Brief Mindfulness for Foot and Ankle Pain

NCT05939843 | Completed

• 1 other identifier: IRB_00085446 2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Pain Intensity Numeric Rating Scale

  Immediately before to after 3-minute audio recording

• Change in Pain Medication Desire Numeric Rating Scale

  Immediately before to after 3-minute audio recording

Other Outcomes (1)

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

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

Study Arms (4)

Pain Coping Information

ACTIVE COMPARATOR

Behavioral: Pain Coping Information

Mindfulness Practice (alone)

EXPERIMENTAL

Behavioral: Mindfulness Practice (alone)

Mindfulness Introduction + Mindfulness Practice

EXPERIMENTAL

Behavioral: Mindfulness Introduction + Mindfulness Practice

Pain Introduction + Mindfulness Introduction + Mindfulness Practice

EXPERIMENTAL

Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice

Interventions

Pain Coping Information BEHAVIORAL

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

Pain Coping Information

Mindfulness Practice (alone) BEHAVIORAL

A 3-minute audio-guided mindfulness practice.

Mindfulness Practice (alone)

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

Mindfulness Introduction + 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

Pain Introduction + Mindfulness Introduction + Mindfulness Practice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Seeking foot or ankle treatment at the University Orthopaedic Center

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Single Person

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 11, 2023
• Study Start: July 12, 2023
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

US (1)