Does Psychoeducation Improve the Pain Relief Derived From a Brief Intervention
1 other identifier
interventional
646
1 country
1
Brief Summary
This project is a single-site, five-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room psychoeducation about mindfulness impacts the degree of pain relief they experience during a mindfulness-based intervention.
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 Apr 2025
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
Study Start
First participant enrolled
April 10, 2025
CompletedFirst Submitted
Initial submission to the registry
April 23, 2025
CompletedFirst Posted
Study publicly available on registry
April 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 18, 2025
CompletedFebruary 27, 2026
August 1, 2025
8 months
April 23, 2025
February 25, 2026
Conditions
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 3-minute audio recording
Secondary Outcomes (2)
Change in Pain Intensity Numeric Rating Scale
Immediately before to after 3-minute audio recording
Change in Anxiety Numeric Rating Scale
Immediately before to after 3-minute audio recording
Study Arms (5)
Pain Psychoeducation
ACTIVE COMPARATORIn the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.
Mindfulness without Psychoeducation
EXPERIMENTALIn the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.
1 Minute Psychoeducation with 2 Minutes of Mindfulness (Pain Focus)
EXPERIMENTALIn the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.
1 Minute Psychoeducation with 2 Minutes of Mindfulness (Meaning Focus)
EXPERIMENTALIn the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.
2 Minutes of Psychoeducation with 1 Minute of Mindfulness
EXPERIMENTALIn the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.
Interventions
In the pain psychoeducation intervention, participants will be randomized to listen to a three-minute recording about different pain management strategies (e.g., ice, rest) to promote overall well-being.
In the mindfulness without psychoeducation intervention, participants will be randomized to listen to a three-minute mindfulness practice consisting of 1 minute of mindful breathing, 1 minute of mindful mapping, and 1 minute of mindfulness of personal meaning.
In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Pain Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindful mapping.
In the 1 Minute Psychoeducation with 2 minutes of Mindfulness (Meaning Focus) intervention, participants will be randomized to listen to a 1 minute of psychoeducation about mindfulness, 1 minute of mindful breathing and 1 minute of mindfulness of personal meaning.
In the 2 Minutes of Psychoeducation with 1 Minute of Mindfulness intervention, participants will be randomized to listen to a 2 minute of psychoeducation about mindfulness and 1 minute of mindful breathing.
Eligibility Criteria
You may qualify if:
- Receiving pain treatment at Tallahassee Orthopedic Center
- Understanding English instructions fluently
- Being 18 years of age or older
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 23, 2025
First Posted
April 30, 2025
Study Start
April 10, 2025
Primary Completion
December 18, 2025
Study Completion
December 18, 2025
Last Updated
February 27, 2026
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share