- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07391891
Musical Mindfulness for Pain in the ED Waiting Room
Use of Music Mindfulness for Pain Management in the ED Waiting Room
Studies have shown that 60-70% of patients in the Emergency Department (ED) experience pain. With pain being such a broad issue in the ED, the ED is expected to deliver safe and effective treatment of pain. However, with the current ongoing opioid epidemic, it is important to consider other methods, both pharmacologic and nonpharmacologic, of pain reduction. Jazz music specifically has been demonstrated to have therapeutic effects on pain that can be used to lower the quantity of opioids administered to patients.
Non-pharmacological interventions in the emergency department for pain typically consist of splinting an injury, applying heat or cold, or various distractions following initial and sequential pain assessment. Pharmacological interventions for pain in the Emergency Department involve the administration of acetaminophen, muscle relaxers, topical anesthetics, opioids, to name a few.
In the emergency department (ED), providers are increasingly hesitant to prescribe opioids over the past decade due to the current opioid epidemic, in which there is an increasing proportion of people that develop an addiction to opioids, including those that are prescribed to them for pain management.. While emergency medicine providers' decrease in opioid prescriptions pertains to their implementation of opioid-prescribing policies, little evidence has been found demonstrating a direct link in these policies to decreases in substance misuse. Consequently, providers find themselves needing to become ingenious in their approach to pain in patients through the integration of pharmacologic and non-pharmacologic mediums of analgesia.
A recent randomized controlled trial (RCT) from Brigham and Women's Hospital in Boston sought to identify the qualitative responses from patients in the ED following the arbitrary distribution of either supervised or unsupervised music therapy over a time period of 4 hours. The initial results found that, generally speaking, music therapy may lower reported pain and anxiety scores. Furthermore, stronger results were identified in case subjects with higher initial reports of pain via a pain catastrophizing scale, implying that a higher baseline of pain results in more relief from music therapy. One shortcoming in the article is the lack of analysis with reported results and the biopsychosocial model of pain. Heavy emphasis is placed on the psychological and social components of pain in the Brigham and Women's article through the implementation of the Pain Catastrophizing Scale and Brief Pain Inventory scoring done during the RCT, but no focus on linked biological changes in the subjects through the music therapy intervention.
The purpose of this study is to (i.) assess the effect of a video training about musical pain management followed by a 15-minute music listening intervention on self-reported pain scores in ED patients with neck and back pain. The investigators also aim to (ii.) evaluate patient satisfaction and emotional response following the intervention. Opioid medications are commonly used to reduce substantial pain, and music therapy has been found to reduce associated pain and anxiety in patients, then the use of music therapy could be an aid in medicine to reduce opioid intake. The investigators hypothesize that the usage of a training on musical pain management combined with a specified jazz musical intervention will produce a significantly lower measured pain score in comparison to a video on mindful pain management followed by the patient's choice of activities.
Study Overview
Status
Intervention / Treatment
Detailed Description
- Patients presenting to the Emergency Department with neck or back pain in the waiting room are approached for the study.
- Researchers confirm patients' interest. Consent patient by having them sign the HIPAA Waiver and Informed Consent Form.
- Obtain an initial pain measurement of the subject prior to randomization. Additionally, obtain demographic information about the subject
- Randomize subjects into either the intervention group (mindful music listening video followed by jazz music playlist administration) or the control group (pain management video followed by video or music of participants choice administered) using a simple randomizer, such as the Sealed Envelope application.
- Deliver musical pain management video (intervention group) OR allow for the current standard of care with pain management presentation video for 15 minutes (control group).
- Deliver musical intervention to subjects in the intervention group for 15 minutes, or allow subjects in the control group to listen to music or video of their choice for 15 minutes.
