To study the efficacy of preoperative CBM in patients with increased anxiety levels undergoing knee- or spine surgery with expected postoperative moderate to severe pain.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Trial: Difference in Anxiety and depression (HADS) between baseline and
post-training/preoperative.
Secondary outcome
Bias change as measured at the start of the first and end of the last CBM
session (this is not measured in the no-intervention condition) *
Surgery related anxiety (APAIS) between baseline and post-training/preoperative
Change in Anxiety and depression (HADS) between baseline and POD 7, 28 and
month 3
Difference in PAIN OUT-patient outcome on POD 1
Change in neuropathic pain symptoms (DN2) between baseline and POD 7, 28 and
month 3
Change in pain and impact on functioning (BPI) between baseline and POD 7, 28
and month 3
Change in catastrophizing (PCS) between baseline and POD 7, 28 and month 3
Use of opioids (Oral Morphine Equivalent) at baseline, preoperative, POD 1, 7,
28 and month 3.
Background summary
A large group of patients experiences moderate to severe pain after surgery
impacting recovery and quality of life, despite optimizing (intrahospital)
perioperative pain management. Female gender, preoperative pain, opioid use,
emotional distress and type of surgery are known risk factors for developing
pain after surgery. There is growing interest in improving pain management by
implementing interventions in patients at risk during the entire perioperative
period. Cognitive bias modification (CBM) is a promising fast acting
non-intrusive computerized cognitive intervention aiming at enhancing a healthy
positive information processing style, which could play a role in reducing
preoperative emotional symptoms and thereby reducing postoperative pain.
Study objective
To study the efficacy of preoperative CBM in patients with increased anxiety
levels undergoing knee- or spine surgery with expected postoperative moderate
to severe pain.
Study design
The study will be a prospective single centre randomized controlled trial.
Patients will be randomized to receive preoperatively a CBM intervention (group
I), a sham intervention (group II) or no intervention (group III) and will be
followed till 3 months after surgery.
Intervention
In the active CBM condition, patients receive treatment as usual (TAU) and
perform 2 weekly sessions of the active CBM training for 4 weeks. In the
control CBM training patients will receive sham training concurrent to TAU. The
brief (app. 20 minute) CBM sessions of cognitive training will be done on a
computer. The sessions are planned so that they do not interfere with medical
treatment patients might receive. The non-intervention group will receive no
CBM training but changes in distress and other outcomes will be assessed to
document natural changes.
Study burden and risks
Patients will receive a 4-week training before surgery and will be followed
until 3 months after surgery. At 6 moments during this period, it will be asked
to fill in questionnaires, which we will try to confine with regular follow up.
In addition to normal care, time investment for patients in the (CBM or sham)
intervention group will be 4.5 hours and 1.5 hours in the no intervention
group.
We expect no additional risk for patients in the CBM or sham intervention
group.
Renier Postlaan 10
Nijmegen 6525GC
NL
Renier Postlaan 10
Nijmegen 6525GC
NL
Listed location countries
Age
Inclusion criteria
Receiving knee- or spine surgery with expected postoperative moderate to severe
pain, scheduled >= 4 weeks after TPS.
>=11 on the APAIS
Signed informed consent form
>=18 years
Exclusion criteria
Impossibility to obtain a valid informed consent
Insufficient comprehension of the Dutch language
Acuteness of symptoms (somatic or psychiatric) that prevent patient from
attentively doing the task 20 min per day
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | https://osf.io/8PQHJ |
| CCMO | NL85252.091.23 |