PregnancyNCT01012466
The Physical Effects of Pain Catastrophizing in Labor
An observational study of Pregnancy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether labor self-efficacy (as determined by scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jun 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Nulliparous women attending the prenatal clinic at Oregon Health \& Science University
Who may be able to join
- At least 20 weeks of pregnancy
- Nulliparous
- Singleton pregnancy
- Low risk pregnancy
Who cannot join
- 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
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- High risk pregnancies
- Severe mental illness that impairs cognition or function
- Suicidal ideation
- Women who do not speak English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: The Physical Effects of Pain Catastrophizing on Normal Labor
The purpose of this study is to determine whether labor self-efficacy (as determined by scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. 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.
Read the 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.
- Conditions
- Pregnancy
- Keywords
- pregnancy, birth, labor, labor pain, catastrophizing
- Medical subject headings
- Labor Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between pain catastrophizing and abnormal labor (deviation of progress in labor from norms)
Measured: Immediate postpartum
Secondary outcomes (2)
Relationship between pain catastrophizing and reported pain in labor
Measured: 1 day postpartum and 4-8 weeks postpartum
Relationship between pain catastrophizing and satisfaction with birth experience and care
Measured: 1 day postpartum and 4-8 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Darnall, PhD, Oregon Health and Science University
- Investigators
- Beth Darnall, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012466
- Sponsor's protocol ID
- 5203
- Other IDs
- 5K12HD04348807
- Status last verified
- Jul 2019
- First submitted
- 12 Nov 2009
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Physical Effects of Pain Catastrophizing on Normal Labor
- ClinicalTrials.gov ID
- NCT01012466
- Acronym / sponsor ID
- 5203
- Conditions
- Pregnancy
- Keywords
- pregnancy, birth, labor, labor pain, catastrophizing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether labor self-efficacy (as determined by scores for the Lederman PSEQ II (self-efficacy scores) impacts the second stage 2 length (nromal vs. prolonged) as determined by quartile ranges for our sample. 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Nulliparous women attending the prenatal clinic at Oregon Health \& Science University
Key inclusion criteria (4 listed)
- At least 20 weeks of pregnancy
- Nulliparous
- Singleton pregnancy
- Low risk pregnancy
Key exclusion criteria (10 listed)
- 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
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
Relationship between pain catastrophizing and abnormal labor (deviation of progress in labor from norms)
Time frame: Immediate postpartum
2 secondary outcomes
Relationship between pain catastrophizing and reported pain in labor
Time frame: 1 day postpartum and 4-8 weeks postpartum
Relationship between pain catastrophizing and satisfaction with birth experience and care
Time frame: 1 day postpartum and 4-8 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
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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.
Beth Darnall, PhD principal investigator
Oregon Health and Science University
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 Pregnancy, run by Oregon Health and Science University 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 4 inclusion and 10 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 29 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relationship between pain catastrophizing and abnormal labor (deviation of progress in labor from norms) (time frame: Immediate postpartum). 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 29 Jul 2019.