Recruiting

Mindfulness Intervention

Sponsor:

Florida State University

Code:

NCT06471075

Conditions

Pain

Chronic Pain

Acute Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindful Pain Management

Pain Psychoeducation

Study Details

Brief 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.

Conditions

Pain

Chronic Pain

Acute Pain

Study ID

NCT06471075

Start date

Aug 22, 2024

Status verified date

Sep, 2025

Completion date

Sep 11, 2026

Anticipated

Primary completion date

Sep 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Mindfulness Pain Management

active comparator: Pain Psychoeducation

Interventions

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.

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.

Primary outcome measure

  • Change in Pain Unpleasantness Numeric Rating Scale [ Time Frame: Immediately before to after 7-minute audio recording ]

Central Contacts and Locations

Central contacts

Adam W Hanley, Ph.D.

850-644-2647adam.hanley@fsu.edu

Allison R Davis, M.S.

ad23cm@fsu.edu

Locations

Tallahassee Orthopedic Clinic (TOC)

Recruiting

Tallahassee, Florida, United States, 32308

More Information

Sponsor

Florida State University

Last update posted

Sep 4, 2025

Last verified

Sep, 2025

Keywords

  • mindfulness
  • kyphoplasty
  • radiofrequency ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2025-09-04.