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Stress, PsychologicalNCT03017469

Achieving Resilience in Acute Care Nurses (ARISE).

A study testing ARISE in people with Stress, Psychological and Compassion Fatigue, run by Unity Health Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives, which can lead to adverse personal and professional outcomes. While workplace stress cannot be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease fatigue. Read more about this study

Who is it for?
Any age
Conditions the study is for
Stress, Psychological, Compassion Fatigue
What is being tested?
ARISE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteCanada
Study dates
21 Feb 2017to 15 Oct 2017
Phase
Interventional
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Nurse in the medical-surgical and trauma-neurosurgical intensive care units (MSICU and TNICU) and the medical/surgical floor (9CCN),
  • full-time or part-time employment status,
  • approval of clinical leader manager (CLM),
  • receipt of written informed consent.

Who cannot join

  • casual employment status
  • inability to attend intervention days

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

Other trials in Canada

About this study

Official title: Achieving Resilience in Acute Care Nurses (ARISE): A Randomized Controlled Trial of a Multi-component Intervention for Nurses in Critical Care and Trauma.

Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives, which can lead to adverse personal and professional outcomes. While workplace stress cannot be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease fatigue. Organizational employee health, wellness, and assistance programs are all intentioned to provide this type of support; however, nurses often lack awareness of options and opportunities, and access can be a challenge. The purpose of the proposed study is to assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance resilience and promote awareness of organizational resources for health, wellness, and employee assistance. We will evaluate the impact of participation in ARISE on resilience and other outcomes in nurses in critical care and trauma settings. As a Best Practice Spotlight Organization designated by the Registered Nurses Association of Ontario (RNAO), this project will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse Fatigue in Health Care.

Being tested
ARISE
Keywords
Resilience, Workplace Stress, Occupational Fatigue, Compassion Fatigue, Peer Support, Self-Care, Employee Assistance
Medical subject headings
Stress, Psychological, Compassion Fatigue, Occupational Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARISEOther

    1. Full day (7.5 hours) workshop consisting of a resilience-focused seminar facilitated by our Employee Assistance Provider (EAP) [Shepell], an introduction to hospital based resources including EAP and health and wellness offerings, and an introduction to self-care and self-care techniques including yoga and stretches, stress relief using the senses and mindfulness
    2. Half day (3.75 hours) workshop focusing on the following self-care techniques: mindfulness, yoga and stretching, and creative and reflective reading and writing
    3. Peer support through social media engagement (closed Facebook group) for 3 months post-intervention participation
    4. Five online, instructor-guided mindfulness sessions (Zoom)
Study groups in NCT03017469
Study groupRoleWhat they receive
ARISE InterventionExperimentalNurses who participate in the 1.5 day ARISE Intervention
Receives: Other: ARISE
Control GroupNo interventionNurses who do not participate in the ARISE Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Connor Davidson Resilience Scale (CD-RISC)

    Measured: 1 month post intervention

Secondary outcomes (13)

  1. Connor Davidson Resilience Scale (CD-RISC)

    Measured: 3 months post intervention

  2. Occupational fatigue and recovery (OFER) scale

    Acute fatigue and inter-shift recovery scales only

    Measured: 1 month post intervention

  3. Occupational fatigue and recovery (OFER) scale

    Acute fatigue and inter-shift recovery scales only

    Measured: 3 months post intervention

  4. Professional Quality of Life (ProQOL5) scale

    Measured: 1 month post intervention

  5. Professional Quality of Life (ProQOL5) scale

    Measured: 3 months post intervention

  6. Perceived Stress Scale (PSS)

    Measured: 1 month post intervention

  7. Perceived Stress Scale (PSS)

    Measured: 3 months post intervention

  8. Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).

    Measured: 1 month post intervention

  9. Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).

    Measured: 3 months post intervention

  10. Mindfulness Attention Awareness Scale (MASS)

    Measured: 1 month post intervention

  11. Mindfulness Attention Awareness Scale (MASS)

    Mindfulness attention awareness will be measured using the Mindfulness Attention Awareness Scale (MASS).

    Measured: 3 months post intervention

  12. Program Evaluation Outcomes for ARISE participants

    For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.

    Measured: 1 month post intervention

  13. Program Evaluation Outcomes for ARISE participants

    For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.

