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Behavioral Intervention

Mindfulness and Music for Acute Pain

N/A
Recruiting
Research Sponsored by Florida State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Unable to consent because of physical or mental incapacity.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately before and after 5-minute audio recording
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how listening to a combination of mindfulness exercises and music can help reduce acute pain in patients at an orthopedic clinic. Participants will be randomly assigned to one of four groups, each

Who is the study for?
This trial is for patients experiencing acute pain who are currently in an orthopedic clinic waiting room. There aren't specific inclusion or exclusion criteria provided, so it's likely open to those willing to participate.
What is being tested?
The study tests the effect of a mindfulness recording combined with music on acute pain. Participants will try one of four different audio interventions involving mindfulness and various sound frequencies or music during their wait.
What are the potential side effects?
Since this trial involves listening to recordings, side effects might be minimal but could include discomfort from wearing headphones, slight ear fatigue, or dissatisfaction with the audio content.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to give consent due to physical or mental reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately before and after 5-minute audio recording
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before and after 5-minute audio recording for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pain Unpleasantness Numeric Rating Scale
Secondary study objectives
Change in Anxiety Numeric Rating Scale
Change in Pain Intensity Numeric Rating Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Recording with Binaural Beats and Theta MusicExperimental Treatment1 Intervention
Group II: Mindfulness Recording with Binaural BeatsExperimental Treatment1 Intervention
Group III: Mindfulness Recording With Sustained ToneExperimental Treatment1 Intervention
Group IV: Mindfulness Pain ManagementActive Control1 Intervention

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Who is running the clinical trial?

Florida State UniversityLead Sponsor
224 Previous Clinical Trials
36,535 Total Patients Enrolled
8 Trials studying Pain
755 Patients Enrolled for Pain
~133 spots leftby May 2025
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