Persistent Pain After CS Delivery

Completed

• Conditions: Persistent Pain After Delivery

• Registration Number: NCT01996592
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-11-21
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2017-06-15
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-10
• Last Update Submitted: 2018-08-10
• Results First Posted: 2018-08-13
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 575

Inclusion Criteria

• >/= 18 years of age English speaking

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Exclusion Criteria

non-English speaking

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States