Obstetric Pain Management for Women With Opioid Use Disorder (QUEST)

NCT ID: NCT04308655

Last Updated: 2022-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-06

Study Completion Date

2022-03-31

Brief Summary

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This is a mixed methods longitudinal observational study to assess patient and provider perspectives on pain and pain management among pregnant women with opiate use disorder (OUD). The findings from this study will inform patient-centered approaches to pain management. Themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesia endpoints will be identified. Findings will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD.

Detailed Description

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A fine understanding of the attitudes and beliefs about pain and its management for patients with opioid use disorder is currently lacking. These psychological aspects of pain and analgesia are expected to have significant effects on nociception, pain experience, analgesic efficacy, and opioid requirements and its subsequent risks for relapse/treatment noncompliance. There is also have little understanding of provider-held attitudes and beliefs which can influence pain and its treatment for this population.

The findings from this study will inform patient-centered approaches to pain management for obstetric patients with OUD. They will also shape an appropriate patient-centered research agenda for obstetric pain management in patients with OUD. This work will find new patient-centered endpoints for this special population that may be currently overlooked with existing standard pain assessments.

Conditions

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Opioid-use Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient participants

This cohort will include pregnant patients with a history of opiate use disorder (OUD) who will be followed from the third trimester of pregnancy until five days postpartum.

Interview

Intervention Type OTHER

Semi-structured interviews

Surveys

Intervention Type OTHER

Validated surveys on pain, fear, anxiety, depression, beliefs

Provider participants

This cohort will include clinicians who provide care for pregnant patients with OUD. Providers will be interviewed and will complete one survey cross-sectionally.

Interview

Intervention Type OTHER

Semi-structured interviews

Interventions

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Interview

Semi-structured interviews

Intervention Type OTHER

Surveys

Validated surveys on pain, fear, anxiety, depression, beliefs

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women who are 18 years of age or older
* History of opioid use disorder, on medication assisted therapy
* Currently in their third trimester

Exclusion Criteria

* Unable to participate in informed consent discussions
* Unable to give informed consent for any reason
* Not fluent in English (surveys are validated in English language)
* Unable to participate fully in all study procedures for any reason
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Grace Lim, MD, MS

Primary Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grace Lim, MD MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY20010041

Identifier Type: -

Identifier Source: org_study_id

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