| Methods |
|
| Participants |
|
| Interventions |
|
| Outcomes |
|
| Notes |
See Table 8
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Randomization was completed within categories of procedures [...] to ensure that the different types of procedures were distributed equally among the three study groups" Method of randomisation not described. |
| Allocation concealment (selection bias) |
Unclear risk |
Not described. |
| Blinding (performance bias and detection bias)
Subjective outcomes |
High risk |
Patients aware of group allocation. |
| Blinding (performance bias and detection bias)
Objective outcomes |
Unclear risk |
This study did not address objective outcomes. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
"Data from two participants were excluded from analyses because experimental conditions had been contaminated. One participant assigned to the distraction group had an unusually long wait on the procedure table and requested music in addition to the distraction stimulus. One participant assigned to the control group was exposed to music when the surgeon requested that it be played while he was in the room" |
| Selective reporting (reporting bias) |
Unclear risk |
Unknown if selective outcome reporting. |
| Protection from contamination? |
Low risk |
Two participants were excluded due to "contamination" |
