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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18
Be older than 18 years old
Must not have
Cognitive impairment preventing completion of study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after 4-minute audio recording
Awards & highlights
No Placebo-Only Group
Summary
This trial will look at the effects of listening to different types of music for 4 minutes on orthopedic patients' pain compared to listening to a recording about pain education for the same amount of time
Who is the study for?
This trial is for orthopedic patients experiencing acute pain while in the waiting room. Participants should be willing to listen to audio recordings and not have any conditions that would interfere with their ability to understand or hear the content.
What is being tested?
The study is testing how listening to two types of music (one instrumental and one with lyrics) for four minutes each affects pain, compared to a four-minute educational recording about coping with pain.
What are the potential side effects?
There are no significant side effects expected from participating in this trial as it involves non-invasive interventions like listening to music or an educational recording.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have cognitive issues that prevent me from following study procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately after 4-minute audio recording
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after 4-minute audio recording
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
Other study objectives
Change in Self-Transcendent State
Experience of Emotional Chills
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Lyrical musicExperimental Treatment1 Intervention
A 4-minute audio recording of Leonard Cohen's song "Hallelujah" sung by Rufus Wainwright with choral accompaniment.
Group II: Instrumental MusicExperimental Treatment1 Intervention
A 4-minute audio recording of instrumental, theta wave music.
Group III: Pain Coping InformationActive Control1 Intervention
A 4-minute audio recording about common pain coping techniques (e.g., ice, rest, medication, surgery).
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Who is running the clinical trial?
Florida State UniversityLead Sponsor
219 Previous Clinical Trials
36,165 Total Patients Enrolled
2 Trials studying Acute Pain
280 Patients Enrolled for Acute Pain
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