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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01959750
Other study ID # CER 08-220 (NAC08-069)
Secondary ID
Status Completed
Phase N/A
First received September 23, 2013
Last updated October 9, 2013
Start date April 2009
Est. completion date September 2013

Study information

Verified date October 2013
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority Switzerland: Federal Office of Public Health
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date September 2013
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- all ICU caregivers rrom the University Hospital of Geneva

Exclusion Criteria:

- refusals

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
problem-based sessions
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

Locations

Country Name City State
Switzerland University Hopitals of Geneva Geneva

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Measurement of staff quitting their jobs 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 No
Primary Measurement of the changes in the levels of anxiety, depression, and burnout in nurses and nursing auxiliaries. 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. No
Secondary Composite measurement of the changes of ICU activity and absenteeism before, during, just after and six months after the intervention. 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). No
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