| Methods |
Design: three group parallel trial
Purpose: examine the effect of preoperative interview and placebo interview on postoperative pain and recovery |
| Participants |
Patients: women undergoing elective laparoscopy
Baseline comparability: yes (age) |
| Interventions |
Placebo: preparation interview with neutral questions about hospitalisation in general
Untreated: no preparation interview
Experimental: preparation interview presenting 'information in a reassuring /supportive way'
(Co‐intervention: analgesics on demand, type and dose NS, 7 from placebo and 9 from untreated group required pain medication) |
| Outcomes |
Pain (numerical/verbal rating scale)
Time to return to health and work |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/interview) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
High risk |
Either variance inequality (F‐test statistically significant) or skewness (1.64 standard deviations exceeds the mean) |
| Trial size > 49? |
High risk |
N = 38 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
