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CompletedNCT06511843Updated Mar 21, 2025

Music for Pain in the Waiting Room

An interventional study of Pain Coping Information and Lyrical Music in Pain, Acute, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

This is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of two, 4-minute, audio-recorded, music interventions (one with lyrics and the other without) for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.

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Conditions studied

  • Pain, Acute

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03

In context

Acute Pain

876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.

This study's enrollment of 225 is above the median of 90 across 732 interventional studies indexed under Acute Pain.

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Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥18
  • Seeking treatment at the Tallahassee Orthopedic Center

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment preventing completion of study procedures.
  • Other unstable illness judged by research staff to interfere with study involvement.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
225 participants (actual)

Study arms

  • Active comparator
    Pain Coping Information

    A 4-minute audio recording about common pain coping techniques (e.g., ice, rest, medication, surgery).

    Behavioral: Pain Coping Information

  • Experimental
    Lyrical music

    A 4-minute audio recording of Leonard Cohen's song "Hallelujah" sung by Rufus Wainwright with choral accompaniment.

    Behavioral: Lyrical Music

  • Experimental
    Instrumental Music

    A 4-minute audio recording of instrumental, theta wave music.

    Behavioral: Instrumental Music

Interventions

  • BehavioralPain Coping Information

    A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).

  • BehavioralLyrical Music

    A 4-minute audio recording of Leonard Cohen's song "Hallelujah" sung by Rufus Wainwright with choral accompaniment.

  • BehavioralInstrumental Music

    A 4-minute audio recording of instrumental, theta wave music.

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What researchers measure

Primary outcomes

  1. Change in Pain Unpleasantness Numeric Rating Scale

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.

    Time frame: Immediately before to after 4-minute audio recording

Secondary outcomes

  1. Change in Pain Intensity Numeric Rating Scale

    Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.

    Time frame: Immediately before to after 4-minute audio recording

  2. Change in Anxiety Numeric Rating Scale

    Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety,

    Time frame: Immediately before to after 4-minute audio recording

Other outcomes

  1. Change in Self-Transcendent State

    Self-transcendent state will be measured by the three-item, state version of the validated Nondual Awareness Dimensional Assessment. These three items will be scored on a Likert scale ranging from 0-10, with higher scores representing greater self-transcendence.

    Time frame: Immediately before to after 4-minute audio recording

  2. Experience of Emotional Chills

    Emotional chills and goosebumps will be measured with two items, each scored on a 0 to 10 Likert type scale. Higher score represent more chills/goosebumps.

    Time frame: Immediately after 4-minute audio recording

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Study locations

1 site
  • Tallahassee Orthopedic Clinic (TOC)
    Tallahassee, Florida 32308, United States
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06511843
Lead sponsor
Florida State University
Responsible party
Adam Hanley (Associate Professor, Florida State University) — Principal investigator
First posted
Jul 22, 2024
Start date
Jul 23, 2024
Primary completion
Sep 11, 2024
Completion
Sep 11, 2024
Last update
Mar 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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