NCT06511843

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 23, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2024

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

July 16, 2024

Last Update Submit

March 18, 2025

Conditions

Outcome Measures

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.

    Immediately before to after 4-minute audio recording

Secondary Outcomes (2)

  • Change in Pain Intensity Numeric Rating Scale

    Immediately before to after 4-minute audio recording

  • Change in Anxiety Numeric Rating Scale

    Immediately before to after 4-minute audio recording

Other Outcomes (2)

  • Change in Self-Transcendent State

    Immediately before to after 4-minute audio recording

  • Experience of Emotional Chills

    Immediately after 4-minute audio recording

Study Arms (3)

Pain Coping Information

ACTIVE COMPARATOR

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

Behavioral: Pain Coping Information

Lyrical music

EXPERIMENTAL

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

Behavioral: Lyrical Music

Instrumental Music

EXPERIMENTAL

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

Behavioral: Instrumental Music

Interventions

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

Pain Coping Information
Lyrical MusicBEHAVIORAL

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

Lyrical music

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

Instrumental Music

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tallahassee Orthopedic Clinic (TOC)

Tallahassee, Florida, 32308, United States

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 22, 2024

Study Start

July 23, 2024

Primary Completion

September 11, 2024

Study Completion

September 11, 2024

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations