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

Opioid-use Disorder Clinical Trial

— QUEST  

Official title:

Obstetric Pain Management for Women With Opioid Use Disorder: A Longitudinal, Qualitative Mixed-methods Evaluation of Patients and Provider Perspectives

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308655
• Other study ID #: STUDY20010041
• Status: Completed
• Start date: March 6, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 31, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

Other:
• Interview
Semi-structured interviews
• Surveys
Validated surveys on pain, fear, anxiety, depression, beliefs

Locations

Country	Name	City	State
United States	UPMC Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Themes surrounding mothers' pain/recover experience	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.	Through study completion, an average of 6 weeks (from enrollment through labor and delivery)