Health TrialsbyHealthPanel

Brief Mindfulness Intervention for Pain Before an In-clinic Orthopedic Procedure

ConditionsPainChronic PainAcute Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFlorida State University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Undergoing Kyphoplasty or Radiofrequency Ablation at Tallahassee Orthopedic Center

Fluency with English

Being 18 and above

Disqualifiers

Unable to consent because of physical or mental incapacity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindful Pain Management

    Behavioral

    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.

  • Pain Psychoeducation

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Mindfulness Pain ManagementExperimental treatment 1 intervention
Group B: Pain PsychoeducationActive comparator 1 intervention

Trial outcomes

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.

Time frame
Immediately before to after 7-minute audio recording

Secondary outcomes

1

Acute Pain

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.

Time frame
Immediately before to after 7-minute audio recording
2

Anxiety

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.

Time frame
Immediately before to after 7-minute audio recording
3

Treatment Satisfaction

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

Time frame
At the end of the medical provider visit - approximately 1 hour.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Florida State University

Lead sponsor

Source ClinicalTrials.gov
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