Moral InjuryMISS MIOSNCT04261751
Moral Injury Symptom Scale/Moral Injury Outcome Scale
An observational study of Moral Injury and Anxiety, run by AdventHealth at 1 site in United States.
Trial summary
The purpose of this research is to validate the moral injury symptom scale clinician version short form and the Moral Injury Outcome Scale in nurses. Participants will be recruited in accordance with AdventHealth Policy # 400.120: Selection and Enrollment of AdventHealth Employees, Physicians, and Volunteers for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Moral Injury, Anxiety, Depression
- What is being tested?
- Clinician Questionnaire
- How many people
- 483 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 7 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Licensed nurses at identified hospital within the state of Florida
Who may be able to join
- Currently working as a registered nurse (Licensed Practical Nurse, Registered Nurse, Assistant Nurse Manager, Nurse Manager, Nurse Educator) at identified hospital within the state of Florida
- Access to computer or mobile device to complete the survey
- Ability to read and understand English
Who cannot join
- 1. Any employee at identified hospitals who is not a licensed nurse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of the Moral Injury Symptom Scale Clinician Version Short Form and Moral Injury Outcome Scale in Nurses
The purpose of this research is to validate the moral injury symptom scale clinician version short form and the Moral Injury Outcome Scale in nurses. Participants will be recruited in accordance with AdventHealth Policy # 400.120: Selection and Enrollment of AdventHealth Employees, Physicians, and Volunteers for research Studies. Employee participants will be assured participation in this study will not affect performance evaluation or employment-related decisions by peers or supervisors. No employees will be recruited by a direct supervisor. Recruitment of potential employees as participants will occur without coercion by the Principal Investigator (PI), by bulletin board advertisements, or through a third party unassociated in a power/supervisory relationship with the employee (i.e., researchers from Center for Whole-Person Research).
- Conditions
- Moral Injury, Anxiety, Depression, Burn-Out
- Being tested
- Clinician Questionnaire
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician QuestionnaireOther
Nurses will take the Clinician Questionnaire electronically
| Study group | Role | What they receive |
|---|---|---|
| Nurses | Nurses will be taking the Clinician Questionnaire electronically. Receives: Other: Clinician Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moral Injury
measured by the Moral Injury Outcome Scale \& functional outcomes (23 items), and the Moral Injury Symptom Scale - Clinician Version - Short Form (MISS-CV-SF) 11 items. The scale is 10 - 100 with the higher number being worse.
Measured: 1 Day
Secondary outcomes (13)
Spiritual Wholeness
measured by Spiritual Wholeness Screening 4 items (yes/no)
Measured: 1 Day
Social involvement/Social Support
measured by 1 social support/social involvement item
Measured: 1 Day
Depression
measured by the PhQ-9 Depression scale (9 items)
Measured: 1 day
Burnout
measured by Stanford Professional Fulfillment Index (16 items), and the MBI (22 items)
Measured: 1 Day
Anxiety
measured by GAD-7 (7 items)
Measured: 1 Day
Spiritual Well Being
measured by FACIT-SP (12 items)
Measured: 1 Day
Moral injury
measured by the Moral Injury Events Scale (9 items) and the Expressions of Moral Injury Scale (17 items)
Measured: 1 Day
PTSD
measured by PCL-5 (20 items)
Measured: 1 Day
Post-traumatic growth
measured by Post-Traumatic Growth Inventory (21 items0
Measured: 1 Day
Nurse Job Satisfaction
measured by the Nurse Job Satisfaction Scale (10 items)
Measured: 1 Day
Satisfaction with care/time demands
measured by 1 item
Measured: 1 Day
Prevalence of aggression
measured by Perception of Prevalence of Aggression Scale (adapted) 11 items
Measured: 1 Day
Discrimination
measured by Everyday Discrimination Scale (10 items)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Nov 2019
- Primary completion7 Feb 2023
- Study completion7 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moral InjuryStudies of the same condition, open and under way.
- 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
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Tao, PhD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261751
- Sponsor's protocol ID
- 1497904
- Acronym
- MISS MIOS
- Status last verified
- Oct 2023
- First submitted
- 6 Feb 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Moral Injury Symptom Scale Clinician Version Short Form and Moral Injury Outcome Scale in Nurses
- ClinicalTrials.gov ID
- NCT04261751
- Acronym / sponsor ID
- MISS MIOS / 1497904
- Conditions
- Moral Injury, Anxiety, Depression, Burn-Out
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 7 Feb 2023 (actual)
- First posted
- 10 Feb 2020 (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.
The purpose of this research is to validate the moral injury symptom scale clinician version short form and the Moral Injury Outcome Scale in nurses. Participants will be recruited in accordance with AdventHealth Policy # 400.120: Selection and Enrollment of AdventHealth Employees, Physicians, and Volunteers for research Studies. Employee participants will be assured participation in this study will not affect performance evaluation or employment-related decisions by peers or supervisors. No employees will be recruited by a direct supervisor. Recruitment of potential employees as participants will occur without coercion by the Principal Investigator (PI), by bulletin board advertisements, or through a third party unassociated in a power/supervisory relationship with the employee (i.e., researchers from Center for Whole-Person Research).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurses | – | Other: Clinician QuestionnaireNurses will be taking the Clinician Questionnaire electronically. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Licensed nurses at identified hospital within the state of Florida
Key inclusion criteria (3 listed)
- Currently working as a registered nurse (Licensed Practical Nurse, Registered Nurse, Assistant Nurse Manager, Nurse Manager, Nurse Educator) at identified hospital within the state of Florida
- Access to computer or mobile device to complete the survey
- Ability to read and understand English
Key exclusion criteria (1 listed)
- 1. Any employee at identified hospitals who is not a licensed nurse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinician QuestionnaireNurses will take the Clinician Questionnaire electronically | Other | Nurses |
Primary outcome
Moral Injury
Time frame: 1 Day
measured by the Moral Injury Outcome Scale \& functional outcomes (23 items), and the Moral Injury Symptom Scale - Clinician Version - Short Form (MISS-CV-SF) 11 items. The scale is 10 - 100 with the higher number being worse.
13 secondary outcomes
Spiritual Wholeness
Time frame: 1 Day
Social involvement/Social Support
Time frame: 1 Day
Depression
Time frame: 1 day
Burnout
Time frame: 1 Day
Anxiety
Time frame: 1 Day
Spiritual Well Being
Time frame: 1 Day
Moral injury
Time frame: 1 Day
PTSD
Time frame: 1 Day
Post-traumatic growth
Time frame: 1 Day
Nurse Job Satisfaction
Time frame: 1 Day
Satisfaction with care/time demands
Time frame: 1 Day
Prevalence of aggression
Time frame: 1 Day
Discrimination
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hong Tao, PhD principal investigator
AdventHealth
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 Injury and Anxiety, run by AdventHealth at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 6 Oct 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moral Injury (time frame: 1 Day). 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 6 Oct 2023.