| Methods |
Design: three group parallel trial
Purpose: examine the effect of relaxation + guided imagery (and attention‐placebo) on physical and psychological aspects of rehabilitation following orthopedic surgery |
| Participants |
Patients: patients having had performed anterior cruciate ligament reconstruction
Baseline comparability: NS |
| Interventions |
Placebo: over a period of 6 months, 10 sessions of 30 to 40 minutes of encouragement, support and reminders to visualise a peaceful scene daily
Untreated: no sessions
Experimental: sessions of structured relaxation and guided imagery
(Co‐intervention: physical therapy) |
| Outcomes |
Pain (11 point scale, 0 to 10)
Re‐injury anxiety
Knee strength (ratio of injured knee to the uninjured knee) |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
'random block' |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/relaxation) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 20 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
