- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04308655
Obstetric Pain Management for Women With Opioid Use Disorder (QUEST) (QUEST)
Obstetric Pain Management for Women With Opioid Use Disorder: A Longitudinal, Qualitative Mixed-methods Evaluation of Patients and Provider Perspectives
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Förenta staterna, 15215
- UPMC Magee Womens Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
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Semi-structured interviews
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.
|
Semi-structured interviews
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Themes surrounding mothers' pain/recover experience
Tidsram: Through study completion, an average of 6 weeks (from enrollment through labor and delivery)
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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)
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Grace Lim, MD MS, University of Pittsburgh
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY20010041
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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