Mirzaeirad 2019.
Study characteristics | ||
Methods |
Study design: RCT Study grouping: parallel group Unit of randomisation: individuals Power (power & sample size calculation, level of power achieved): according to a priori sample size calculation at least 34 persons required in each group according to similar studies Imputation of missing data: not specified |
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Participants |
Country: Iran
Setting: hospital (intervention performed in the place of hospital training courses)
Age: 42 (52.5%) < 31 years, 28 (35%) > 31 years
Sample size (randomised): 80 (after exclusions)
Sex: 66 women, 14 men
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: nurses Inclusion criteria: 1) undergraduates with at least 1 year of hospital experience and specialty areas (operating room, children and emergency); 2) lack of physical disabilities or mental stress; 3) failure to receive interventions or classes related to stress reduction during the past year in the workplace; 4) absence of severe stress and emotional crisis (e.g. death of first‐degree relatives during last year) Exclusion criteria: 1) participants stating that they had any disabling physical and psychological problems; 2) unwillingness to co‐operate or continue participating in the study Attrition (withdrawals and exclusions): 4 (IG = 2, CG = 2) Reasons for missing data: IG = lack of full participation in the workshop (n = 2); CG = change of location (n = 1), unwillingness to continue co‐operation (n = 1) |
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Interventions |
Intervention: resilience‐skills training (n = 40; after exclusions)
Control: not specified (n = 40; after exclusions) |
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Outcomes |
Outcomes collected and reported:
Time points measured and reported: 1) pre‐intervention; 2) post‐intervention; 3) 1‐month follow‐up (1 month post‐intervention) Adverse events: not specified |
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Notes |
Contact with authors: We contacted the authors for the number of participants randomised to each group and to ask for the means and SDs for the outcome of nursing stress in the 2 groups at each time point. We also asked for the treatment duration in weeks/months and whether the authors performed a per‐protocol analysis, but received no response to 2 inquiries. Study start/end date: not specified Funding source: not specified Declaration of interest: not specified Ethical approval needed/obtained for study: approved by Ethics Committee of the University of Social Welfare and Rehabilitation Sciences Comments by study authors: article is taken from the dissertation of Seiedeh Zahra Mirzaeirad at the University of Social Welfare and Rehabilitation Sciences (Moral Code 144.1394.REC.USWR.IR) Miscellaneous outcomes by the review authors: article in Persian (translated) Correspondence: Seiedeh Zahra Mirzaeirad; corresponding author: Narges Arsalani, Associate Professor, Department of Nursing, Faculty of Rehabilitation, University of Social Welfare and Rehabilitation Sciences, Tehran, Iran; nargesarsalani@gmail.com |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "The present study is quasi‐experimental. Participants included nurses working in hospitals in Golestan province who were randomly selected and randomly assigned to participate in the study." Quote: "ی گردد. یافته ها <b>در جدول 4 توزیع بر عالوه ، متغ یرهای نشان شناختی جمعیت م ی دهد که گروه دو به همگن توزیع با متغیرها سایر جنسیت متغیر از بغیر یافتند اختصاص شاهد و مداخله ( 15 / 1 < P</b> ) . جدول 3 نشان" ["In Table 2, in addition to the distribution of demographic variables, it is shown that except for gender, other variables were homogeneously distributed between the intervention and control group (p > .05)."] Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; RCT and verified baseline comparability of groups for sociodemographic characteristics (see Table 2; except for gender) and outcome variable nursing stress on the basis of analysis (see Table 3) |
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 | High risk | Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention) and the outcome is likely to be related to true outcome |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Judgement comment: insufficient information about blinding of outcome assessment; however, due to potential performance bias (no blinding of participants), the review authors judge that the participants' responses to questionnaires may be affected by the lack of blinding (i.e. knowledge and beliefs about intervention they received) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "پایان مداخله،۴۰ پرسشنامه تکمیل شده مورد بررسی قرار گرفت. " [At the end of the intervention, 40 completed questionnaires were evaluated.] Quote: " از این تعداد در گروه آزمون ۴ نفر به سبب عدم شرکت کامل در کارگاه آموزشی، در گروه شاهد یک نفر به علت تغییر محل خدمت و یک نفر به علت عدم تمایل به ادامه همکاردند. [Four participants were excluded, 2 from the study group due to lack of full participation in the workshop, one in the control group due to change of location and one due to unwillingness to continue cooperation.] Judgement comment: reasons for missing data likely to be related to true outcome (see reasons for exclusions in both groups); per‐protocol analysis |
Selective reporting (reporting bias) | Low risk | Judgement comment: no study protocol or trial registration available but it is clear that the published reports include all expected outcomes, including those that were prespecified |