Persistent Pain After Delivery
Conditions
Keywords
chronic pain, cesarean section pain
Brief summary
Many factors influence the development of persistent pain after CS (chronic pain) as well as post-partum depression. We are attempting to use trajectory pain methods in an attempt to identify those at risk for the development of persistent pain post delivery using a daily method of contact for the determination of pain scores. Assessments are also done evaluating satisfaction of pain management and maternal/infant bonding opportunities. Physical activity is monitored by subject's wearing a Fitbit with correlation being done with pain scores obtained over 60 days postop with eligible subjects..
Detailed description
Subjects are contacted on a daily basis after having a cesarean delivery to determine current pain, current pain unpleasantness, worst pain, worst pain unpleasantness, average pain, and average pain unpleaseantness. Preoperatively subjects complete a psycho-social/depressive screening questionnaire. Pain treatments/satisfaction assessments are captured for the first 24 hours. Mother/baby outcomes are also captured. Physical activity and pain scores are also correlated with the subject's wearing of a Fitbit physical activity bracelet with eligible subjects for 60 days post-delivery.
Interventions
None listed
Sponsors
Wake Forest University Health Sciences
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* \>/= 18 years of age English speaking
Exclusion criteria
non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery | 60 days | By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the average recovery, and group 3 which is the group with the slowest recovery. |
| Persistent Pain-EMOTIONAL DISTRESS | 60 days | By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the average recovery, and group 3 which is the group with the slowest recovery. PROMIS Emotional Distress-Depression Short form utilized for this outcome. scoring for this ranges from 8-40, with the higher the score the worse the distress |
Countries
United States
Participant flow
Recruitment details
Elective cesarean section patients \>/= 18 years of age who agree to be contacted for 8 weeks after delivery to obtain pain scores
Participants by arm
| Arm | Count |
|---|---|
| Cesarean Section Deliveries those subjects having an elective cesarean section will complete an informed consent form, complete the preoperative questionnaire, and then be contacted for 60 days postoperatively | 530 |
| Total | 530 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | change in mode of delivery | 4 |
| Overall Study | change in surgical date | 4 |
| Overall Study | no response to text/no diary entry | 32 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Cesarean Section Deliveries |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 530 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 138 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 384 Participants |
| Sex: Female, Male Female | 530 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 530 |
| other Total, other adverse events | 0 / 530 |
| serious Total, serious adverse events | 0 / 530 |
Outcome results
Primary
Persistent Pain-EMOTIONAL DISTRESS
By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the average recovery, and group 3 which is the group with the slowest recovery. PROMIS Emotional Distress-Depression Short form utilized for this outcome. scoring for this ranges from 8-40, with the higher the score the worse the distress
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-perceived Stress Scores | Persistent Pain-EMOTIONAL DISTRESS | 10.7 units on a scale | Standard Deviation 3.8 |
| Group 2 Perceived Stress Scale | Persistent Pain-EMOTIONAL DISTRESS | 11.5 units on a scale | Standard Deviation 4.2 |
| Group 3 Perceived Stress Scale | Persistent Pain-EMOTIONAL DISTRESS | 12.8 units on a scale | Standard Deviation 4.5 |
p-value: <0.01ANOVA
Primary
Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery
By identifying preoperative risk factors for chronic pain and mapping out the trajectory of pain after cesarean delivery, we may be able to use novel pharmacologic or psychological interventions to alter postoperative pain trajectories. Two predominant risk factors have been determined thus far to put those at risk. They are emotional distress/depression and perceived stress. The 530 participants recovery pain scores were broken down into 3 subgroups--group 1 is those who had the fastest recovery, group 2 which is the average recovery, and group 3 which is the group with the slowest recovery.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1-perceived Stress Scores | Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery | 11.4 units on a scale | Standard Deviation 5.8 |
| Group 2 Perceived Stress Scale | Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery | 12.9 units on a scale | Standard Deviation 5.8 |
| Group 3 Perceived Stress Scale | Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery | 15.4 units on a scale | Standard Deviation 5.4 |
Comparison: PROMIS -perceived stress scale was utilized (a validated test). Scoring ranges from 0-40, with the following ranges indicative of low, moderate, or high perceived stress:~0-13=low stress 14-26=moderate stress 27-40=high perceived stressp-value: <0.01ANOVA