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OpenTrials
Completed

NCT Number: NCT06099964

Brief Mindfulness Intervention for Orthopedic Patients

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

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Key information

Conditions

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: Yes

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

Inclusion criteria

  • Age ≥18
  • Seeking foot or ankle treatment at the Tallahassee Orthopedic Center

Exclusion criteria

  • • Cognitive impairment preventing completion of study procedures.
  • Current cancer diagnosis,
  • Other unstable illness judged by medical staff to interfere with study involvement.

Treatment and study plan

Pain Coping Information

Behavioral

A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

Mindful Pain Management

Behavioral

A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Time frame: Immediately before to after 4-minute audio recording

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

Secondary outcomes

  1. Change in Pain Intensity Numeric Rating Scale

    Time frame: Immediately before to after 4-minute audio recording

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

  2. Change in Anxiety Numeric Rating Scale

    Time frame: Immediately before to after 4-minute audio recording

    Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety.

  3. Change in Depression Numeric Rating Scale

    Time frame: Immediately before to after 4-minute audio recording]

    Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 indicating severe depression.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Official study title

Brief Mindfulness Intervention for a Heterogenous Mix of Orthopedic Patients

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 25, 2023
Registry last updated
Jun 19, 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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