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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Chronic Pain; Acute Pain
• Intervention / Treatment: Behavioral: Pain Psychoeducation; Behavioral: Mindful Pain Management

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison R Davis, M.S.; Email: ad23cm@fsu.edu
• Study Contact Backup: Name: Adam W Hanley, Ph.D.; Phone Number: 850-644-2647; Email: adam.hanley@fsu.edu

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Recruiting
      • Tallahassee Orthopedic Clinic (TOC)
      • Contact: Emilie Miley, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Unable to consent because of physical or mental incapacity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Pain Management	Behavioral: Mindful 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.
Active Comparator: Pain Psychoeducation	Behavioral: Pain 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately before to after 7-minute audio recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	At the end of the medical provider visit - approximately 1 hour.

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2024
• Primary Completion (Estimated): September 11, 2026
• Study Completion (Estimated): September 11, 2026

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: radiofrequency ablation; mindfulness; kyphoplasty
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Chronic Pain; Acute Pain
• Other Study ID Numbers: STUDY00004916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No