- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02656264
The Chronic Pain Incidence After Elective and Urgent Cesarean Sections
October 19, 2017 updated by: Hakan Tapar, Tokat Gaziosmanpasa University
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain.
Study Overview
Status
Completed
Conditions
Detailed Description
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain.
Patients aged between 18 - 45 years whose underwent urgent or elective cesarean section will be invited to participate in the study.
Preoperatively in operating theatre, patients will be asked to complete the pain catastrophizing scale (PCS) questionnaire.
In postoperative 6 months after discharge, patients will be called by an investigator who is blind to the study to evaluate the presence of chronic pain.
Patients will be asked to grade the pain that they suffer using a numeric rating scale for the intensity of pain.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Tokat, Turkey, 60200
- Gaziosmanpasa University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
- Female
- 18 - 45 years of age
- underwent elective or urgent cesarean section
Description
Inclusion Criteria:
- Female
- 18 - 45 years of age
- underwent elective or urgent cesarean section
Exclusion Criteria:
- not willing to participate in the study
- can not reach by phone
- use of anti-psychotic or anti-depressant drugs
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
numeric rating scale
Time Frame: One time when calling the patient, an avarage of three months
|
One time when calling the patient, an avarage of three months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain catastrophizing scale
Time Frame: one time in operating theatre, an avarage of three months
|
one time in operating theatre, an avarage of three months
|
presence of chronic pain using numeric rating scale
Time Frame: One time when calling the patient, an avarage of three months
|
One time when calling the patient, an avarage of three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hakan Tapar, Assist.Prof., Gaziosmanpasa University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
May 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
December 24, 2015
First Submitted That Met QC Criteria
January 12, 2016
First Posted (Estimate)
January 14, 2016
Study Record Updates
Last Update Posted (Actual)
October 20, 2017
Last Update Submitted That Met QC Criteria
October 19, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-KAEK-028
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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