- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04987697
A Pilot Study of RISE for Nurse Managers
25. februar 2022 oppdatert av: AdventHealth
A Pilot Study of RISE (Resilience, Insight, Self-Compassion, Empowerment) for Nurse Managers
The purpose of this study is to determine whether RISE for Nurse Managers has a significant impact on nurse managers' post-traumatic growth, resilience, insight, self-compassion, and empowerment, as well as mental well-being, in their personal lives and their working environment.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Florida
-
Orlando, Florida, Forente stater, 32804
- AdventHealth Orlando
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adult ≥ 18 years old
- Licensed as an RN
- Nurse manager employed by AdventHealth in a hospital-based setting at the Altamonte Springs, Apopka, Carrollwood, Celebration, Connerton, Dade City, Daytona Beach, DeLand, East Orlando, Fish Memorial, Heart of Florida, Kissimmee, Lake Placid, Lake Wales, New Smyrna Beach, North Pinellas, Ocala, Orlando, Palm Coast, Sebring, Tampa, Waterman, Wauchula, Wesley Chapel, Winter Garden, Winter Park, or Zephyrhills campus
- Able to speak, read, and understand English fluently
- Able to provide informed consent
- Willing and able to comply with all study procedures and requirements for the duration of the study
Exclusion Criteria:
1. Employed as a direct care nurse or in another level of nursing leadership (i.e., assistant nurse manager, director of nursing, executive leader)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Counseling and Surveys
nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC).
|
nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC).
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Posttraumatic Growth Inventory
Tidsramme: Change from Baseline to 6 months
|
21 item questionnaire with a scale of 0-5, with 0 meaning I did not experience this change as a result of my crisis to 5 meaning I experienced this change to a very great degree as a result of my crisis
|
Change from Baseline to 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Brief Cope
Tidsramme: Change from Baseline to 6 months
|
28 item questionnaire with a scale of 1-4, with 1 meaning I haven't been doing this at all; and 4 meaning I've been doing this a lot
|
Change from Baseline to 6 months
|
|
Brief Index of Affective Job Satisfaction
Tidsramme: Change from Baseline to 6 months
|
4 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree
|
Change from Baseline to 6 months
|
|
Brief Resilience Scale
Tidsramme: Change from Baseline to 6 months
|
6 item questionnaire with a scale of 1-5, with 1 meaning strongly disagree; and 5 meaning strongly agree
|
Change from Baseline to 6 months
|
|
Psychological Empowerment Instrument
Tidsramme: Change from Baseline to 6 months
|
12 item questionnaire with a scale of A-G, with A meaning very strongly disagree; and G meaning very strongly agree
|
Change from Baseline to 6 months
|
|
Perceived Stress Scale
Tidsramme: Change from Baseline to 6 months
|
10 item questionnaire with a scale of 0-4, with 0 meaning never; and 4 meaning very often
|
Change from Baseline to 6 months
|
|
Maslach Burnout Inventory General Survey
Tidsramme: Change from Baseline to 6 months
|
16 item questionnaire with a scale of 0-6 with 0 meaning never; and 6 meaning everyday
|
Change from Baseline to 6 months
|
|
Self-Compassion Scale - Short Form
Tidsramme: Change from Baseline to 6 months
|
12 item questionnaire with a scale of 1-5, with 1 meaning almost never; and 5 meaning almost always
|
Change from Baseline to 6 months
|
|
Self-Reflection and Insight Scale
Tidsramme: Change from Baseline to 6 months
|
20 item questionnaire with a scale of 1-6; with 1 meaning strongly disagree; and 6 meaning strongly agree
|
Change from Baseline to 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
- Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.
- Carver CS. You want to measure coping but your protocol's too long: consider the brief COPE. Int J Behav Med. 1997;4(1):92-100. doi: 10.1207/s15327558ijbm0401_6.
- Kath LM, Stichler JF, Ehrhart MG. Moderators of the negative outcomes of nurse manager stress. J Nurs Adm. 2012 Apr;42(4):215-21. doi: 10.1097/NNA.0b013e31824ccd25.
- Kath LM, Stichler JF, Ehrhart MG, Sievers A. Predictors of nurse manager stress: a dominance analysis of potential work environment stressors. Int J Nurs Stud. 2013 Nov;50(11):1474-80. doi: 10.1016/j.ijnurstu.2013.02.011. Epub 2013 Mar 21.
- Labrague LJ, McEnroe-Petitte DM, Leocadio MC, Van Bogaert P, Cummings GG. Stress and ways of coping among nurse managers: An integrative review. J Clin Nurs. 2018 Apr;27(7-8):1346-1359. doi: 10.1111/jocn.14165. Epub 2018 Jan 24.
- Lee H, Cummings GG. Factors influencing job satisfaction of front line nurse managers: a systematic review. J Nurs Manag. 2008 Oct;16(7):768-83. doi: 10.1111/j.1365-2834.2008.00879.x.
- Grant AM, Franklin J, Langford P. The Self-Reflection and Insight Scale: A new measure of private self-consciousness. Social Behavior and Personality. 2002; 30(8): 821-836.
- Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005; 4(4): 287-291.
- Maslach C, Jackson SE, & Leiter MP. (1996). Maslach Burnout Inventory manual (3rd ed.). Palo Alto, CA: Consulting Psychologists Press.
- Shirey MR, McDaniel AM, Ebright PR, Fisher ML, Doebbeling BN. Understanding nurse manager stress and work complexity: factors that make a difference. J Nurs Adm. 2010 Feb;40(2):82-91. doi: 10.1097/NNA.0b013e3181cb9f88.
- Spreitzer GM. Psychological empowerment in the workplace: Dimensions, measurement, and validation. Academy of Management Journal. 1995; 38(5):1442-1465.
- Steege LM, Pinekenstein BJ, Arsenault Knudsen E, Rainbow JG. Exploring nurse leader fatigue: a mixed methods study. J Nurs Manag. 2017 May;25(4):276-286. doi: 10.1111/jonm.12464. Epub 2017 Feb 27.
- Thompson ER & Phua FTT. A Brief Index of Affective Job Satisfaction. Group & Organization Management. 2012; 37(3): 275-307.
- Warshawsky NE, Havens DS. Nurse manager job satisfaction and intent to leave. Nurs Econ. 2014 Jan-Feb;32(1):32-9.
- Sawyer AT, McManus K, Bailey AK. A mixed-methods pilot study of a psychoeducational group programme for nurse managers during the COVID-19 pandemic. J Nurs Manag. 2022 Nov;30(8):4126-4137. doi: 10.1111/jonm.13881. Epub 2022 Nov 13.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
13. april 2021
Primær fullføring (Faktiske)
31. desember 2021
Studiet fullført (Faktiske)
31. desember 2021
Datoer for studieregistrering
Først innsendt
3. mars 2020
Først innsendt som oppfylte QC-kriteriene
28. juli 2021
Først lagt ut (Faktiske)
3. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
28. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. februar 2022
Sist bekreftet
1. februar 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1504917
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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