Kovacic 2013.
Methods | Randomised controlled trial using Latin Square randomisations | |
Participants | Women with diagnosed stage I‐II breast cancer receiving multi‐modal therapy (surgery, radiotherapy, chemotherapy) Recruited from the Institute for Oncology Ljubljana Mean age not reported N = 32 |
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Interventions | • Yoga in Daily Life® System (yoga postures, breathing techniques, deep relaxation, progressive muscle relaxation, meditation), 1 week, once daily for 45 minutes combined with standard physiotherapy • Standard physiotherapy |
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Outcomes | Anxiety (Spielberger's State‐Trait Anxiety Inventory) at week 2 and week 5 | |
Notes | Duplicate publications separately reported different outcomes of the same trial. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "The Latin Square randomization method was used in the study. Stratifying factors were type of surgery, severity and stage of breast cancer, and socio‐demographic
characteristics (age, marital status, employment status, education). Baseline values between experimental and control group regarding stratifying factors were successfully equalized." "A randomization list was prepared by the independent statistician using the random permuted blocks. This technique has ensured that equal numbers of patients within each stratum were randomized to each intervention (restricted stratified randomization)." |
Allocation concealment (selection bias) | Low risk | No information on allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "[...] patient blinding was impossible [...]" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Outcome measures were obtained by blinded assessors [...]." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No information on attrition |
Selective reporting (reporting bias) | High risk | Duplicate publications separately reported different outcomes of the same trial. |
Other bias | Low risk | No hint of other bias |