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The Effect of a Culturally Sensitive Educational Intervention on Acceptance of Neuraxial Anesthesia

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672397
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Brandon Togioka, Oregon Health and Science University

Brief Summary:

The purpose of this study is to see if an educational intervention provided to pregnant women in early labor has an effect on their decision to use epidural anesthesia for relief of labor pain. The study will also investigate differences between Hispanic and non-Hispanic white women in their attitudes and beliefs regarding epidurals in labor. Previous studies have shown that Hispanic women receive epidural anesthesia in labor much less frequently than their non-Hispanic white counterparts. The investigators hypothesize that the rate of epidural use will be higher in subjects who receive the educational intervention than in those who do not.

Women who have been admitted to the OHSU labor and delivery unit will be screened for study eligibility. In order to minimize the influence of socioeconomic factors, only women receiving Medicaid will be enrolled. Other inclusion criteria include age of at least 18 years, having a fetus of at least 24 weeks gestational age, and being categorized as American Society of Anesthesiologist category 1 to 3. Exclusion criteria include any condition that either excludes or mandates neuraxial anesthesia. Midwife patients are also excluded from this study. Those who meet study criteria will be approached by a member of the study team and informed consent will be obtained.

Subjects will be randomly assigned to receive an educational intervention about epidurals or no educational intervention. Hispanic and non-Hispanic subjects will be randomized separately, yielding four study groups (Hispanic - intervention; Hispanic - control; non-Hispanic - intervention, non-Hispanic - control). The investigators expect to enroll approximately 176 women, 44 in each group.

All subjects will complete a survey in early labor and again 1 to 2 days postpartum that asks about common beliefs and misconceptions regarding epidurals. Subjects in the intervention group will receive an educational pamphlet and watch a video in their native language (spanish or english) about epidurals, and have an opportunity to ask questions. Study staff will collect limited information about the subject's labor and delivery from the electronic medical record.


Condition or disease Intervention/treatment Phase
Labor Pain Behavioral: Additional Epidural Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Health Services Research
Official Title: The Effect of a Culturally Sensitive Educational Intervention on Acceptance of Neuraxial Anesthesia in Hispanic and Caucasian Parturients: A Randomized Controlled Trial
Actual Study Start Date : February 10, 2015
Actual Primary Completion Date : February 25, 2017
Actual Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: Hispanic Intervention
Hispanic subjects that receive additional epidural education [44 patients]
Behavioral: Additional Epidural Education
All women allocated to receive additional epidural educational will be given a language appropriate pamphlet and video on neuraxial anesthesia. The video and pamphlet will be in the subject's primary language. After the subject watches the educational video they will be given an opportunity to go through the pamphlet with the research assistant and ask any questions they may have. For Spanish-speaking subjects this will occur through a telephone interpreter. The obstetric anesthesia providers and obstetricians caring for the subject will be absent for the educational video and post-video conversation.

No Intervention: Hispanic Control
Hispanic subjects that receive standard of care [44 patients]
Experimental: Non-Hispanic Intervention
Non-Hispanic subjects that receive additional epidural education [44 patients]
Behavioral: Additional Epidural Education
All women allocated to receive additional epidural educational will be given a language appropriate pamphlet and video on neuraxial anesthesia. The video and pamphlet will be in the subject's primary language. After the subject watches the educational video they will be given an opportunity to go through the pamphlet with the research assistant and ask any questions they may have. For Spanish-speaking subjects this will occur through a telephone interpreter. The obstetric anesthesia providers and obstetricians caring for the subject will be absent for the educational video and post-video conversation.

No Intervention: Non-Hispanic Control
Non-Hispanic subjects that receive standard of care [44 patients].



Primary Outcome Measures :
  1. Epidural usage rate [ Time Frame: 1 year ]
    The primary aim of this study is to determine if women that receive focused education on epidural labor pain management in the form of a pamphlet and video are more likely to decide to use an epidural. The investigators will also compare the effect of the intervention on hispanic women to the effect of the intervention on non-hispanic women.


Secondary Outcome Measures :
  1. Pre and post intervention Beliefs about Epidurals Questionnaire [ Time Frame: 1 year ]
    A secondary goal of this study is to determine if the intervention changes women's beliefs about epidural labor pain management



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Pregnant with a fetus > 24 weeks gestation
  • Medicaid insurance
  • ASA class 1 to 3
  • Arriving at OHSU in spontaneous labor, requiring induction, or receiving augmentation of labor

Exclusion Criteria:

  • Patients having scheduled cesarean sections
  • Patients with conditions that are contraindications for epidural labor analgesia
  • Patients in whom epidural analgesia is mandated by the medical team
  • Patients delivering with a midwife

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): NCT02672397


Locations
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United States, Oregon
OHSU Labor and Delivery; Oregon Health and Science University Hospital
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Brandon M Togioka, MD Oregon Health and Science University
Publications:
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Responsible Party: Brandon Togioka, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02672397    
Other Study ID Numbers: IRB00010975
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Brandon Togioka, Oregon Health and Science University:
Epidural
Ethnicity
Education
Labor
obstetrical analgesia
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations