Wilkinson 2007.
Methods | Study design: RCT Country: UK Total: 288 randomised (aromatherapy with massage group n = 144, no‐massage group n = 144) |
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Participants | Population: people with cancer, referred to complementary therapy services with clinical anxiety or depression, or both Setting: recruited from 4 cancer centres and 1 hospice in England between September 1998 and May 2002 Mean age: 52.1 years |
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Interventions | Intervention: 4‐week course of weekly, 1‐hour sessions of aromatherapy massage Comparison: psychological support services as part of cancer care (usual supportive care) Country of training: not reported Years in practice: not reported |
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Outcomes | Outcome measures at randomisation, 6 weeks, and 10 weeks post‐randomisation Primary outcome
Secondary outcomes
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomly assigned using random number sequence, and balanced in randomly sized blocks" |
Allocation concealment (selection bias) | Low risk | Used numbered sealed opaque envelopes |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessed 6 same outcomes (SAI, CES‐D, EORTC‐pain, fatigue, nausea/vomiting, global QoL) at 6 weeks and 10 weeks post‐randomisation in both groups |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 67/288 lost to follow‐up Quote: "the data available at 6 and 10 weeks post randomisation were not representative of the complete sample of randomly assigned patients" |
Selective reporting (reporting bias) | Unclear risk | Quote: "along with missing questionnaires, the continuous secondary outcome measures were considered missing if fewer than half of the items of a factor were completed" |
Size | Low risk | n = 288 |
Other bias | Low risk | No other significant bias found |
BMT: bone marrow transplantation; DBP: diastolic blood pressure; ms: millisecond; n: number of participants; QoL: quality of life;
RCT: randomised controlled trial; SBP: systolic blood pressure.