NCT05658926

Brief Summary

This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

July 31, 2017

Last Update Submit

December 9, 2022

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (1)

  • Pain severity

    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 Outcomes (1)

  • Stress level

    Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will learn a brief, mindfulness skill

Behavioral: Mindfulness

Education

PLACEBO COMPARATOR

Participants will receive education about the effects of emotions on pain

Other: Education

Interventions

MindfulnessBEHAVIORAL

Patients will learn how to use diaphragmatic breathing with mindfulness

Intervention
EducationOTHER

Patients will be provided with education regarding the Gate Control Theory of Pain.

Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients taking an opioid for a chronic pain condition within the previous year
  • History of an opioid use disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48083, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

MindfulnessEducational Status

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Psychologist

Study Record Dates

First Submitted

July 31, 2017

First Posted

December 21, 2022

Study Start

September 1, 2017

Primary Completion

March 31, 2018

Study Completion

April 30, 2018

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

US(1)