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Clinical Trials/NCT01996592
NCT01996592
Completed
Not Applicable

Novel Approach Using Pre-surgery Psychosocial State and Pain Trajectory Methods to Identify Patient Characteristics and Predict Patients at Risk for Persistent Pain After Cesarean Delivery

Wake Forest University Health Sciences1 site in 1 country575 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Persistent Pain After Delivery
Sponsor
Wake Forest University Health Sciences
Enrollment
575
Locations
1
Primary Endpoint
Persistent Pain-EMOTIONAL DISTRESS
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
January 2016
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • \>/= 18 years of age English speaking

Exclusion Criteria

  • non-English speaking

Outcomes

Primary Outcomes

Persistent Pain-EMOTIONAL DISTRESS

Time Frame: 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

Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery

Time Frame: 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.

Study Sites (1)

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