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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Behavioral: Pain Coping Information; Behavioral: Mindfulness Practice (alone); Behavioral: Mindfulness Introduction + Mindfulness Practice; Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pain Coping Information	Behavioral: Pain Coping Information; A three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery)
Experimental: Mindfulness Practice (alone)	Behavioral: Mindfulness Practice (alone); A 3-minute audio-guided mindfulness practice.
Experimental: Mindfulness Introduction + Mindfulness Practice	Behavioral: Mindfulness Introduction + Mindfulness Practice; A 1-minute audio-recorded introduction to the practice of mindfulness followed by a 2-minute audio-guided mindfulness practice
Experimental: Pain Introduction + Mindfulness Introduction + Mindfulness Practice	Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Unpleasantness Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.	Immediately before to after 3-minute audio recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.	Immediately before to after 3-minute audio recording
Change in Pain Medication Desire Numeric Rating Scale	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.	Immediately before to after 3-minute audio recording

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0	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.	From before the patient's intervention visit to their subsequent re-evaluation. This time span is typically around 6 weeks.

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00085446 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No