Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000798369
Ethics application status
Approved
Date submitted
22/05/2017
Date registered
31/05/2017
Date last updated
13/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Caring for HEalthy Engaged Resilient staff: A wellness training program for emergency department nurses
Scientific title
Caring for HEalthy Engaged Resilient staff: Effect of a wellness training program on stress in emergency department nurses
Secondary ID [1] 292013 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CHEER: Caring for HEalthy Engaged Resilient staff
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 303399 0
Coping 303400 0
Condition category
Condition code
Alternative and Complementary Medicine 302812 302812 0 0
Spiritual care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Those randomised to the intervention group will receive a face-to-face self-care intervention program designed and supervised by an accredited clinical psychologist with over 10 years of experience. Participants will be offered one of two weekly hospital based sessions of approximately 1 hour duration for 5 weeks (10 participants should be in each of the sessions) with a home program.
Sessions will cover the following topics;

Session 1
Phenomenology of Stress
How people cope – Support & Self Care
Self Care: 3 systems (Lifestyle, Physical (Body), Mental (Mind))
Lifestyle System: Sleep, Diet, Exercise, Fun
Principle of 5% change
Introduction to cyclic breathing – bridge to Session 2
Homework for session 1: Lifestyle audit, practice cyclic breathing

Session 2
Review Homework – Discussion
Physical System
Biological basis of arousal
Relaxation Training: overview, principles, goal (short and long techniques)
Skills training: cyclic breathing (review), Progressive Muscle Relaxation (PMR), Visualisation)
Homework for session 2: Progressive muscle relaxation, Visualisation

Session 3
Review Homework – Discussion
Mental System: Can’t stop thoughts, change how respond, shift focus of attention (Distraction), challenge (Cognitive Therapy), observe (Mindfulness)
Mindfulness: Definition
Skills Training - “mindfulness of the breath”
Homework for session 3: Practice – “mindfulness of the breath”


Session 4
Review Homework – Discussion
Mindfulness continued
Skills Training: “leaves on a stream”, mindful eating,
Homework for session 4: practice “leaves on a stream”, mindful eating

Session 5
Review Homework – Discussion
Cognitive Therapy: Overview, principles, ABC model
Discussion of process (techniques)
Discuss and work through brief examples


The sessions will be conducted in the ED conference room between the hours of 2pm and 3pm two afternoons per week. This time has been selected as it should minimise impact on clinical care and will also allow for completion of the program as part of work hours rather than in addition to current work schedule of already busy staff.
Intervention code [1] 298143 0
Lifestyle
Intervention code [2] 298145 0
Treatment: Other
Comparator / control treatment
Control treatment = the control group will be placed on a wait list to commence the program 3 months following completion of the study
Control group
Active

Outcomes
Primary outcome [1] 302195 0
Stress will be measured using the Depression, Anxiety and Stress Scale-21
Timepoint [1] 302195 0
7 Weeks and 3 Months post intervention commencement
Secondary outcome [1] 335148 0
Professional Quality of Life will be measured using the Professional Quality of Life Scale, version 5 (Pro-QOL-5)
Timepoint [1] 335148 0
7 Weeks and 3 Months post intervention commencement
Secondary outcome [2] 335149 0
Program Attendance (self reported)
Timepoint [2] 335149 0
7 Weeks post intervention commencement
Secondary outcome [3] 335151 0
Work engagement will be measured using the Utrecht Work Engagement Scale (UWES)
Timepoint [3] 335151 0
7 Weeks and 3 Months post intervention commencement

Eligibility
Key inclusion criteria
Nurse currently rostered to work in the RBWH DEM
Able to attend program
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Regular meditation practice within the past 6 month period (greater than or equal to 1 session per week)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An online randomisation procedure will be co-ordinated centrally by the research assistant using REDCap. By the end of accrual, it is planned to have approximately equal balance in each of the study groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use blocked randomization to form the allocation list for the two comparison groups. We will use a computer random number generator to select random permuted blocks and an equal allocation ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All analysis will be carried out on an intention-to-treat basis. Participant characteristics will be summarised and compared using means and standard deviations. Differences in outcomes will be evaluated using contingency tables and chi-square test for proportions; differences in continuous variables between the two groups will be evaluated using student’s t-test or an appropriate non-parametric test if the data does not conform to assumptions of normality. Repeated measures analysis will be used for evaluating changes in depression, anxiety and stress at 7 weeks and 3 months.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2017
Actual
Date of last participant enrolment
Anticipated
30/10/2017
Actual
Date of last data collection
Anticipated
14/02/2018
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8077 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 16129 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 16130 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 296538 0
Self funded/Unfunded
Name [1] 296538 0
This study is unfunded
Country [1] 296538 0
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butter field Street
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 295493 0
University
Name [1] 295493 0
Queensland University of Technology
Address [1] 295493 0
Cnr Musk and Victoria Park Road
Kelvin Grove QLD 4059
Country [1] 295493 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297758 0
Royal Brisbane and Women's Hospital
Ethics committee address [1] 297758 0
Ethics committee country [1] 297758 0
Australia
Date submitted for ethics approval [1] 297758 0
29/05/2017
Approval date [1] 297758 0
30/06/2017
Ethics approval number [1] 297758 0
HREC/17/QRBW/298

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75026 0
Ms Carol Jeffers
Address 75026 0
C/O Department of Emergency Medicine
Ground Floor, James Mayne Building
Butterfield Street
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 75026 0
Australia
Phone 75026 0
+61 7 3646 7002
Fax 75026 0
Email 75026 0
Carol.Jeffers@health.qld.gov.au
Contact person for public queries
Name 75027 0
James Hughes
Address 75027 0
C/O Department of Emergency Medicine
Ground Floor, James Mayne Building
Butterfield Street
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 75027 0
Australia
Phone 75027 0
+61 7 3646 4078
Fax 75027 0
Email 75027 0
James.Hughes@health.qld.gov.au
Contact person for scientific queries
Name 75028 0
James Hughes
Address 75028 0
C/O Department of Emergency Medicine
Ground Floor, James Mayne Building
Butterfield Street
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country 75028 0
Australia
Phone 75028 0
+61 7 3646 4078
Fax 75028 0
Email 75028 0
James.Hughes@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.