A Brief Intervention for Patients on Opioids for Acute Pain

December 9, 2022 updated by: Lisa Matero, Henry Ford Health System
This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

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

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48083
        • Henry Ford Health System

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain severity
Time Frame: 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
Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress level
Time Frame: 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
Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry Ford Health System

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)

September 1, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

December 9, 2022

First Posted (Actual)

December 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 9, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HFHS Acute Pain

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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