Trial Outcomes & Findings for Preventing Persistent Post-Surgical Pain and Dysfunction (NCT NCT03965897)
NCT ID: NCT03965897
Last Updated: 2026-05-06
Results Overview
Pain will be measured using the Brief Pain Inventory (BPI) Scale: 0-10, with higher scores meaning worse pain
COMPLETED
NA
402 participants
6 weeks postop, 3 months postop and 6 months postop
2026-05-06
Participant Flow
Unit of analysis: Workshops
Participant milestones
| Measure |
Attention Control (AC)
All participants were scheduled to attend one workshop. The workshop was held prior to surgery. On the day of each workshop, each workshop was randomized to be either Attention Control (AC) or Acceptance and Commitment Therapy (ACT). Everyone who attended that workshop was assigned to that treatment condition. The primary purpose of the AC workshop was to provide attention and education to participants. Topics of discussion included: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies were taught and a progressive muscle relaxation exercise was performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
All participants were scheduled to attend one workshop. This workshop was held prior to surgery. On the day of each workshop, each workshop was randomized to be either Attention Control (AC) or Acceptance and Commitment Therapy (ACT). Everyone who attended that group was assigned to that treatment condition. The ACT workshop included: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop also included information on pain and pain control post-total knee arthroplasty (TKA).
|
|---|---|---|
|
Workshop Attendance - Randomization
STARTED
|
193 33
|
209 33
|
|
Workshop Attendance - Randomization
COMPLETED
|
193 33
|
209 33
|
|
Workshop Attendance - Randomization
NOT COMPLETED
|
0 0
|
0 0
|
|
1 Week Post Surgery Assessment
STARTED
|
193 33
|
209 33
|
|
1 Week Post Surgery Assessment
COMPLETED
|
160 31
|
169 32
|
|
1 Week Post Surgery Assessment
NOT COMPLETED
|
33 2
|
40 1
|
|
6 Weeks Post Surgery Assessment
STARTED
|
160 31
|
169 32
|
|
6 Weeks Post Surgery Assessment
COMPLETED
|
157 31
|
166 32
|
|
6 Weeks Post Surgery Assessment
NOT COMPLETED
|
3 0
|
3 0
|
|
3 Months Post Surgery Assessment
STARTED
|
157 31
|
166 32
|
|
3 Months Post Surgery Assessment
COMPLETED
|
156 31
|
166 32
|
|
3 Months Post Surgery Assessment
NOT COMPLETED
|
1 0
|
0 0
|
|
6 Months Post Surgery Assessment
STARTED
|
156 31
|
166 32
|
|
6 Months Post Surgery Assessment
COMPLETED
|
154 31
|
166 32
|
|
6 Months Post Surgery Assessment
NOT COMPLETED
|
2 0
|
0 0
|
Reasons for withdrawal
| Measure |
Attention Control (AC)
All participants were scheduled to attend one workshop. The workshop was held prior to surgery. On the day of each workshop, each workshop was randomized to be either Attention Control (AC) or Acceptance and Commitment Therapy (ACT). Everyone who attended that workshop was assigned to that treatment condition. The primary purpose of the AC workshop was to provide attention and education to participants. Topics of discussion included: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies were taught and a progressive muscle relaxation exercise was performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
All participants were scheduled to attend one workshop. This workshop was held prior to surgery. On the day of each workshop, each workshop was randomized to be either Attention Control (AC) or Acceptance and Commitment Therapy (ACT). Everyone who attended that group was assigned to that treatment condition. The ACT workshop included: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop also included information on pain and pain control post-total knee arthroplasty (TKA).
|
|---|---|---|
|
1 Week Post Surgery Assessment
Did not have surgery
|
30
|
36
|
|
1 Week Post Surgery Assessment
Withdrawal by Subject
|
2
|
3
|
|
1 Week Post Surgery Assessment
Adverse Event
|
1
|
0
|
|
1 Week Post Surgery Assessment
Lost to Follow-up
|
0
|
1
|
|
6 Weeks Post Surgery Assessment
Withdrawal by Subject
|
3
|
3
|
|
3 Months Post Surgery Assessment
Study ended before participant reached 3 months post surgery
|
1
|
0
|
|
6 Months Post Surgery Assessment
Lost to Follow-up
|
1
|
0
|
|
6 Months Post Surgery Assessment
Study ended before participant reached 6 months post surgery
|
1
|
0
|
Baseline Characteristics
Preventing Persistent Post-Surgical Pain and Dysfunction
Baseline characteristics by cohort
| Measure |
Attention Control (AC)
n=163 Participants
The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
n=173 Participants
The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.
