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
  • Behavioral: Mindfulness
  • Other: Education
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

  1. 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

  1. 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:

Study Results

No Results Posted as of Dec 21, 2022