Music for Pain in the Waiting Room

March 18, 2025 updated by: Adam Hanley, Florida State University

Examining Brief, Music Interventions for Acute Pain in the X-Ray Waiting Room

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Orthopedic Clinic (TOC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
A 4-minute audio recording providing common pain coping techniques (e.g., ice, rest, medication, surgery).
Experimental: Lyrical music
A 4-minute audio recording of Leonard Cohen's song "Hallelujah" sung by Rufus Wainwright with choral accompaniment.
Behavioral: Lyrical Music
A 4-minute audio recording of Leonard Cohen's song "Hallelujah" sung by Rufus Wainwright with choral accompaniment.
Experimental: Instrumental Music
A 4-minute audio recording of instrumental, theta wave music.
Behavioral: Instrumental Music
A 4-minute audio recording of instrumental, theta wave music.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Unpleasantness Numeric Rating Scale
Time Frame: Immediately before to after 4-minute audio recording
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most unpleasant pain imaginable.
Immediately before to after 4-minute audio recording

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity Numeric Rating Scale
Time Frame: Immediately before to after 4-minute audio recording
Single Likert scale item ranging from 0-10, with 0 indicating no pain and 10 representing the most intense pain imaginable.
Immediately before to after 4-minute audio recording
Change in Anxiety Numeric Rating Scale
Time Frame: Immediately before to after 4-minute audio recording
Single Likert scale item ranging from 0-10, with 0 indicating no anxiety and 10 representing severe anxiety,
Immediately before to after 4-minute audio recording

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Self-Transcendent State
Time Frame: Immediately before to after 4-minute audio recording
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.
Immediately before to after 4-minute audio recording
Experience of Emotional Chills
Time Frame: Immediately after 4-minute audio recording
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.
Immediately after 4-minute audio recording

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Actual)

September 11, 2024

Study Completion (Actual)

September 11, 2024

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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