Brief Mindfulness for Foot and Ankle Pain

Not Applicable

Recruiting

• Conditions: Pain
• Interventions: Behavioral: Mindfulness Introduction + Mindfulness Practice; Behavioral: Pain Coping Information; Behavioral: Mindfulness Practice (alone); Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice

• Registration Number: NCT05939843
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-11
• Study Start: 2023-07-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Introduction + Mindfulness Practice	Mindfulness Introduction + Mindfulness Practice	-
Pain Coping Information	Pain Coping Information	-
Mindfulness Practice (alone)	Mindfulness Practice (alone)	-
Pain Introduction + Mindfulness Introduction + Mindfulness Practice	Pain Introduction + Mindfulness Introduction + Mindfulness Practice	-

Primary Outcome Measures

Name	Time	Method
Change in Pain Unpleasantness Numeric Rating Scale	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 Outcome Measures

Name	Time	Method
Change in Pain Medication Desire Numeric Rating Scale	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.
Change in Pain Intensity Numeric Rating Scale	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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States