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The Chronic Pain Incidence After Elective and Urgent Cesarean Sections

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ClinicalTrials.gov Identifier: NCT02656264
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Hakan Tapar, Tokat Gaziosmanpasa University

Brief Summary:
The purpose of this study is to determine the effects of whether urgent or elective cesarean section on the occurrance of chronic pain.

Condition or disease
Chronic Pain

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Chronic Pain Incidence After Elective and Urgent Cesarean Sections
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. numeric rating scale [ Time Frame: One time when calling the patient, an avarage of three months ]

Secondary Outcome Measures :
  1. pain catastrophizing scale [ Time Frame: one time in operating theatre, an avarage of three months ]
  2. presence of chronic pain using numeric rating scale [ Time Frame: One time when calling the patient, an avarage of three months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Female
  • 18 - 45 years of age
  • underwent elective or urgent cesarean section
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656264


Locations
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Turkey
Gaziosmanpasa University
Tokat, Turkey, 60200
Sponsors and Collaborators
Tokat Gaziosmanpasa University
Investigators
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Principal Investigator: Hakan Tapar, Assist.Prof. Gaziosmanpasa University

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Responsible Party: Hakan Tapar, Assistant Professor, MD, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT02656264     History of Changes
Other Study ID Numbers: 15-KAEK-028
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms