A neurofeedback-based intervention to reduce post-operative pain in lung cancer patients: study protocol for a randomized controlled trial.
BACKGROUND
Thoracic surgery appears to be the treatment of choice for many lung cancers. Nevertheless, depending on the type of surgery, the chest area may be painful for several weeks to months after surgery. This painful state has multiple physical and psychological implications, including respiratory failure, inability to clear secretions by coughing, and even anxiety and depression that have negative effects on recovery.


OBJECTIVE
The aim of this study is to evaluate the effect of a neurofeedback-based intervention on controlling acute post-surgery pain and improving long-term recovery in patients who undergo thoracotomy for lung resection for non-small cell lung cancer (NSCLC) at an academic oncologic hospital.


METHODS
This study will be based on a 2-parallel group randomized controlled trial design, intervention versus usual care, with multiple in-hospital assessments and 2 clinical, radiological, and quality of life follow-ups. Participants will be randomized to either the intervention group receiving a neurofeedback-based relaxation training and usual care, or to a control group receiving only usual care. Pain intensity is the primary outcome and will be assessed using the Numeric Pain Rating Scale (NRS) in the days following the operation. Secondary outcomes will include the effect of the intervention on hospital utilization for pain crisis, daily opioid consumption, anxiety, patient engagement, blood test and chest x-ray results, and long-term clinical, radiological, and quality of life evaluations. Outcome measures will be repeatedly taken during hospitalization, while follow-up assessments will coincide with the follow-up visits. Pain intensity will be assessed by mixed model repeated analysis. Effect sizes will be calculated as mean group differences with standard deviations.


RESULTS
We expect to have results for this study before the end of 2016.


CONCLUSIONS
The proposed innovative, neurofeedback- and relaxation-based approach to support post-surgery pain management could lead to significant improvements in patient short and long-term outcomes.
University of Milan, Department of Health Science, Milan, Italy. alessandra.gorini@unimi.it.
Alessandra
http://orcid.org/0000-0003-3216-1784
A
Gorini
Chiara
http://orcid.org/0000-0001-7761-2804
C
Marzorati
Monica
http://orcid.org/0000-0001-5986-7811
M
Casiraghi
Lorenzo
http://orcid.org/0000-0002-1068-3541
L
Spaggiari
Gabriella
http://orcid.org/0000-0002-9135-2938
G
Pravettoni
acute post-surgical pain; lung cancer; neurofeedback; relaxation; video games; virtual environments