A Brief Intervention for Patients on Opioids for Acute Pain
Sponsor
Henry Ford Health System (Other)
Overall Status
Completed
CT.gov ID
NCT05658926
Collaborator
(none)
60
1
2
7.9
7.6
Study Details
Study Description
Brief Summary
This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Brief Intervention for Patients on Opioids for Acute Pain
Actual Study Start Date
:
Sep 1, 2017
Actual Primary Completion Date
:
Mar 31, 2018
Actual Study Completion Date
:
Apr 30, 2018
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Intervention Participants will learn a brief, mindfulness skill |
Behavioral: Mindfulness
Patients will learn how to use diaphragmatic breathing with mindfulness
|
Placebo Comparator: Education Participants will receive education about the effects of emotions on pain |
Other: Education
Patients will be provided with education regarding the Gate Control Theory of Pain.
|
Outcome Measures
Primary Outcome Measures
- Pain severity [Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart.]
Pain severity rated on a 0-10 scale
Secondary Outcome Measures
- Stress level [Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart]
Stress level rated on a 0-10 scale
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients who are admitted to Henry Ford Hospital
-
Patients who have been evaluated by the Psychosomatic Medicine Service
-
Patients who are prescribed at least one opioid for an acute pain condition
Exclusion Criteria:
-
Patients taking an opioid for a chronic pain condition within the previous year
-
History of an opioid use disorder.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Henry Ford Health System | Detroit | Michigan | United States | 48083 |
Sponsors and Collaborators
- Henry Ford Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Lisa Matero,
Senior Staff Psychologist,
Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT05658926
Other Study ID Numbers:
- HFHS Acute Pain
First Posted:
Dec 21, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: