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NCT Number: NCT06471075

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

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.

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Key information

Conditions

Pain Acute Pain Chronic Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, 32308, United States

Location status: Recruiting

Location contact

Emilie Miley, Ph.D.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindful Pain Management

Behavioral

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

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Acute Pain

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

    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.

  2. Anxiety

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

    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.

  3. Treatment Satisfaction

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Adam W Hanley, Ph.D.

CONTACT

[email protected]

850-644-2647

Allison R Davis, M.S.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Brief (i.e., <10 Minute) Behavioral Intervention for Pain

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2024
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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