- Following the 15-minute music intervention or 15-minute control, obtain a new pain measurement
- Follow up after 30 minutes after the music intervention finished and acquire pain measurements again
- Follow up 1 hour after the music intervention finished and acquire pain measurements again
- Administer brief survey to patient asking if they enjoyed or disliked the experience of the study and if they are likely or unlikely to participate again.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sean Young, PhD
- Phone Number: 6502455490
- Email: syoung5@hs.uci.edu
Study Contact Backup
- Name: Danielle Matonis, MD
- Email: dmatonis@hs.uci.edu
Study Locations
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California
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Orange, California, United States, 92868
- University of California, Irvine, Emergency Department
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Contact:
- Phone Number of ED
- Phone Number: 714-456-8008
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - Age >= 18 years old and <=75 years old
- Patient presents with neck or back pain
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindful Music Training + Music Intervention
Participants will be given a video training on listening to music mindfully to reduce pain.
Following this, patients will be given a 15-minute jazz music playlist to listen to.
|
Participant's will be taught how to mindfully listen to jazz to reduce pain
|
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Active Comparator: Standard of Care Pain Management Training + Participant's Choice of Intervention
Participants will be given a video demonstrating how to mindfully manage pain, following this will be a 15-minute period of the participant's choice of activity
|
Participant's will be taught how to mindfully listen to jazz to reduce pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score using Pain, Enjoyment of Life and General Activity Scale (PEG)
Time Frame: Day 1
|
Pain score will be obtained using PEG scale Title of first scale: Pain Pain will be rated on a scale of 0-10 , with 0 being no pain, and 10 being pain as bad as you can imagine (pain increases as scale increases) Title of second scale: Interference Interference will be rated on a scale of 0-10, with 0 being no interference, and 10 being completely interferes (interference increases as scale increases) Higher score is a worse outcome |
Day 1
|
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Pain Intensity
Time Frame: Day 1
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Pain will be scored using pain intensity scale Title of scale: Frequency 0-3, with 0 being not at all and 3 being nearly every day Higher score is a worse outcome
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with Study
Time Frame: 1 hour and 30 minutes after baseline
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Participants will be asked their satisfaction of the study to gauge if music therapy or mindful pain management is a feasible process in the Emergency Department Waiting Room How positive was your experience from 1-5, which 1 being horrible and 5 being amazing? How likely would you be to recommend this study to others undergoing similar pain, with 1 being not likely at all and 5 being extremely likely ? How easy was it to participate in this study from 1-5, with 1 being not easy at all, and 5 being extremely easy ? Would you consider undergoing this procedure again in the future? Yes or no, and why? |
1 hour and 30 minutes after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sean Young, PhD, University of California, Irvine. Department of Emergency Medicine
- Study Chair: Ryan Rokerya, Expected BS Dec 2026, University of California, Irvine. Department of Emergency Medicine
- Study Chair: Tyler Mitchell, Expected BS Jun 2026, University of California, Irvine. Department of Emergency Medicine
- Study Chair: Dominic A Ugarte, M.D., University of California, Irvine. Department of Emergency Medicine
Publications and helpful links
General Publications
- Chai PR, Schwartz E, Hasdianda MA, Azizoddin DR, Kikut A, Jambaulikar GD, Edwards RR, Boyer EW, Schreiber KL. A Brief Music App to Address Pain in the Emergency Department: Prospective Study. J Med Internet Res. 2020 May 20;22(5):e18537. doi: 10.2196/18537.
- Pourmand A, Jasani G, Shay C, Mazer-Amirshahi M. The Evolving Landscape of Acute Pain Management in the Era of the Opioid Crisis. Curr Pain Headache Rep. 2018 Aug 27;22(11):73. doi: 10.1007/s11916-018-0728-y.
- Young SD, Kim J, Hanley A. Mindful Jazz and Preferred Music Interventions Reduce Pain Among Patients With Chronic Pain and Anxiety: A Pilot Randomized Controlled Trial. Cureus. 2025 Mar 12;17(3):e80485. doi: 10.7759/cureus.80485. eCollection 2025 Mar.
- Chanana L, Jegaraj MA, Kalyaniwala K, Yadav B, Abilash K. Clinical profile of non-traumatic acute abdominal pain presenting to an adult emergency department. J Family Med Prim Care. 2015 Jul-Sep;4(3):422-5. doi: 10.4103/2249-4863.161344.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Pathologic Processes
- Disease Attributes
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Back Pain
- Pain
- Emergencies
- Musculoskeletal Pain
- Agnosia
- Neck Pain
Other Study ID Numbers
- STUDY00000311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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