| Methods |
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Notes |
See Table 8
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Participants were randomly assigned [...] using sealed envelopes with a varied block size prepared by the statistician" |
| Allocation concealment (selection bias) |
Low risk |
"using sealed envelopes with a varied block size [...] The investigator was blind to the block size and could not anticipate group assignment" |
| Blinding (performance bias and detection bias)
Subjective outcomes |
High risk |
Participants aware of group allocation. |
| Blinding (performance bias and detection bias)
Objective outcomes |
Unclear risk |
Study did not address objective outcomes. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
"Although all patients who were enrolled completed the study, one participant in the music group was identified as an outliner for extreme pain and mild respiratory distress and was dropped from the analyses" |
| Selective reporting (reporting bias) |
Unclear risk |
Not known. |
| Protection from contamination? |
Low risk |
Interventions administered on an individual basis. |
