Brief Mindfulness Intervention for Orthopedic Patients

Pain Clinical Trial

Official title:

Brief Mindfulness Intervention for a Heterogenous Mix of Orthopedic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099964
• Other study ID #: IRB_00085446 2
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: October 23, 2024

Study information

• Verified date: November 2023
• Source: Florida State University
• Contact: Adam W Hanley, PHD
• Phone: (801) 213-4191
• Email: awh10d[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 23, 2024
• Est. primary completion date: October 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18

• Seeking foot or ankle treatment at the Tallahassee Orthopedic 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 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
• Mindful Pain Management
A 4-minute audio recording consisting of a 1-minute introduction to mindfulness followed by a 1-minute and 30-second mindful breathing practice and a 1-minute and 30-second mindfulness of pain practice.

Locations

Country	Name	City	State
United States	Tallahassee Orthopedic Clinic (TOC)	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 4-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 4-minute audio recording
Secondary	Change in Anxiety Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety.	Immediately before to after 4-minute audio recording
Secondary	Change in Depression Numeric Rating Scale	Single Likert scale item ranging from 0-10, with 0 indicating no depression and 10 indicating severe depression.	Immediately before to after 4-minute audio recording]