Brief Mindfulness for Foot and Ankle Pain

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Pain

Treatments: Behavioral: Mindfulness Introduction + Mindfulness Practice; Behavioral: Pain Coping Information; Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice; Behavioral: Mindfulness Practice (alone)

Study type: Interventional

Funder types: Other

Identifiers

NCT05939843

IRB_00085446 2

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 4 patient groups

Pain Coping Information

Active Comparator group

Treatment:

Behavioral: Pain Coping Information

Mindfulness Practice (alone)

Experimental group

Treatment:

Behavioral: Mindfulness Practice (alone)

Mindfulness Introduction + Mindfulness Practice

Experimental group

Treatment:

Behavioral: Mindfulness Introduction + Mindfulness Practice

Pain Introduction + Mindfulness Introduction + Mindfulness Practice

Experimental group

Treatment:

Behavioral: Pain Introduction + Mindfulness Introduction + Mindfulness Practice