Methods |
|
Participants |
|
Interventions |
|
Outcomes |
|
Notes |
See Table 8
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
"they were assigned, using a table of random numbers" |
Allocation concealment (selection bias) |
Unclear risk |
Not described. |
Blinding (performance bias and detection bias)
Subjective outcomes |
Unclear risk |
Study did not address subjective outcomes. |
Blinding (performance bias and detection bias)
Objective outcomes |
Low risk |
All patients wore headphones. "no hospital personnel were allowed to communicate with the patient. [...] scores were measured [...] by a blinded observer. To test observer blinding, the observer was asked whether he recognized the patient's group at any stage during the study period. [...] four patients were excluded because of failure in observer blinding after a technical problem." |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
"Four patients (three in the music and one in the control group) were excluded from the study because of technical problems related to the music player." Missing data not described. |
Selective reporting (reporting bias) |
Unclear risk |
Unknown if selective outcome reporting. |
Protection from contamination? |
Low risk |
Interventions administered on an individual basis. |