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FeelGood: Increasing perioperative positive emotions by Cognitive Bias Modification

FeelGood: Increasing perioperative positive emotions by Cognitive Bias Modification - FeelGood

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56930
Enrollment
40
Registered
2023-08-31
Start date
2025-01-10
Completion date
Unknown
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anxiety for operation pain after operation

Interventions

In the active CBM condition, patients receive treatment as usual (TAU) and&nbsp
perform 2 weekly sessions of the active CBM training for 4 weeks. In the&nbsp
control CBM training patients will receive sham training concurrent to TAU. The&nbsp
brief (app. 20 minute) CBM sessions of cognitive training will be done on a&nbsp
computer. The sessions are planned so that they do not interfere with medical&nbsp
treatment patients might receive.&nbsp

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Trial: Difference in Anxiety and depression (HADS) between baseline and post-training/preoperative.

Secondary

MeasureTime frame
Bias change as measured at the start of the first and end of the last CBM session * 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 pain and impact on functioning (BPI) 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.

Countries

Netherlands

Contacts

Public ContactJ Vrijssen

Radboud Universitair Medisch Centrum

janna.vrijsen@radboudumc.nl(024-36)10685

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)