Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-04-13 @ 8:42 PM
Study NCT ID:
NCT04261751
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2020-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Moral Injury Symptom Scale/Moral Injury Outcome Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013315', 'term': 'Stress, Psychological'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 483}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-05', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-06', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Moral Injury', 'timeFrame': '1 Day', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Spiritual Wholeness', 'timeFrame': '1 Day', 'description': 'measured by Spiritual Wholeness Screening 4 items (yes/no)'}, {'measure': 'Social involvement/Social Support', 'timeFrame': '1 Day', 'description': 'measured by 1 social support/social involvement item'}, {'measure': 'Depression', 'timeFrame': '1 day', 'description': 'measured by the PhQ-9 Depression scale (9 items)'}, {'measure': 'Burnout', 'timeFrame': '1 Day', 'description': 'measured by Stanford Professional Fulfillment Index (16 items), and the MBI (22 items)'}, {'measure': 'Anxiety', 'timeFrame': '1 Day', 'description': 'measured by GAD-7 (7 items)'}, {'measure': 'Spiritual Well Being', 'timeFrame': '1 Day', 'description': 'measured by FACIT-SP (12 items)'}, {'measure': 'Moral injury', 'timeFrame': '1 Day', 'description': 'measured by the Moral Injury Events Scale (9 items) and the Expressions of Moral Injury Scale (17 items)'}, {'measure': 'PTSD', 'timeFrame': '1 Day', 'description': 'measured by PCL-5 (20 items)'}, {'measure': 'Post-traumatic growth', 'timeFrame': '1 Day', 'description': 'measured by Post-Traumatic Growth Inventory (21 items0'}, {'measure': 'Nurse Job Satisfaction', 'timeFrame': '1 Day', 'description': 'measured by the Nurse Job Satisfaction Scale (10 items)'}, {'measure': 'Satisfaction with care/time demands', 'timeFrame': '1 Day', 'description': 'measured by 1 item'}, {'measure': 'Prevalence of aggression', 'timeFrame': '1 Day', 'description': 'measured by Perception of Prevalence of Aggression Scale (adapted) 11 items'}, {'measure': 'Discrimination', 'timeFrame': '1 Day', 'description': 'measured by Everyday Discrimination Scale (10 items)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moral Injury', 'Anxiety', 'Depression', 'Burn-Out']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Licensed nurses at identified hospital within the state of Florida', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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\n2. Access to computer or mobile device to complete the survey\n3. Ability to read and understand English\n\nExclusion Criteria:\n\n1\\. Any employee at identified hospitals who is not a licensed nurse'}, 'identificationModule': {'nctId': 'NCT04261751', 'acronym': 'MISS MIOS', 'briefTitle': 'Moral Injury Symptom Scale/Moral Injury Outcome Scale', 'organization': {'class': 'OTHER', 'fullName': 'AdventHealth'}, 'officialTitle': 'Validation of the Moral Injury Symptom Scale Clinician Version Short Form and Moral Injury Outcome Scale in Nurses', 'orgStudyIdInfo': {'id': '1497904'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nurses', 'description': 'Nurses will be taking the Clinician Questionnaire electronically.', 'interventionNames': ['Other: Clinician Questionnaire']}], 'interventions': [{'name': 'Clinician Questionnaire', 'type': 'OTHER', 'description': 'Nurses will take the Clinician Questionnaire electronically', 'armGroupLabels': ['Nurses']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Hong Tao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AdventHealth'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AdventHealth', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}