Vadiraja 2009.
Methods | Randomised controlled trial | |
Participants | Women with diagnosed stage II‐III breast cancer undergoing radiotherapy during the study period Recruited from 2 comprehensive cancer care centres Mean age 47.2 years N = 88 |
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Interventions | • Integrated yoga programme (yoga postures, breathing techniques, relaxation with imagery, meditation), 6 weeks, 60 minutes at least 3 times a week (18–24 sessions in total) • Brief supportive therapy, 6 weeks, 15 minutes every 10 days (3–4 sessions in total) |
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Outcomes | Health‐related quality of life (European Organisation for Research in the Treatment of Cancer ‐ Quality of Life) at week 6
Anxiety (Hospital Anxiety and Depression Scale) at week 6
Depression (Hospital Anxiety and Depression Scale) at week 6 Fatigue (European Organisation for Research in the Treatment of Cancer ‐ Quality of Life) at week 6 Insomnia (European Organisation for Research in the Treatment of Cancer ‐ Quality of Life) at week 6 |
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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 | "[...] participants [...] were randomized, via computer‐generated random numbers, to receive yoga (n = 44) or supportive therapy (n = 44) before intervention (prior to radiotherapy)." |
Allocation concealment (selection bias) | Low risk | "Randomization was performed using opaque envelopes with group assignments. Personnel who had no part in the trial performed randomization. The envelopes were opened sequentially in the order of assignment during recruitment, with the names and registration numbers of the participants written on the covers. The order of randomization was verified with the hospital date of admission records for radiotherapy at study intervals to make sure that field personnel had not altered the sequence of randomization to suit the allocation of consenting participants into 2 study arms." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | "[...] it was not possible to mask the yoga intervention from the study participants." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information on blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5% dropout in yoga group and 25% dropout in control group |
Selective reporting (reporting bias) | High risk | No protocol available. Duplicate publications separately reported different outcomes of the same trial. Complete outcome measures were not disclosed. |
Other bias | Low risk | No hint of other bias |