Brief Mindfulness Intervention for Pain Before an In-clinic Orthopedic Procedure
Brief (i.e., <10 Minute) Behavioral Intervention for Pain
1 other identifier
interventional
80
1 country
1
Brief Summary
This project is a single-site, randomized controlled trial designed to investigate the impact of a 7-minute mindfulness intervention on pain among patients undergoing kyphoplasty or radiofrequency ablation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Aug 2024
Typical duration 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
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2024
CompletedFirst Posted
Study publicly available on registry
June 24, 2024
CompletedStudy Start
First participant enrolled
August 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 11, 2026
September 4, 2025
September 1, 2025
2.1 years
June 13, 2024
September 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Pain Unpleasantness Numeric Rating Scale
Change in acute pain unpleasantness will be measured with an individual item ("How unpleasant is your pain, right now?") rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain unpleasantness.
Immediately before to after 7-minute audio recording
Secondary Outcomes (3)
Acute Pain
Immediately before to after 7-minute audio recording
Anxiety
Immediately before to after 7-minute audio recording
Treatment Satisfaction
At the end of the medical provider visit - approximately 1 hour.
Study Arms (2)
Mindfulness Pain Management
EXPERIMENTALPain Psychoeducation
ACTIVE COMPARATORInterventions
The mindfulness intervention will involve a 2-minute introduction to mindfulness as a technique for pain management followed by a 5-minute, audio-guided, mindful breathing practice.
In the pain psychoeducation intervention, participants will be provided timematched information about different pain management strategies (e.g., ice, rest) and accessible resources to promote overall well-being.
Eligibility Criteria
You may qualify if:
- Undergoing Kyphoplasty or Radiofrequency Ablation at Tallahassee Orthopedic Center
- Fluency with English
- Being 18 and above
You may not qualify if:
- Unable to consent because of physical or mental incapacity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tallahassee Orthopedic Clinic (TOC)
Tallahassee, Florida, 32308, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 13, 2024
First Posted
June 24, 2024
Study Start
August 22, 2024
Primary Completion (Estimated)
September 11, 2026
Study Completion (Estimated)
September 11, 2026
Last Updated
September 4, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share