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RecruitingNCT06471075Updated Sep 15, 2026

Brief Mindfulness Intervention for Pain Before an In-clinic Orthopedic Procedure

An interventional study of Mindful Pain Management and Pain Psychoeducation in Pain, Chronic Pain and Acute Pain, sponsored by Florida State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 14 studies in Pain by Florida State University — 3 open to participants now, 3 under way, none of them phase 3. Pain · Florida State University.

Planned enrollment
10th of 14
80 · median 99
Started
2024
with 5 others
No phase
14 of 14
3 open now
Registered
7th of 14
by date

Among the 14 studies in Pain by Florida State University, this one is the 10th largest by planned enrollment, is one of 6 that started in 2024, is one of 14 with no phase, and was the 7th registered.

By phase

14 studies; the count open now beside each. This study's row is marked.

No phasethis study14 · 3 open

By the year they started

First in 2018; this study’s year is marked. 6 started in 2024.

Size and results

Median enrollment 99 across the 14 interventional studies. Of the 11 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 14 studies in Pain by Florida State University, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Pain
  • Chronic Pain
  • Acute Pain

Keywords

  • mindfulness
  • kyphoplasty
  • radiofrequency ablation
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Undergoing Kyphoplasty or Radiofrequency Ablation at Tallahassee Orthopedic Center
  • Fluency with English
  • Being 18 and above

Exclusion criteria

Exclusion Criteria:

  • Unable to consent because of physical or mental incapacity.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Mindfulness Pain Management

    Behavioral: Mindful Pain Management

  • Active comparator
    Pain Psychoeducation

    Behavioral: Pain Psychoeducation

Interventions

  • BehavioralMindful Pain Management

    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.

  • BehavioralPain Psychoeducation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Immediately before to after 7-minute audio recording

Secondary outcomes

  1. 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.

    Time frame: Immediately before to after 7-minute audio recording

  2. 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.

    Time frame: Immediately before to after 7-minute audio recording

  3. 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

    Time frame: At the end of the medical provider visit - approximately 1 hour.

07

Study locations

1 of 1 sites recruiting
  • Tallahassee Orthopedic Clinic (TOC)
    Tallahassee, Florida 32308, United States
    Recruiting
    • Emilie Miley, Ph.D. · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Sep 2027, 36 months after the start.

Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 36 months is above that.

Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 13, 2024
First posted
Jun 24, 2024
StartActual
Aug 22, 2024
Primary completionEst.
Sep 11, 2027
CompletionEst.
Sep 11, 2027
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06471075
Responsible party
Adam Hanley (Associate Professor, Florida State University) — Principal investigator
First posted
Jun 24, 2024
Start date
Aug 22, 2024
Primary completion
Sep 11, 2027 (estimated)
Completion
Sep 11, 2027 (estimated)
Last update
Sep 15, 2026

Study contacts

Adam W Hanley, Ph.D.
Contact
adam.hanley@fsu.edu
850-644-2647
Allison R Davis, M.S.
Contact
ad23cm@fsu.edu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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