Brief Mindfulness Intervention for Orthopedic Patients: Mechanistic Investigation
1 other identifier
interventional
158
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pain
Started May 2024
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2023
CompletedFirst Posted
Study publicly available on registry
December 14, 2023
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2024
CompletedSeptember 19, 2024
September 1, 2024
1 month
December 6, 2023
September 5, 2024
Conditions
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 Decentering
Immediately before to after 4-minute audio recording
Change in Self-Transcendent State
Immediately before to after 4-minute audio recording
Study Arms (2)
Pain Coping Information
ACTIVE COMPARATORMindful Pain Management
EXPERIMENTALInterventions
A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
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.
Eligibility Criteria
You may qualify if:
- Age ≥18
- Seeking treatment at the Tallahassee Orthopedic Center
You may not qualify if:
- Cognitive impairment preventing completion of study procedures.
- Other unstable illness judged by medical staff to interfere with study involvement.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tallahassee Orthopedic Clinic (TOC)
Tallahassee, Florida, 32308, United States
Related Publications (1)
Hanley AW, Gibson R, Davis A, Stecher C, Childs K, Worts P. Mindfulness in the Orthopedic Clinic Waiting Room Decreases Pain: Results From A Randomized Controlled Trial. Int J Behav Med. 2025 Nov 10. doi: 10.1007/s12529-025-10398-3. Online ahead of print.
PMID: 41214294DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 6, 2023
First Posted
December 14, 2023
Study Start
May 15, 2024
Primary Completion
June 18, 2024
Study Completion
June 18, 2024
Last Updated
September 19, 2024
Record last verified: 2024-09