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Completed

NCT Number: NCT06952049

Does Psychoeducation Improve the Pain Relief Derived From a Brief Intervention

This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.

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Key information

Conditions

Pain Acute 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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Receiving pain treatment at Tallahassee Orthopedic Center
  • Understanding English instructions fluently
  • Being 18 years of age or older

Exclusion criteria

  • Unable to consent because of physical or mental incapacity.

Treatment and study plan

Pain Psychoeducation

Behavioral

In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.

Mindfulness without Psychoeducation

Behavioral

In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.

1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)

Behavioral

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.

1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)

Behavioral

In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.

2 Minutes of Psychoeducation with 1 Minute of Mindfulness

Behavioral

In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Time frame: Immediately before to after 3-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. Change in Pain Intensity Numeric Rating Scale

    Time frame: Immediately before to after 3-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. Change in Anxiety Numeric Rating Scale

    Time frame: Immediately before to after 3-minute audio recording

    Change in anxiety from baseline will be assessed a single item adapted from the Generalized Anxiety Disorder-2. Scores range from 0 to 10, with higher scores reflecting greater anxiety.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Does Psychoeducation Improve the Pain Relief Derived From a Brief Mindfulness-Based Intervention Delivered in a Clinic Waiting Room

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2025
Registry last updated
Feb 27, 2026

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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