The Physical Effects of Pain Catastrophizing in Labor

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Oregon Health and Science University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01012466
First received: November 12, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

The purpose of this study is to find out if negative thoughts have an effect on pain experienced during labor and how labor progresses. Other studies have shown that women who experience intense pain in the earliest stages of labor have a higher risk of complications. The investigators want to know if negative thoughts can predict this outcome.


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Physical Effects of Pain Catastrophizing on Normal Labor

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Relationship between pain catastrophizing and abnormal labor (deviation of progress in labor from norms) [ Time Frame: Immediate postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship between pain catastrophizing and reported pain in labor [ Time Frame: 1 day postpartum and 4-8 weeks postpartum ] [ Designated as safety issue: No ]
  • Relationship between pain catastrophizing and satisfaction with birth experience and care [ Time Frame: 1 day postpartum and 4-8 weeks postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: June 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Subjects will complete questionnaires at three timepoints: during the prenatal period, within 24-48 hours of giving birth, and 4-8 weeks postpartum. The questionnaires will measure pain catastrophizing, depression, maternal support, support and control in birth, and childbirth satisfaction. Chart review following delivery will record data such as length of labor, medication used, need for augmentation or surgical delivery, complications.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Nulliparous women attending the prenatal clinic at Oregon Health & Science University

Criteria

Inclusion Criteria:

  • At least 20 weeks of pregnancy
  • Nulliparous
  • Singleton pregnancy
  • Low risk pregnancy

Exclusion Criteria:

  • Primiparous and multiparous women
  • Women who request cesarean delivery
  • Women who are pregnant with twins
  • Women who plan induction
  • Women who deliver before 37 weeks
  • Women enrolled in the "Centering Pregnancy" program at the Family Birth Center
  • High risk pregnancies
  • Severe mental illness that impairs cognition or function
  • Suicidal ideation
  • Women who do not speak English or Spanish
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012466

Contacts
Contact: Katherine Volpe 530-519-3891 volpek@ohsu.edu
Contact: Katherine Parker, MSN 503-494-5224 parkerk@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Katherine Volpe    530-519-3891    volpek@ohsu.edu   
Principal Investigator: Beth Darnall, PhD         
Sub-Investigator: Jeanne-Marie Guise, MD, MPH         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Beth Darnall, PhD Oregon Health and Science University
  More Information

Additional Information:
No publications provided

Responsible Party: Beth Darnall, PhD, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT01012466     History of Changes
Other Study ID Numbers: 5203, 5K12HD04348807
Study First Received: November 12, 2009
Last Updated: November 12, 2009
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Oregon Health and Science University:
pregnancy
birth
labor
labor pain
catastrophizing

ClinicalTrials.gov processed this record on October 02, 2014