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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..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 60 days |
| 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 | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
non-English speaking
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those subjects who are scheduled to have an elective cesarean section (CS) and able to complete a preoperative psychosocial/depressive questionnaire and who agree to be contacted on a daily basis for 60 days postoperatively
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| Name | Affiliation | Role |
|---|---|---|
| Jessica Booth, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
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Elective cesarean section patients >/= 18 years of age who agree to be contacted for 8 weeks after delivery to obtain pain scores
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 60 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica L. Booth, MD | Wake Forest School of Medicine | 336-718-8278 | jbooth@wakehealth.edu |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| change in mode of delivery |
|
| Participants |
|
| Sex: Female, Male | 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4 | Count of Participants | Participants |
|
| Race (NIH/OMB) | 575 enrolled; 530 analyzed. 45 subjects were excluded for the following reasons: no response to text/no diary entry: 32 change in surgical date: 4 withdrew consent prior to study initiation: 5 change in mode of delivery: 4 | Count of Participants | Participants | No |
|
| Group 2 Perceived Stress Scale |
Subjects who experienced average recovery |
| OG002 | Group 3 Perceived Stress Scale | Subjects who experienced the slowest recovery from surgery |
|
|
|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 60 days |
|
|
|
|
| 0 |
| 530 |
| 0 |
| 530 |
| 0 |
| 530 |
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