    Measured: 3 months post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2017 (estimated)
  2. Study start21 Feb 2017
  3. Primary completion31 May 2017
  4. Study completion15 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03017469
Sponsor's protocol ID
SMH30Dec2016
Status last verified
Apr 2018
First submitted
9 Jan 2017
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Aiken LH, Clarke SP, Sloane DM; International Hospital Outcomes Research Consortium. Hospital staffing, organization, and quality of care: cross-national findings. Int J Qual Health Care. 2002 Feb;14(1):5-13. doi: 10.1093/intqhc/14.1.5.

    PubMed 11871630

  • Akgum S, Al-Assaf AF, & Bakar C. Reducing Burnout among Hospital Professionals. Journal of Employee Assistance, 3:15-17, 2008.

  • Alexander GK, Rollins K, Walker D, Wong L, Pennings J. Yoga for Self-Care and Burnout Prevention Among Nurses. Workplace Health Saf. 2015 Oct;63(10):462-70; quiz 471. doi: 10.1177/2165079915596102.

    PubMed 26419795

  • Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

    PubMed 12703651

  • Campbell-Sills L, Stein MB. Psychometric analysis and refinement of the Connor-davidson Resilience Scale (CD-RISC): Validation of a 10-item measure of resilience. J Trauma Stress. 2007 Dec;20(6):1019-28. doi: 10.1002/jts.20271.

    PubMed 18157881

  • Peter E, Storch JL; Canadian Nurses Association. The CNA code of ethics for registered nurses. Nurs Leadersh (Tor Ont). 2008;21(2):28-33. doi: 10.12927/cjnl.2008.19872. No abstract available.

    PubMed 18536542

  • Casella E, Mills J, Usher K. Social media and nursing practice: changing the balance between the social and technical aspects of work. Collegian. 2014;21(2):121-6. doi: 10.1016/j.colegn.2014.03.005.

    PubMed 25109210

  • Chana N, Kennedy P, Chessell ZJ. Nursing staffs' emotional well-being and caring behaviours. J Clin Nurs. 2015 Oct;24(19-20):2835-48. doi: 10.1111/jocn.12891. Epub 2015 Jul 16.

    PubMed 26178012

  • Charney DS. Psychobiological mechanisms of resilience and vulnerability: implications for successful adaptation to extreme stress. Am J Psychiatry. 2004 Feb;161(2):195-216. doi: 10.1176/appi.ajp.161.2.195.

    PubMed 14754765

  • Coetzee SK, Klopper HC. Compassion fatigue within nursing practice: a concept analysis. Nurs Health Sci. 2010 Jun;12(2):235-43. doi: 10.1111/j.1442-2018.2010.00526.x.

    PubMed 20602697

  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113.

    PubMed 12964174

  • Craigie M, Slatyer S, Hegney DG, Osseiran-Moisson R, Gentry E, Davis S., . . . Rees C. A Pilot Evaluation of a Mindful Self-care and Resiliency (MSCR) Intervention for Nurses. Mindfulness, 7(3), 764-774, 2016. doi:10.1007/s12671-016-0516-x

  • Deible S, Fioravanti M, Tarantino B, Cohen S. Implementation of an integrative coping and resiliency program for nurses. Glob Adv Health Med. 2015 Jan;4(1):28-33. doi: 10.7453/gahmj.2014.057.

    PubMed 25694849

  • Dolan G, Strodl E, Hamernik E. Why renal nurses cope so well with their workplace stressors. J Ren Care. 2012 Dec;38(4):222-32. doi: 10.1111/j.1755-6686.2012.00319.x. Epub 2012 Aug 30.

    PubMed 22934929

  • Drury V, Craigie M, Francis K, Aoun S, Hegney DG. Compassion satisfaction, compassion fatigue, anxiety, depression and stress in registered nurses in Australia: phase 2 results. J Nurs Manag. 2014 May;22(4):519-31. doi: 10.1111/jonm.12168.

    PubMed 24926496

Questions about this trial

What is this clinical trial studying?

A study testing ARISE in people with Stress, Psychological and Compassion Fatigue, run by Unity Health Toronto at 1 site in Canada.

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 2 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 17 Apr 2018. 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 Canada. 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?

Connor Davidson Resilience Scale (CD-RISC) (time frame: 1 month post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03017469, which also lists 62 linked publications.

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 17 Apr 2018.

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