PainNCT06471075
Brief Mindfulness Intervention for Pain Before an In-clinic Orthopedic Procedure
A study testing Mindful Pain Management and Pain Psychoeducation in people with Pain and Chronic Pain, run by Florida State University at 1 site in United States.
Trial summary
This project is a single-site, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Chronic Pain, Acute Pain
- What is being tested?
- Mindful Pain Management and Pain Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2024to 11 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Undergoing Kyphoplasty or Radiofrequency Ablation at Tallahassee Orthopedic Center
- Fluency with English
- Being 18 and above
Who cannot join
- Unable to consent because of physical or mental incapacity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Allison R Davis, M.S. contact
United States1 site, 1 recruiting
- Recruiting
Tallahassee Orthopedic Clinic (TOC)
Tallahassee, Florida, 32308
Emilie Miley, Ph.D.
About this study
Official title: Brief (i.e., <10 Minute) Behavioral Intervention for Pain
This project is a single-site, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation.
- Conditions
- Pain, Chronic Pain, Acute Pain
- Being tested
- Mindful Pain Management, Pain Psychoeducation
- Keywords
- mindfulness, kyphoplasty, radiofrequency ablation
- Medical subject headings
- Pain, Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Pain ManagementBehavioural
The mindfulness intervention will involve a 2-minute introduction to mindfulness as a technique for pain management followed by a 5-minute, audio-guided, mindful breathing practice.
Pain PsychoeducationBehavioural
In the pain psychoeducation intervention, participants will be provided timematched information about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Pain Management | Experimental | Not described Receives: Behavioral: Mindful Pain Management |
| Pain Psychoeducation | Active comparator | Not described 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-minute audio recording
Secondary outcomes (3)
Acute Pain
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-minute audio recording
Anxiety
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-minute audio recording
Treatment Satisfaction
Treatment satisfaction at the visit's end will be measured with three, validated items (1. How satisfied are you with your medical care today?, 2. Was the visit/procedure tolerable?, 3. Would you have the same procedure again?), each scored on an 11-point, Likert-type scale ranging from 0 to 10. Higher scores represent greater treatment satisfaction
Measured: At the end of the medical provider visit - approximately 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start22 Aug 2024
- Primary completion11 Sep 2027 (estimated)
- Study completion11 Sep 2027 (estimated)
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
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
- NCT06471075
- Sponsor's protocol ID
- STUDY00004916
- Status last verified
- Sep 2026
- First submitted
- 13 Jun 2024
- Last updated
- 15 Sep 2026
- 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief (i.e., <10 Minute) Behavioral Intervention for Pain
- ClinicalTrials.gov ID
- NCT06471075
- Acronym / sponsor ID
- STUDY00004916
- Conditions
- Pain, Chronic Pain, Acute Pain
- Keywords
- mindfulness, kyphoplasty, radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- 11 Sep 2027 (estimated)
- Study completion
- 11 Sep 2027 (estimated)
- First posted
- 24 Jun 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, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Pain Management | Experimental | Behavioral: Mindful Pain Management |
| Pain Psychoeducation | Active comparator | Behavioral: Pain Psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing Kyphoplasty or Radiofrequency Ablation at Tallahassee Orthopedic Center
- Fluency with English
- Being 18 and above
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 |
|---|---|---|
| Mindful Pain ManagementThe mindfulness intervention will involve a 2-minute introduction to mindfulness as a technique for pain management followed by a 5-minute, audio-guided, mindful breathing practice. | Behavioural | Mindfulness Pain Management |
| Pain PsychoeducationIn the pain psychoeducation intervention, participants will be provided timematched information about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being. | Behavioural | Pain Psychoeducation |
Primary outcome
Change in Pain Unpleasantness Numeric Rating Scale
Time frame: Immediately before to after 7-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.
3 secondary outcomes
Acute Pain
Time frame: Immediately before to after 7-minute audio recording
Anxiety
Time frame: Immediately before to after 7-minute audio recording
Treatment Satisfaction
Time frame: At the end of the medical provider visit - approximately 1 hour.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- 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.
Allison R Davis, M.S. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Pain Management and Pain Psychoeducation in people with Pain and Chronic 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam W Hanley, Ph.D. (850-644-2647, adam.hanley@fsu.edu), or a site near the patient. 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-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 15 Sep 2026.