- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03018782
Pain Screening in Refugee Survivors of Torture
July 17, 2021 updated by: Weill Medical College of Cornell University
The Implementation of a Novel Pain-screening Tool in the Diagnoses of Pain Symptoms and Syndromes in Refugee Survivors of Torture
The investigators are evaluating refugee torture survivors who are receiving services at the Weill Cornell Center for Human Rights.
There are two research questions in this study: if the current standard of care results in the under or missed diagnosis of pain and pain syndromes, and if a validated pain screening tool can supplement the current standard protocol used in the assessments of survivors of torture.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research plan consists of three components:
- The Weill Cornell Center for Human Rights will coordinate with the research team regarding eligible subjects.
- Researchers will contact potential subjects utilizing interpreter services.
- Interested participants will be scheduled for an appointment for an examination by a pain physician and to complete the Brief Pain Inventory.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Weill Cornell Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women from any country over the age of 18
- refugees receiving services from the Weill Cornell Center for Human Rights
Exclusion Criteria:
- Have not experienced torture
- Subjects whose representative does not believe that they are a good candidate for the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Brief Pain Inventory Short Form
Completes the Brief Pain Inventory Short Form
|
Brief Pain Inventory Short Form
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with chronic pain or pain syndromes as assessed by a non-invasive pain evaluation conducted by a pain physician
Time Frame: Day 1
|
Evaluate whether or not current standard protocols for the assessment of survivors of torture result in under or missed diagnosis of pain and pain syndromes that are identifiable by a pain specialist physician
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with chronic pain or pain syndromes as assessed by the Brief Pain Inventory (BPI) Short Form
Time Frame: Day 1
|
Evaluate whether or not a validated pain screening tool can supplement the current standard protocols used in the assessment of survivors of torture.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Eliana Weinstein, BS, Weill Medical College of Cornell University
- Principal Investigator: Gunisha Kaur, MD, Weill Medical College of Cornell University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
June 21, 2019
Study Completion (Actual)
June 21, 2019
Study Registration Dates
First Submitted
December 17, 2016
First Submitted That Met QC Criteria
January 10, 2017
First Posted (Estimate)
January 12, 2017
Study Record Updates
Last Update Posted (Actual)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 17, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1608017472
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to make individual participant data available to other researchers
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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