Brief Mindfulness for Foot and Ankle Pain

Pain Clinical Trial

Official title:

Brief Mindfulness for Foot and Ankle Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05939843
• Other study ID #: IRB_00085446 2
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: University of Utah
• Contact: Adam W Hanley
• Phone: (801) 213-4191
• Email: adam.hanley[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

Behavioral:
• Pain Coping Information
A three minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery)
• Mindfulness Practice (alone)
A 3-minute audio-guided mindfulness practice.
• Mindfulness Introduction + Mindfulness Practice
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
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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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
Secondary	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