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. 2023 May 12;2023(5):CD002892. doi: 10.1002/14651858.CD002892.pub6

ElKhamali 2018.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Participants Baseline characteristics
Multimodel intervention

  • Age n(%) < 30, 31 to 40, > 41: 49 (49%), 45 (45%), 7 (7%)

  • Sex (N (% female)): 61 (60%)

  • Sample size: 101

  • Years of experience (mean ± SD): NR


Control (no intervention)

  • Age n(%) < 30, 31 to 40, > 41: 46 (47%), 43 (44%), 8 (8%)

  • Sex (N (% female)): 54 (56%)

  • Sample size : 97

  • Years of experience (mean ± SD): NR


Overall

  • Age n(%) < 30, 31 to 40, > 41: NR

  • Sex (N (% female)): NR

  • Sample size: NR

  • Years of experience (mean ± SD): NR


Included criteria: (1) actively working in an adult ICU, (2) held a registered nurse license, and (3) had at least 6 months’ work experience in the current ICU.
Excluded criteria: (1) current placement outside ICU, (2) on maternity or sick leave, (3) planning to leave ICU, or (4) already completed the simulation intervention prior to the beginning of the trial.
Pretreatment: the only major between‐group difference was in marital status (46% were single in the intervention group vs 62% in the control group).
Compliance rate: 100%
Response rate: 100%
Type of healthcare worker: nurses
Interventions Intervention characteristics
Multi‐model intervention

  • Type of the intervention: Intervention type 4. Combination of intervention type 1 to focus one’s attention on the experience of stress and 3 to focus on work‐related risk factors on an individual level.

  • Description of the intervention: The intervention was intended to reduce job strain prevalence by improving the ability of ICU nurses to cope with stressful situations and cope with some stressors related to work organisation or working conditions.

  • The number of sessions: five

  • Duration of each session on average: five whole working days

  • Duration of the entire intervention: two weeks

  • Duration of the entire intervention short vs long: short

  • Intervention deliverer: physicians and qualified nurses

  • Intervention form: Group


Control (no intervention)

  • Type of the intervention: NA

  • Description of the intervention: NA

  • The number of sessions: NA

  • Duration of each session on average: NA

  • Duration of the entire intervention: NA

  • Duration of the entire intervention short vs long: NA

  • Intervention deliverer: NA

  • Intervention form: NA
Outcomes Job stress questionnaire (JSQ) ‐ psychological demand

  • Outcome type: ContinuousOutcome


Job stress questionnaire (JSQ) ‐ decision latitude

  • Outcome type: Continuous Outcome


Job stress questionnaire (JSQ) ‐ Social support

  • Outcome type: Continuous Outcome


The Copenhagen Psychosocial Questionnaire ‐ (COPSOQ) ‐ stress

  • Outcome type: Continuous Outcome


The Copenhagen Psychosocial Questionnaire ‐ (COPSOQ) ‐ burnout

  • Outcome type: Continuous Outcome
Identification Sponsorship source: NR
Country: France
Setting: Hospital
Comments: NR
Authors name: Radia El Khamali
Institution: Assistance Publique‐Hôpitaux de Marseille, Hôpital Nord, Réanimation des Détresses Respiratoires et des Infections Sévères, Marseille, Franc
Email: laurent.papazian@ap‐hm.fr
Address: Laurent Papazian, MD, PhD, Médecine Intensive‐Réanimation, Hôpital Nord, Chemin des Bourrely, 13015 Marseille, France
Time period: 2016‐2019
Notes COPSOQ stress included in analysis 4.2
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Briefly, ICU nurses meeting the inclusion criteria were selected by lots drawn by the clinical research unit at the Assistance Publique‐Hôpitaux de Marseille, which was not involved with the ICU. At each planned session, the chief nurse provided the clinical research unit with a list of nurses to participate in the program (each nurse chose an identification number). The clinical research unit selected 2, 4, 6, 8, 10, or 12 nurses to participate in the trial. Half of the selected nurses (1, 2, 3, 4, 5, or 6) were randomized to the intervention group and the other half were randomized to the control group.
Allocation concealment (selection bias) Unclear risk Participants were randomly assigned using a computer‐generated randomization list (allocation ratio of 1:1) and a permuted block design (block size range, 4‐8). Participants from 1 to 3 ICUs were randomized to 1 of 2 equal‐sized groups: (1) the 5‐day intervention simulation training group or (2) the control group (nurses did not participate in simulation training but answered questionnaires).
Insufficient information to understand whether intervention allocations could have been foreseen in advance of, during, enrolment.
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants were not blinded. 
Blinding of outcome assessment (detection bias)
All outcomes High risk Participants were not blinded whereas outcomes are self‐reported.
Incomplete outcome data (attrition bias)
All outcomes Low risk Almost no loss to follow‐up, those lost reasons were reported
Selective reporting (reporting bias) High risk Registration protocol: https://clinicaltrials.gov/ct2/show/NCT02672072 Did not report on the outcomes of Maslach Burnout inventory
Other bias Low risk  No indication for other sources of bias.