Samouei 2015.
Study characteristics | ||
Methods |
Study design: RCT Study grouping: parallel group Unit of randomisation: not exactly specified (based on full text unclear if individual or cluster‐randomisation)Power (power & sample size calculation, level of power achieved): not specifiedImputation of missing data: not specified |
|
Participants |
Country: IranSetting: students of Isfahan University of Medical Sciences; training setting probably university (since training sessions held at same day as other university classes)Age: not specifiedSample size (randomised): not specifiedSex: not specifiedComorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified Population description: students of Isfahan University of Medical Sciences Method of recruitment: recruited from students of Isfahan University of Medical Sciences (Department of Management and Medical Informatics and Department of Rehabilitation Sciences); 5 study groups selected from majors of audiology, speech therapy, orthopaedics, physiotherapy, healthcare management, and medical librarianship; method of recruitment not specified Inclusion criteria: not specified Exclusion criteria: not specified Attrition (withdrawals and exclusions): not specified Reasons for missing data: not specified |
|
Interventions |
Intervention: mindfulness training (n = not specified)
Control: active control (n = not specified)
|
|
Outcomes |
Outcomes collected and reported:
Time points measured and reported: 1) pre‐intervention; 2) 3‐month follow‐up (i.e. 3 months after last session); only 2) reported Adverse events: not specified |
|
Notes | Contact with authors: We contacted the authors for the number of participants randomised to each group. We also asked if there were any missing data (e.g. withdrawals or exclusions) in the 2 groups, the number of participants analysed, respectively, and if the study used cluster randomisation, but received no response to 2 inquiries. Study start/end date: study conducted in 2013Funding source: financial support and sponsorship: nilDeclaration of interest: There are no conflicts of interest.Ethical approval needed/obtained for study: not specifiedComments by study authors: not relevantMiscellaneous outcomes by the review authors: not relevantCorrespondence: Miss Rahele Samouei, PhD Student of Health Management in Disasters; Social Determinants of Health Research Center, Isfahan University of Medical Sciences, Isfahan, Iran; Samouei@mail.mui.ac.ir | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Therefore, cluster sampling method was employed by simultaneous selection of five groups of students from two departments to four majors whom were then randomly divided to study and control groups." Judgement comment: insufficient information about random‐sequence generation to permit judgement of ‘Low risk’ or ‘High risk’; no information about comparability of groups in sociodemographic characteristics or outcome variables 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 | High risk | Judgement comment: blinding of participants and personnel probably not done (face‐to‐face intervention) and the outcome is likely to be influenced by lack of blinding |
Blinding of outcome assessment (detection bias) Subjective outcomes | High risk | Judgement comment: insufficient information about blinding of outcome assessment; but 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 | Unclear risk | Judgement comment: insufficient reporting of attrition/exclusions to permit judgement of ‘Low risk’ or ‘High risk’ (e.g. number randomised to each group not stated; unclear if there were any missing data and if missing data were imputed, for example; number of participants analysed in each group not specified) |
Selective reporting (reporting bias) | High risk | Judgement comment: no study protocol or trial registration available, but not all of the study’s prespecified outcomes have been reported (FFMQ values at post‐intervention not reported) |