Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation

Pain Clinical Trial

Official title:

Brief Mindfulness Intervention for Orthopedic Patients in the Clinic Waiting Room: Mechanistic Investigation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06171009
• Other study ID #: STUDY00004419
• Status: Suspended
• Phase: N/A
• Start date: December 7, 2024
• Est. completion date: March 7, 2025

Study information

• Verified date: December 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The analgesic 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. Analgesic mechanisms of mindfulness will also be investigated.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: March 7, 2025
• Est. primary completion date: March 7, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18
• Seeking treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

• Cognitive impairment preventing completion of study procedures.
• 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 Decentering	Decentering will be measured by the single, decentering item from the state version of the validated Metacognitive Processes of Decentering Scale. This item will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater decentering.	Immediately before to after 4-minute audio recording
Secondary	Change in Self-Transcendent State	Self-transcendent state will be measured by the three-item, state version of the validated Nondual Awareness Dimensional Assessment. These three items will be scored with a Likert scale item ranging from 0-10, with higher scores representing greater self-transcendence.	Immediately before to after 4-minute audio recording