The MBI is a standardized measurement instrument for the assessment burnout syndrome.
(Scale from 0 to 6, 22 items, 3 factors: emotional exhaustion, depersonalization, personal accomplishment, higher score indicating higher degrees fo each factor, for exhaustion and depersonalization higher scores indicate higher burnout, for accomplishment higher scores indicate lower burnout)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start22 Jan 2024
- Primary completion4 Aug 2025 (estimated)
- Study completion4 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moral DistressStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Kidszun, Professor, Study chair, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836323
- Sponsor's protocol ID
- 2023-01953
- Other IDs
- 2023
- Acronym
- MoD
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Interplay Between Moral Distress, Moral Resilience, and Mental Health Outcomes Among Neonatal Care Providers
- ClinicalTrials.gov ID
- NCT06836323
- Acronym / sponsor ID
- MoD / 2023-01953
- Conditions
- Moral Distress
- Keywords
- Neonatal intensive care, Preterm, Moral distress, Resilience, Burnout, Workload
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 4 Aug 2025 (estimated)
- Study completion
- 4 Aug 2025 (estimated)
- First posted
- 20 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Self-reported acute psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Moral Distress
Time frame: 1 year
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)
5 secondary outcomes
Secondary endpoints
Time frame: 1 year
Secondary endpoints
Time frame: 1 year
Secondary endpoints
Time frame: 1 year
Secondary endpoints
Time frame: 1 year
Secondary endpoints
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
André Kidszun, Professor study chair
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moral Distress, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie E Jaisli, MD (031 632 21 11, sophie.jaisli@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moral Distress (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.