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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03351309
Other study ID # 201708823
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2017
Est. completion date August 1, 2021

Study information

Verified date August 2021
Source Iowa City Veterans Affairs Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date August 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Intervention

Behavioral:
Telephone-based Cognitive Behavioral Therapy (CBT)
Four session telephone CBT protocol.

Locations

Country Name City State
United States Iowa City VA Medical Center Iowa City Iowa

Sponsors (2)

Lead Sponsor Collaborator
Iowa City Veterans Affairs Medical Center US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Severity Numeric Rating Scale of surgical site pain: none-mild (0-3) compared to Moderate-severe (4+) 3 months post-surgery
Secondary Qualitative analysis of feasibility data Qualitative interviews with a subset of TCBT participants, until data saturation is reached. Between 1-2 weeks post-TCBT
Secondary Pain severity - continuous Brief Pain Inventory 3 months post-surgery
Secondary Pain-related functioning Pain Disability Index 3 months post-surgery
Secondary Opioid and other analgesic use Self-report medication use 3 months post-surgery
Secondary Depression Patient Health Questionnaire 3 months post-surgery
Secondary Anxiety 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.
3 months post-surgery
Secondary Health-related quality of life: SF-36 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.
3 months post-surgery
Secondary Patient satisfaction with outcomes Brief satisfaction items regarding TCBT intervention (Only for participants assigned to receive TCBT)
Overall, how satisfied are you with the TCBT? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied)
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)
How satisfied are you with the TCBT for improving your functioning? (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied).
3 months post-surgery
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