Wang 2015.
| Methods | Study design: RCT Country: Taiwan Total number: 80 |
|
| Participants | Population: people with malignant ascites from gastroenterology and oncology units, aged ≥ 18 years; clinically diagnosed stage Ⅳ cancer; clinically diagnosed malignant ascites; able to speak Mandarin or Taiwanese; obtained medical clearance from an attending physician to participate in the study; consent to participate, which was witnessed by a family member Setting: medical centre in northern Taiwan Mean age: 59.1 years |
|
| Interventions | Intervention: 15‐minute gentle abdominal massage, using straight rubbing, point rubbing, and kneading, administered twice daily for 3 days Comparison: twice‐daily 15‐minute social interaction contact with the same nurse Country of training: not described Years in practice: 8 hours (nurse practitioner) |
|
| Outcomes | Outcome measures at baseline and then follow‐up measurement after: in the morning for 4 consecutive days from pre‐ to post‐test
|
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned using random allocation software. However, participants at the same room were assigned to the same study group to avoid interactions between the intervention and control group" |
| Allocation concealment (selection bias) | Unclear risk | Used random allocation software. However, participants at the same room assigned to the same study group to avoid interactions between the intervention and control group |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Performed the same outcome assessment in both groups Quote: "A blinded outcome assessor measured body weight and collected self‐report data on malignant ascites symptoms from both groups each morning before breakfast (between 7 and 8 a.m.) over the 4 consecutive days from pre‐ to post‐test" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "all 80 participants completed the study" |
| Selective reporting (reporting bias) | Low risk | Quote: "the Edmonton Symptom Assessment System‐Ascites Modification (ESAS:AM) (Easson et al., 2007) was used to measure the severity of malignant ascites symptoms. The ESAS:AM has 11 items, each of which targets a specific ascites‐associated symptom. The participants were asked to indicate the severity of each symptom during the preceding 24 hours using an 11‐point (0 ‐ 10) numeric rating scale (NRS)" |
| Size | Unclear risk | n = 80 |
| Other bias | Unclear risk | Level of nausea was different at the baseline between groups (P value = 0.041) |