Acute PainNCT05658926
A Brief Intervention for Patients on Opioids for Acute Pain
A study testing Mindfulness and Education in people with Acute Pain, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Pain
- What is being tested?
- Mindfulness and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients taking an opioid for a chronic pain condition within the previous year
- History of an opioid use disorder.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.
- Conditions
- Acute Pain
- Being tested
- Mindfulness, Education
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
Patients will learn how to use diaphragmatic breathing with mindfulness
EducationOther
Patients will be provided with education regarding the Gate Control Theory of Pain.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will learn a brief, mindfulness skill Receives: Behavioral: Mindfulness |
| Education | Placebo comparator | Participants will receive education about the effects of emotions on pain Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Pain severity rated on a 0-10 scale
Measured: 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
Stress level rated on a 0-10 scale
Measured: Change from pre- to post-intervention. The intervention is approximately 10 minutes so the measurements are taken about 10 minutes apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Sep 2017
- Primary completion31 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Matero, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658926
- Sponsor's protocol ID
- HFHS Acute Pain
- Status last verified
- Dec 2022
- First submitted
- 31 Jul 2017
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention for Patients on Opioids for Acute Pain
- ClinicalTrials.gov ID
- NCT05658926
- Acronym / sponsor ID
- HFHS Acute Pain
- Conditions
- Acute Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate benefits of a brief intervention for patients who are prescribed opioids for acute pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MindfulnessParticipants will learn a brief, mindfulness skill |
| Education | Placebo comparator | Other: EducationParticipants will receive education about the effects of emotions on pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients taking an opioid for a chronic pain condition within the previous year
- History of an opioid use disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindfulnessPatients will learn how to use diaphragmatic breathing with mindfulness | Behavioural | Intervention |
| EducationPatients will be provided with education regarding the Gate Control Theory of Pain. | Other | Education |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Education in people with Acute Pain, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.