Brief Mindfulness for Foot and Ankle Pain

NCT ID: NCT05939843

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-12

Study Completion Date

2023-07-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pain Coping Information

Group Type ACTIVE_COMPARATOR

Pain Coping Information

Intervention Type BEHAVIORAL

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

Mindfulness Practice (alone)

Group Type EXPERIMENTAL

Mindfulness Practice (alone)

Intervention Type BEHAVIORAL

A 3-minute audio-guided mindfulness practice.

Mindfulness Introduction + Mindfulness Practice

Group Type EXPERIMENTAL

Mindfulness Introduction + Mindfulness Practice

Intervention Type 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

Group Type EXPERIMENTAL

Pain Introduction + Mindfulness Introduction + Mindfulness Practice

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pain Coping Information

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

Intervention Type BEHAVIORAL

Mindfulness Practice (alone)

A 3-minute audio-guided mindfulness practice.

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Utah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adam Hanley

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB_00085446 2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PROMIS and Patient Satisfaction
NCT04654910 COMPLETED NA
The Effect of Insoles in Plantar Fasciitis
NCT06563492 NOT_YET_RECRUITING NA