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Completed

NCT Number: NCT05939843

Brief Mindfulness for Foot and Ankle Pain

This is a single-site, four-arm, parallel-group randomized clinical trial (RCT). The clinical effects of three different formats of a very brief (i.e., 3 minute), audio-recorded mindfulness intervention for foot and ankle patients will be investigated relative to a 3-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

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18
  • Seeking foot or ankle treatment at the University Orthopaedic 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 three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery)

Mindfulness Practice (alone)

Behavioral

A 3-minute audio-guided mindfulness practice.

Mindfulness Introduction + Mindfulness Practice

Behavioral

A 1-minute audio-recorded introduction to the practice of mindfulness followed by a 2-minute audio-guided mindfulness practice

Pain Introduction + Mindfulness Introduction + Mindfulness Practice

Behavioral

A 1-minute audio-recorded introduction to pain, followed by a 1-minute audio-recorded introduction the practice of mindfulness, followed by a 1-minute audio-guided mindfulness practice

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Time frame: Immediately before to after 3-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 3-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 Pain Medication Desire Numeric Rating Scale

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

    Single Likert scale item ranging from 0-10, with 0 indicating no desire for pain medication and 10 representing a strong desire for pain medication.

Other outcomes

  1. Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0

    Time frame: From before the patient's intervention visit to their subsequent re-evaluation. This time span is typically around 6 weeks.

    The PROMIS physical functioning computer assisted test draws from a bank of 123 items all scored on a 5 point Likert scale.

    T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score better physical functioning.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 11, 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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