- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01959750
Psychological Intervention on Burnout in ICU Caregivers
Psychological Intervention on Burnout in ICU Caregivers: a Randomised Controlled Study
ICU caregivers face up to a demanding job with a high level of technical skills, a stressful environment, and a heavy work load. They run a high risk of developing burnout that can impact on their welfare, performance, and patient care. Burnout favours absenteeism and staff quitting their jobs, whereas the shortage of ICU caregivers already started. No randomised controlled intervention aimed at reducing such distresses had been run until now.
This study allowed finding a new method of psychological support applicable in the special environment of ICU. Our findings suggest that psychologists specifically assigned to treat ICU caregivers might be beneficial on their burnout.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Geneva, Switzerland
- University Hopitals of Geneva
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- all ICU caregivers rrom the University Hospital of Geneva
Exclusion Criteria:
- refusals
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control Group
|
|
|
EXPERIMENTAL: Intervention Group
|
weekly sessions for small groups of caregivers, led by two psychologists acting as moderators and using a systemic approach, as suggested in other peer-support groups using a problem-based method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of the changes in the levels of anxiety, depression, and burnout in nurses and nursing auxiliaries.
Time Frame: At the beginning , at the end and 6 months after the end of the intervention.
|
Anxiety (HA) and depression (HD) were identified by the validated French version of the Hospital Anxiety and Depression Scale (HADS), which is composed of 14 items, self-rated using a 4-point Likert scale (0 to 3). The sub-scale scores of anxiety and depression range respectively from 0 to 7 (no distress), 8 to 10 (borderline), 11 to 15 (significant) and 16 to 21 (severe distress). Burnout was evaluated using the Maslach Burnout Inventory (MBI) in its Fontaine French version; it is composed of 22 questions on a 7-point Likert scale (0 to 6). This tool measures the 3 dimensions of burnout independently: emotional exhaustion, depersonalisation, and personal accomplishment. Scores of ≥ 27, ≥ 10, or ≤33 respectively for the 3 dimensions, can be a sign of burnout. A severe burnout can also be defined as the cumulated score of MBI of > -9. |
At the beginning , at the end and 6 months after the end of the intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite measurement of the changes of ICU activity and absenteeism before, during, just after and six months after the intervention.
Time Frame: 4 three-months time periods (cf. Description).
|
ICU activities and absenteeism were analysed during 4 three-month time periods, i.e. 3 months before [Before] (January to March 2009), 3 months during [During] (randomly picked out as September and November 2009, and January 2010), 3 months following the end of the intervention [After] (April to June 2010) and from 7 to 10 months after intervention [At 6 months] (November, December 2010 and January 2011).
Absenteeism was defined as the number of caregivers absent at least once per time period, independently of the duration of the absence.
|
4 three-months time periods (cf. Description).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of staff quitting their jobs
Time Frame: At the end of the intervention
|
We identified how many persons had quitted the ICU between the beginning and the end of the intervention (inclusion time).
|
At the end of the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Bara Ricou, Professor, University Hospitals of Geneva
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CER 08-220 (NAC08-069)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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