Persistent Post-surgical Pain, Veterans
Conditions
Brief summary
The study team propose to investigate the feasibility and pilot a Telephone Cognitive Behavioral Therapy intervention for those identified to be at risk for chronic pain following surgery.
Interventions
BEHAVIORALTelephone-based Cognitive Behavioral Therapy (CBT)
Four session telephone CBT protocol.
Sponsors
Iowa City Veterans Affairs Medical Center
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1\) \>18 years of age, 2) scheduled for hernia repair, breast surgery, amputation, thoracotomy, cholecystectomy, cardiac surgery, splenectomy, orthopedic, urological or vascular surgery, 3) Rural dwelling
Exclusion criteria
1\) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity | 3 months post-surgery | Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity - continuous | 3 months post-surgery | Brief Pain Inventory |
| Pain-related functioning | 3 months post-surgery | Pain Disability Index |
| Opioid and other analgesic use | 3 months post-surgery | Self-report medication use |
| Qualitative analysis of feasibility data | Between 1-2 weeks post-TCBT | Qualitative interviews with a subset of TCBT participants, until data saturation is reached. |
| Anxiety | 3 months post-surgery | Generalized Anxiety Disorder Scale * Generalized Anxiety Disorder 7-item (GAD-7) scale measures endorsement/symptoms of generalized anxiety. * The scores for each individual question range from 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). A total score can range from 0-21. * A score of 5 is a cut-off for mild anxiety, 10 is a cut-off for moderate anxiety, and 15 is a cut-off for severe anxiety. Higher values represent worse outcomes. * To compute a total score, all items with endorsements of 1 or greater are added together for a composite score of 0-21. |
| Health-related quality of life: SF-36 | 3 months post-surgery | SF-36 * 36-Item Short Form Survey Instrument (SF-36) measures eight constructs related to quality of life: * Physical functioning * Role limitations due to physical health * Role limitations due to emotional problems * Energy/fatigue * Emotional well-being * Social functioning * Pain * General health * Each item is recoded to reflect score ranges from 0 to 100 where 0 is the least favorable and 100 is the most favorable. Each item corresponds to a specific construct. Items associated with each construct are averaged to retrieve a construct score. Scores are then converted into z-scores. * Higher z-scores reflect a more favorable health status. |
| Patient satisfaction with outcomes | 3 months post-surgery | Brief satisfaction items regarding TCBT intervention (Only for participants assigned to receive TCBT) 1. Overall, how satisfied are you with the TCBT? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) 2. How satisfied are you with the TCBT for reducing your pain or helping you cope with your pain? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied) 3. How satisfied are you with the TCBT for improving your functioning? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied). |
| Depression | 3 months post-surgery | Patient Health Questionnaire |
Countries
United States
Outcome results
None listed