|
Total
n=336 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 8.4 • n=54 Participants
|
66.2 years
STANDARD_DEVIATION 9.4 • n=60 Participants
|
66.4 years
STANDARD_DEVIATION 8.9 • n=114 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=54 Participants
|
26 Participants
n=60 Participants
|
47 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=54 Participants
|
147 Participants
n=60 Participants
|
289 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=54 Participants
|
16 Participants
n=60 Participants
|
27 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
141 Participants
n=54 Participants
|
139 Participants
n=60 Participants
|
280 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=54 Participants
|
18 Participants
n=60 Participants
|
29 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=54 Participants
|
5 Participants
n=60 Participants
|
7 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=54 Participants
|
31 Participants
n=60 Participants
|
74 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
104 Participants
n=54 Participants
|
126 Participants
n=60 Participants
|
230 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
3 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=54 Participants
|
10 Participants
n=60 Participants
|
20 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
163 Participants
n=54 Participants
|
173 Participants
n=60 Participants
|
336 Participants
n=114 Participants
|
|
BPI Pain Severity Subscale
|
6.4 units on a scale
STANDARD_DEVIATION 1.7 • n=54 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 1.8 • n=60 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 1.8 • n=114 Participants
|
|
KOOS ADL
|
38.5 units on a scale
STANDARD_DEVIATION 15.32 • n=54 Participants
|
39.1 units on a scale
STANDARD_DEVIATION 15.56 • n=60 Participants
|
38.8 units on a scale
STANDARD_DEVIATION 15.42 • n=114 Participants
|
|
DASS-21 Anxiety
|
3.7 units on a scale
STANDARD_DEVIATION 3.24 • n=54 Participants
|
3.5 units on a scale
STANDARD_DEVIATION 2.94 • n=60 Participants
|
3.6 units on a scale
STANDARD_DEVIATION 3.08 • n=114 Participants
|
|
DASS-21 Depression
|
4.9 units on a scale
STANDARD_DEVIATION 4.44 • n=54 Participants
|
4.3 units on a scale
STANDARD_DEVIATION 3.99 • n=60 Participants
|
4.6 units on a scale
STANDARD_DEVIATION 4.22 • n=114 Participants
|
|
CPAQ
|
55.9 units on a scale
STANDARD_DEVIATION 19.61 • n=54 Participants
|
58.4 units on a scale
STANDARD_DEVIATION 10.08 • n=60 Participants
|
57.2 units on a scale
STANDARD_DEVIATION 18.71 • n=114 Participants
|
|
CPVI Success
|
2.9 units on a scale
STANDARD_DEVIATION 1.16 • n=54 Participants
|
2.8 units on a scale
STANDARD_DEVIATION 1.14 • n=60 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 1.15 • n=114 Participants
|
|
Pain Management Strategies Survey (PMSS)
Pharmacological
|
163 Participants
n=54 Participants
|
173 Participants
n=60 Participants
|
336 Participants
n=114 Participants
|
|
Pain Management Strategies Survey (PMSS)
Non-Pharmacological
|
163 Participants
n=54 Participants
|
173 Participants
n=60 Participants
|
336 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postop, 3 months postop and 6 months postopPopulation: Participants followed to 6 months postoperatively
Pain will be measured using the Brief Pain Inventory (BPI) Scale: 0-10, with higher scores meaning worse pain
Outcome measures
| Measure |
Attention Control (AC)
n=154 Participants
The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
n=166 Participants
The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.
|
|---|---|---|
|
Pain Intensity
6 Weeks Postop
|
4.1 units on a scale
Standard Deviation 1.95
|
3.9 units on a scale
Standard Deviation 2.02
|
|
Pain Intensity
3 Months Postop
|
3.9 units on a scale
Standard Deviation 1.94
|
3.4 units on a scale
Standard Deviation 2.11
|
|
Pain Intensity
6 Months Postop
|
3.9 units on a scale
Standard Deviation 2.06
|
3.9 units on a scale
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: 6 weeks postop, 3 months postop, and 6 months postopPopulation: Up to 6 months postoperatively
Knee Injury and Osteoarthritis Outcome Score (KOOS), Activities of Daily Living (ADL) subscore. Scale: 0-100, with lower scores indicating poorer function.
Outcome measures
| Measure |
Attention Control (AC)
n=154 Participants
The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
n=166 Participants
The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.
|
|---|---|---|
|
Function
6 Weeks Postop
|
59.3 units on a scale
Standard Deviation 20.29
|
63.4 units on a scale
Standard Deviation 16.56
|
|
Function
3 Months Postop
|
65.8 units on a scale
Standard Deviation 18.81
|
69.9 units on a scale
Standard Deviation 17.68
|
|
Function
6 Months Postop
|
68.9 units on a scale
Standard Deviation 19.92
|
70.5 units on a scale
Standard Deviation 19.67
|
SECONDARY outcome
Timeframe: 6 weeks postop, 3 months postop, and 6 months postopPopulation: Up to 6 Months Postoperatively
Depression, Anxiety and Stress Scale (DASS-21), Anxiety subscale. Range: 0-21 Lower scores indicate less severe anxiety
Outcome measures
| Measure |
Attention Control (AC)
n=154 Participants
The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
n=166 Participants
The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.
