Recruiting NCT06471075
Brief Mindfulness Intervention for Pain Before an In-clinic Orthopedic Procedure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindful Pain Management, Pain Psychoeducation.
- Who it may be relevant to
- Registry conditions: Pain, Chronic Pain, Acute Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Brief (i.e., <10 Minute) Behavioral Intervention for Pain
Overview
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.
Interventions
- Behavioral Mindful Pain Management
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. - Behavioral Pain Psychoeducation
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.
Primary outcome measures
- Change in Pain Unpleasantness Numeric Rating Scale [Time frame: Immediately before to after 7-minute audio recording]
Secondary outcome measures (3)
- Acute Pain [Time frame: Immediately before to after 7-minute audio recording]
- Anxiety [Time frame: Immediately before to after 7-minute audio recording]
- Treatment Satisfaction [Time frame: At the end of the medical provider visit - approximately 1 hour.]
Eligibility criteria
Inclusion criteria
- Undergoing Kyphoplasty or Radiofrequency Ablation at Tallahassee Orthopedic Center
- Fluency with English
- Being 18 and above
Exclusion criteria
- Unable to consent because of physical or mental incapacity.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Tallahassee Orthopedic Clinic (TOC) — Tallahassee
Identifiers
NCT: NCT06471075 · STUDY00004916