Back to resultsA Brief Intervention for Patients on Opioids for Acute Pain
Primary Purpose
Acute Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness
Education
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
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.
Sites / Locations
- Henry Ford Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Education
Arm Description
Participants will learn a brief, mindfulness skill
Participants will receive education about the effects of emotions on pain
Outcomes
Primary Outcome Measures
Pain severity
Pain severity rated on a 0-10 scale
Secondary Outcome Measures
Stress level
Stress level rated on a 0-10 scale
Full Information
NCT ID
NCT05658926
First Posted
July 31, 2017
Last Updated
December 9, 2022
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT05658926
Brief Title
A Brief Intervention for Patients on Opioids for Acute Pain
Official Title
A Brief Intervention for Patients on Opioids for Acute Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
March 31, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will learn a brief, mindfulness skill
Arm Title
Education
Arm Type
Placebo Comparator
Arm Description
Participants will receive education about the effects of emotions on pain
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Intervention Description
Patients will learn how to use diaphragmatic breathing with mindfulness
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Patients will be provided with education regarding the Gate Control Theory of Pain.
Primary Outcome Measure Information:
Title
Pain severity
Description
Pain severity rated on a 0-10 scale
Time Frame
Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart.
Secondary Outcome Measure Information:
Title
Stress level
Description
Stress level rated on a 0-10 scale
Time Frame
Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48083
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Brief Intervention for Patients on Opioids for Acute Pain
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