Pain, Chronic Pain, Acute Pain
Conditions
Keywords
mindfulness, kyphoplasty, radiofrequency ablation
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.
Interventions
BEHAVIORALMindful 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.
BEHAVIORALPain 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.
Sponsors
Florida State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Unpleasantness Numeric Rating Scale | Immediately before to after 7-minute audio recording | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction | At the end of the medical provider visit - approximately 1 hour. | Treatment satisfaction at the visit's end will be measured with three, validated items (1. How satisfied are you with your medical care today?, 2. Was the visit/procedure tolerable?, 3. Would you have the same procedure again?), each scored on an 11-point, Likert-type scale ranging from 0 to 10. Higher scores represent greater treatment satisfaction |
| Acute Pain | Immediately before to after 7-minute audio recording | Change in acute pain intensity will be measured with an individual item (How much pain do you have, right now?) rated on a numeric rating scale. Scores range from 0 to 10, with higher scores reflecting greater acute pain intensity. |
| Anxiety | Immediately before to after 7-minute audio recording | Change in anxiety from baseline will be assessed with the Generalized Anxiety Disorder 2-item. Scores range from 0 to 6, with higher scores reflecting greater anxiety. |
Countries
United States
Contacts
Primary ContactAdam W Hanley, Ph.D.
Backup ContactAllison R Davis, M.S.
Outcome results
None listed