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

Sponsor
University of Pittsburgh (Other)
Overall Status
Completed
CT.gov ID
NCT04308655
Collaborator
(none)
33
1
24.8
1.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Interview
  • Other: Surveys

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
33 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Obstetric Pain Management for Women With Opioid Use Disorder: A Longitudinal, Qualitative Mixed-methods Evaluation of Patients and Provider Perspectives
Actual Study Start Date :
Mar 6, 2020
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
Mar 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Other: Interview
Semi-structured interviews

Other: Surveys
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.

Other: Interview
Semi-structured interviews

Outcome Measures

Primary Outcome Measures

  1. Themes surrounding mothers' pain/recover experience [Through study completion, an average of 6 weeks (from enrollment through labor and delivery)]

    The endpoint of this mixed-methods investigation is to identify themes surrounding mothers' pain/recovery experiences that correlate with quantified pain and analgesic needs. Endpoint will take the form of words/terms, phrases, or sentences. Identification of these terms, phases, or sentences are not identified a priori in this qualitative investigation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UPMC Magee Womens Hospital Pittsburgh Pennsylvania United States 15215

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

  • Principal Investigator: Grace Lim, MD MS, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Grace Lim, MD, MS, Primary Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT04308655
Other Study ID Numbers:
  • STUDY20010041
First Posted:
Mar 16, 2020
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022