PainNCT06582758
Does Choice Improve the Pain Relief Derived From a Brief Intervention
A study testing Pain Psychoeducation and Mindful Pain Management in people with Pain and Acute Pain, run by Florida State University at 1 site in United States.
Trial summary
This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute Pain
- What is being tested?
- Pain Psychoeducation and Mindful Pain Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2024to 25 Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Receiving pain treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
- Being 18 years of age or older
Who cannot join
- Unable to consent because of physical or mental incapacity.
Trial locations and contacts
1 site in 1 country.
United States1 site
Tallahassee Orthopedic Clinic (TOC)
Tallahassee, Florida, 32308
About this study
Official title: Brief (<10 Minute) Behavioral Interventions for Pain
This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.
Read the detailed description
This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.
- Conditions
- Pain, Acute Pain
- Being tested
- Pain Psychoeducation, Mindful Pain Management
- Keywords
- mindfulness
- Medical subject headings
- Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain PsychoeducationBehavioural
In the pain psychoeducation intervention, participants will be provided a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.
Mindful Pain ManagementBehavioural
In the mindful pain management intervention, participants will listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice.
| Study group | Role | What they receive |
|---|---|---|
| Mindful Pain Management (randomized) | Experimental | In the control mindful pain management intervention, participants will be randomized to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice. Receives: Behavioral: Mindful Pain Management |
| Pain Psychoeducation (randomized) | Active comparator | In the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being. Receives: Behavioral: Pain Psychoeducation |
| Choice: Mindful Pain Management | Experimental | In the choice mindful pain management intervention, participants will choose to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice. Receives: Behavioral: Mindful Pain Management |
| Choice: Pain Psychoeducation | Active comparator | In the choice pain psychoeducation intervention, participants will choose to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being. Receives: Behavioral: Pain Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Unpleasantness Numeric Rating Scale
Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.
Measured: Immediately before to after 7 to 10-minute audio recording
Secondary outcomes (2)
Change in Pain Intensity Numeric Rating Scale
Change in acute pain intensity will be measured with an individual item ("How much pain do you have, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity.
Measured: Immediately before to after 7 to 10-minute audio recording
Change in Anxiety Numeric Rating Scale
Change in anxiety from baseline will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety.
Measured: Immediately before to after 7 to 10-minute audio recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start4 Sep 2024
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Hanley, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582758
- Sponsor's protocol ID
- STUDY00004916_MOD5065
- Status last verified
- Mar 2025
- First submitted
- 30 Aug 2024
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief (<10 Minute) Behavioral Interventions for Pain
- ClinicalTrials.gov ID
- NCT06582758
- Acronym / sponsor ID
- STUDY00004916_MOD5065
- Conditions
- Pain, Acute Pain
- Keywords
- mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 3 Sep 2024 (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 project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience.
Detailed description
This project is a single-site, four-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room the ability to choose which pain management intervention the receive impacts the degree of pain relief they experience. Participants will be randomized to one of three conditions: 1) a 4-minute pain psychoeducation recording, 2) a 4-minute mindfulness recording, or 3) choice. In the choice condition, participants will be able to choose which recoding (i.e., pain psychoeducation or mindfulness) they would like to listen to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mindful Pain Management (randomized) | Experimental | Behavioral: Mindful Pain ManagementIn the control mindful pain management intervention, participants will be randomized to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice. |
| Pain Psychoeducation (randomized) | Active comparator | Behavioral: Pain PsychoeducationIn the pain psychoeducation intervention, participants will be randomized to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being. |
| Choice: Mindful Pain Management | Experimental | Behavioral: Mindful Pain ManagementIn the choice mindful pain management intervention, participants will choose to listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice. |
| Choice: Pain Psychoeducation | Active comparator | Behavioral: Pain PsychoeducationIn the choice pain psychoeducation intervention, participants will choose to listen to a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Receiving pain treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
- Being 18 years of age or older
Key exclusion criteria (1 listed)
- Unable to consent because of physical or mental incapacity.
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 |
|---|---|---|
| Pain PsychoeducationIn the pain psychoeducation intervention, participants will be provided a four-minute recording about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being. | Behavioural | Choice: Pain Psychoeducation, Pain Psychoeducation (randomized) |
| Mindful Pain ManagementIn the mindful pain management intervention, participants will listen to a four minute mindfulness intervention consisting of a 1-minute introduction to mindful pain management and a 3-minute mindfulness practice. | Behavioural | Choice: Mindful Pain Management, Mindful Pain Management (randomized) |
Primary outcome
Change in Pain Unpleasantness Numeric Rating Scale
Time frame: Immediately before to after 7 to 10-minute audio recording
Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.
2 secondary outcomes
Change in Pain Intensity Numeric Rating Scale
Time frame: Immediately before to after 7 to 10-minute audio recording
Change in Anxiety Numeric Rating Scale
Time frame: Immediately before to after 7 to 10-minute audio recording
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 Mar 2025.
- Individual participant dataSharing planned: No
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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 Pain Psychoeducation and Mindful Pain Management in people with Pain and Acute Pain, run by Florida State University 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 1 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 Mar 2025. 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. 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?
Change in Pain Unpleasantness Numeric Rating Scale (time frame: Immediately before to after 7 to 10-minute audio recording). 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 Mar 2025.