Persistent Pain After DeliveryNCT01996592
Persistent Pain After CS Delivery
An observational study of Persistent Pain After Delivery, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Persistent Pain After Delivery
- How many people
- 575 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jan 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: 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
Who may be able to join
- >/= 18 years of age English speaking
Who cannot join
- non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
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..
Read the 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.
- Conditions
- Persistent Pain After Delivery
- Keywords
- chronic pain, cesarean section pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startMay 2013
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Persistent Pain After DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Booth, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996592
- Sponsor's protocol ID
- IRB00022468
- Status last verified
- Aug 2018
- First submitted
- 21 Nov 2013
- Last updated
- 13 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01996592
- Acronym / sponsor ID
- IRB00022468
- Conditions
- Persistent Pain After Delivery
- Keywords
- chronic pain, cesarean section pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 13 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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
Key inclusion criteria (1 listed)
- >/= 18 years of age English speaking
Key exclusion criteria (1 listed)
- non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Persistent Pain After Delivery
Not yet recruiting
CODEPAD-III (Collaborative Outcomes of DEpression and Pain Associated With Delivery-III)
Depression, Postpartum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Booth, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Pain After Delivery, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Pain-PERCEIVED STRESS Scores Stratified by the Rate of Recovery (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.