We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Association Between Pain Catastrophizing Scale Score and Postspinal Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02727244
Recruitment Status : Not yet recruiting
First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia.

Condition or disease Intervention/treatment
Pain Headache Procedure: urgent or elective cesarean section

Detailed Description:
This study is aimed to elucidate the association between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia. Patients were asked to fill the questionnaire booklet including Pain Catastrophizing Scale, Beck Depression Inventory and Beck Anxiety Inventory before elective cesarean section in preoperative room in operating theater. In postoperative second and fourth day, patients will call by phone and be asked to have headache or any complaints. The intensity of headache will evaluate by using visual analog scale. Age, gender, and visual analog scale scores will be recorded.

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Is There an Association Between Pain Catastrophizing Scale Score and Postspinal Headache in Patients Underwent Cesarean Section With Spinal Anesthesia?
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: urgent or elective cesarean section
    a kind of surgical procedure to deliver a baby

Outcome Measures

Primary Outcome Measures :
  1. pain catastrophizing scale score [ Time Frame: one time in one year ]

Secondary Outcome Measures :
  1. Beck depression inventory [ Time Frame: one time in one year ]
  2. beck anxiety inventory [ Time Frame: one time in one year ]
  3. visual analog scale score [ Time Frame: one time in one year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
women with pregnancy whose planned to undergo urgent or elective cesarean section
Criteria

Inclusion Criteria:

  • American Society of Anesthesiologists score of I, II, III
  • without a history of cerebrovascular diseases
  • without any presence of psychiatric diseases

Exclusion Criteria:

  • severe liver, kidney and cardiovascular diseases
  • peripheral arterial diseases
  • a history of allergy to local anesthetics
  • patients without cooperation
  • not to participate in the study
  • presence of neurologic or neuromuscular diseases
More Information

Responsible Party: Mustafa Suren, Associate Professor, Tokat Gaziosmanpasa University
ClinicalTrials.gov Identifier: NCT02727244     History of Changes
Other Study ID Numbers: 16-KAEK-071
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: April 4, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mustafa Suren, Tokat Gaziosmanpasa University:
Pain Catastrophizing Scale

Additional relevant MeSH terms:
Headache
Post-Dural Puncture Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases