Brief Mindfulness Intervention for Orthopedic Patients

NCT06099964 | Completed

• 1 other identifier: IRB_00085446 2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Pain Intensity Numeric Rating Scale

  Immediately before to after 4-minute audio recording

• Change in Anxiety Numeric Rating Scale

  Immediately before to after 4-minute audio recording

• Change in Depression Numeric Rating Scale

  Immediately before to after 4-minute audio recording]

Study Arms (2)

Pain Coping Information

ACTIVE COMPARATOR

Participants will be randomized to listen to a 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

Behavioral: Pain Coping Information

Mindful Pain Management

EXPERIMENTAL

Participants will be randomized to listen to 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.

Behavioral: Mindful Pain Management

Interventions

Pain Coping Information BEHAVIORAL

A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

Pain Coping Information

Mindful Pain Management BEHAVIORAL

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.

Mindful Pain Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Seeking foot or ankle treatment at the Tallahassee Orthopedic Center

You may not qualify if:

• Cognitive impairment preventing completion of study procedures.
• Current cancer diagnosis,
• Other unstable illness judged by medical staff to interfere with study involvement.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, 32308, United States

Location

Related Publications (1)

• Hanley AW, Wilson Zingg R, Smith B, Zappa M, White S, Davis A, Worts PR, Culjat C, Martorella G. Mindfulness in the Clinic Waiting Room May Decrease Pain: Results from Three Pilot Randomized Controlled Trials. J Integr Complement Med. 2024 Nov;30(11):1082-1091. doi: 10.1089/jicm.2024.0020. Epub 2024 May 17.

  PMID: 38757714 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 25, 2023
• Study Start: November 13, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)