| |
Study period
|
---|
|
Enrolment
|
Allocation
|
Post-allocation
|
Primary and secondary outcomes
|
---|
Time point
|
-t1
|
0
|
14 days pre-op
|
7 days pre- op
|
Intra-operative
|
24-48 h post-op
|
7 days post- op
|
14 days post- op
|
30 days
|
90 days
|
---|
Enrolment:
|
Eligibility screen (inclusion and exclusion criteria)
|
X
| | | | | | | | | |
Informed consent
|
X
| | | | | | | | | |
Baseline PCS (> 24: eligible to enrol)
|
X
| | | | | | | | | |
Randomisation
| |
X
| | | | | | | | |
Interventions:
|
CBT session group
| | |
X
|
X
| | |
X
|
X
| | |
PEM session group
| | |
X
|
X
| | |
X
|
X
| | |
Assessments:
|
Patient demographics and characteristics
|
X
| | | | | | | | | |
Intraoperative data
| | | | |
X
| | | | | |
BPI
| |
X
| | | | | | |
X
|
X
|
QoR-15
| | | | | |
X
| | | | |
PCS
|
x
| | | | | | | |
X
|
X
|
HADS
| | | | | | | | |
X
|
X
|
- PCS Pain Catastrophising Scale, CBT cognitive behavioural therapy, PEM pain education and mindfulness, BPI Brief Pain Inventory score, QoR-15 Quality of Recovery-15 score, HADS Hospital Anxiety and Depression Scale