Villani 2013.
Study characteristics | ||
Methods |
Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power sample size calculation, level of power achieved): power not specified; small sample size Imputation of missing data: not applicable since no dropouts or exclusions |
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Participants |
Country: Italy Setting: oncology hospitals Age: mean = 43 (SD = 8.80) years Sample size (randomised): 30 Sex: 30 women (oncology nurses) Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: all participants with cut‐off of stress corresponding to higher quartile (Italien normative data) measured by Mesure du Stress Psycholyque (MSP); received from authors (Villani 2018 [pers comm]): state anxiety (STAI): IG = 43.64 (8.03), CG = 44.00 (9.91) Population description: female oncology nurses with permanent status employed in 6 oncology hospitals in Milan, Italy Inclusion criteria: 1) being a current oncology nurse with a minimum of 5 years of experience in the oncology ward; 2) having a permanent status, to avoid sources of stress related to temporary employment; 3) having a cut‐off level of stress corresponding to the higher quartile (Italian normative data), measured using the MSP Questionnaire Exclusion criteria: not specified Attrition (withdrawals and exclusions): information received from authors (Villani 2018 [pers comm]): no dropouts or exclusions during the study (only 8 participants excluded before randomisation because they did not meet the inclusion criteria) Reasons for missing data: not applicable since no dropouts or exclusions |
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Interventions |
Intervention: Mobile Stress Inoculation Training (M‐SIT) (n = 15)
Control: attention control (n = 15)
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Outcomes |
Outcomes collected and reported:
Time points measured and reported: 1) pre‐intervention; 2) end of session 1 (only state anxiety); 3) end of session 2 (only state anxiety); 4) end of session 3 (only state anxiety); 5) end of session 4 (only state anxiety); 6) end of session 5 (only state anxiety); 7) end of session 6 (only state anxiety); 8) post‐intervention (after all 8 training sessions) Adverse events: not specified |
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Notes |
Contact with authors: We contacted the authors for the means and SDs for all outcomes at pre‐ and post‐intervention (after 8 sessions), the number of dropouts and the number of participants analysed in each group (Villani 2018 [pers comm]). Study start/end date: not specified Funding source: not specified Declaration of interest: not specified Ethical approval needed/obtained for study: not specified Comments by authors: not specified Miscellaneous outcomes by the review authors: information on attrition and values on state anxiety received from authors (Villani 2018 [pers comm]) Correspondence: Daniela Villani, PhD, Department of Psychology, Catholic University of Sacred Heart, Milan, Italy; daniela.villani@unicatt.it |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Participants were randomly allocated into two groups (15 participants for each condition)." Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; no information about comparability of groups at baseline or respective analysis |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: insufficient information about allocation concealment to permit judgement of ‘Low risk’ or ‘High risk’ |
Blinding of participants and personnel (performance bias) Subjective outcomes | Unclear risk | Judgement comment: self‐help intervention via mobile phones; insufficient information about blinding of participants and personnel to permit judgement of ‘Low risk’ or ‘High risk’ |
Blinding of outcome assessment (detection bias) Subjective outcomes | Unclear risk | Judgement comment: insufficient information about blinding of outcome assessment to permit judgement of ‘Low risk’ or ‘High risk’ |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Judgement comment: information received from authors: no dropout from 30 participants |
Selective reporting (reporting bias) | Low risk | Judgement comment: no study protocol available but it is clear that the published reports include all expected outcomes, including those that were prespecified (job content and perceived stress only assessed at pre‐intervention and no outcomes) |