|
|---|---|---|
|
Anxiety
6 Weeks Postop
|
3.2 units on a scale
Standard Deviation 2.96
|
2.9 units on a scale
Standard Deviation 2.44
|
|
Anxiety
3 Months Postop
|
3.2 units on a scale
Standard Deviation 3.10
|
2.9 units on a scale
Standard Deviation 2.84
|
|
Anxiety
6 Months Postop
|
3.4 units on a scale
Standard Deviation 3.26
|
2.9 units on a scale
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: 6 weeks postop, 3 months postop, and 6 months postopPopulation: Up to 6 Months Postoperatively
Depression, Anxiety and Stress Scale (DASS-21), Depression subscale Scale: 0-21 Lower scores indicate less severe depression
Outcome measures
| Measure |
Attention Control (AC)
n=154 Participants
The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
n=166 Participants
The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.
|
|---|---|---|
|
Depressive Symptoms
6 Weeks Postop
|
4.0 units on a scale
Standard Deviation 4.08
|
3.7 units on a scale
Standard Deviation 3.38
|
|
Depressive Symptoms
3 Month Postop
|
4.2 units on a scale
Standard Deviation 4.35
|
3.5 units on a scale
Standard Deviation 3.54
|
|
Depressive Symptoms
6 Months Postop
|
4.5 units on a scale
Standard Deviation 4.89
|
3.6 units on a scale
Standard Deviation 3.60
|
SECONDARY outcome
Timeframe: 6 weeks postop, 3 months postop, and 6 months postopPopulation: Up to 6 months postoperatively
Chronic Pain Acceptance Questionnaire (CPAQ) Scale: 0-120 Higher score indicates higher level of pain acceptance
Outcome measures
| Measure |
Attention Control (AC)
n=154 Participants
The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
n=166 Participants
The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.
|
|---|---|---|
|
Level of Pain Acceptance
6 Weeks Postop
|
65.0 units on a scale
Standard Deviation 22.05
|
67.3 units on a scale
Standard Deviation 19.35
|
|
Level of Pain Acceptance
3 Months Postop
|
68.7 units on a scale
Standard Deviation 20.40
|
73.2 units on a scale
Standard Deviation 20.59
|
|
Level of Pain Acceptance
6 Months Postop
|
70.2 units on a scale
Standard Deviation 20.95
|
73.2 units on a scale
Standard Deviation 21.02
|
SECONDARY outcome
Timeframe: 6 weeks postop, 3 months postop, and 6 months postopPopulation: Up to 6 Months Postoperatively
Chronic Pain Values Inventory Scale: 0-5 Lower score indicates suffering while higher score is associated with better concurrent and future functioning.
Outcome measures
| Measure |
Attention Control (AC)
n=154 Participants
The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
n=166 Participants
The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.
|
|---|---|---|
|
Level of Success in Engagement in Values-Based Behavior
6 Weeks Postop
|
2.9 units on a scale
Standard Deviation 1.18
|
3.1 units on a scale
Standard Deviation 1.09
|
|
Level of Success in Engagement in Values-Based Behavior
3 Months Postop
|
3.1 units on a scale
Standard Deviation 1.2
|
3.2 units on a scale
Standard Deviation 1.09
|
|
Level of Success in Engagement in Values-Based Behavior
6 Months Postop
|
3.1 units on a scale
Standard Deviation 1.12
|
3.3 units on a scale
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: 3 months postop and 6 months postopPopulation: Up to 6 months postoperatively
Pain Management Strategies Survey Survey of use of pharm and non-pharm pain relief strategies. No score. We are reporting on the number of participants who completed the survey.
Outcome measures
| Measure |
Attention Control (AC)
n=154 Participants
The primary purpose of this workshop is to provide attention and education to participants. Topics of discussion will include: a) the pathophysiology of postoperative pain and how it differs from preoperative pain, b) the role of contextual factors (e.g., depressive or anxiety symptoms, expectation) on the experience of pain, d) the role of inflammation in pain and healing, e) types of pain medications and other pain relief strategies provided following surgery, and f) goals of pain medications. Additionally, deep (diaphragmatic) breathing strategies will be taught and a progressive muscle relaxation exercise will be performed in the workshop at strategic times to maintain Veteran engagement.
|
Acceptance and Commitment Therapy (ACT)
n=166 Participants
The ACT intervention will include: 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts such as "I can't take this pain anymore" or "This is unfair") and learning how to willingly face experiences that cannot be changed; and 2) Behavioral Change Training involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise. The workshop will also include information on pain and pain control post-TKA.
|
|---|---|---|
|
Number of Participants Using Pain Management Strategies
Pharmacologic 3 Months Postop
|
154 Participants
|
166 Participants
|
|
Number of Participants Using Pain Management Strategies
Pharmacologic 6 Months Postop
|
154 Participants
|
166 Participants
|
|
Number of Participants Using Pain Management Strategies
Non-Pharmacologic 3 Months Postop
|
154 Participants
|
166 Participants
|
|
Number of Participants Using Pain Management Strategies
Non-Pharmacologic 6 Months Postop
|
154 Participants
|
166 Participants
|
Adverse Events
Attention Control (AC)
Acceptance and Commitment Therapy (ACT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place