Mindfulness and Music for Acute Pain

Overseen By Adam W Hanley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Physical or mental incapacity

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how various combinations of mindfulness and music can help manage acute pain for patients in an orthopedic clinic. Participants will experience one of four treatments: mindfulness alone, mindfulness with a steady tone, mindfulness with binaural beats (special sounds that can affect brainwaves), or mindfulness with binaural beats and soothing music. It suits those receiving pain care at the Tallahassee Orthopedic Center who can follow English instructions well. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that mindfulness techniques are generally safe for managing pain. Studies have found that mindfulness-based stress reduction (MBSR) can reduce pain and improve mental health without causing serious side effects. When combined with music or specific sounds, such as binaural beats, these techniques have shown promise in reducing stress and pain.

Binaural beats involve listening to two slightly different tones in each ear and have been studied for their calming effects. Research has found that they lower pain and anxiety levels, especially when used with music. The combination of mindfulness and binaural beats is well-tolerated and has not been linked to significant negative effects.

For the treatments in this trial—mindfulness recordings with added sounds like sustained tones, binaural beats, and theta music—existing evidence supports their safety. They are non-invasive and have been shown to be effective in reducing stress and pain in various settings. Overall, these treatments are considered safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for acute pain because they explore non-drug methods that might offer relief without the side effects of traditional pain medications like opioids or NSAIDs. Mindfulness Pain Management focuses on training the mind to manage pain perception, potentially reducing the need for medication. The other treatments incorporate binaural beats and specialized music, which could alter brainwave activity to promote relaxation and pain relief. These approaches are unique because they aim to harness the brain's natural ability to modulate pain, offering a holistic alternative to conventional drugs.

What evidence suggests that this trial's treatments could be effective for acute pain?

Research has shown that listening to mindfulness recordings can help people with chronic pain feel less pain and move better. Mindfulness meditation reduces pain in both lab tests and real-life situations. In this trial, participants will be assigned to different treatment arms to explore various mindfulness approaches. One arm will involve Mindfulness Pain Management, while others will include Mindfulness Recording with Binaural Beats, Mindfulness Recording with Binaural Beats and Theta Music, and Mindfulness Recording With Sustained Tone. Some studies suggest that adding binaural beats—special sound patterns—to mindfulness exercises might help manage stress, but there's not enough proof that they relieve pain. Similarly, music with certain sound patterns might help reduce anxiety, but its effect on pain remains unclear. While some combinations of mindfulness and music have been found to help with anxiety and sleep, more research is needed to understand how they affect sudden pain. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients experiencing acute pain who are currently in an orthopedic clinic waiting room. There aren't specific inclusion or exclusion criteria provided, so it's likely open to those willing to participate.

Inclusion Criteria

Receiving pain treatment at Tallahassee Orthopedic Center

Understanding English instructions fluently

Exclusion Criteria

I am unable to give consent due to physical or mental reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive a 5-minute mindfulness recording intervention with various audio conditions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in anxiety and pain levels immediately after the intervention

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Mindfulness Pain Management
• Mindfulness Recording with Binaural Beats
• Mindfulness Recording with Binaural Beats and Theta Music
• Mindfulness Recording With Sustained Tone

Trial Overview

The study tests the effect of a mindfulness recording combined with music on acute pain. Participants will try one of four different audio interventions involving mindfulness and various sound frequencies or music during their wait.

How Is the Trial Designed?

Group I: Mindfulness Recording with Binaural Beats and Theta Music Experimental Treatment 1 Intervention

Group II: Mindfulness Recording with Binaural Beats Experimental Treatment 1 Intervention

Group III: Mindfulness Recording With Sustained Tone Experimental Treatment 1 Intervention

Group IV: Mindfulness Pain Management Active Control 1 Intervention

Mindfulness Pain Management is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Mindfulness-Based Pain Management for:

• Chronic Pain
• Acute Pain
• Orthopedic Pain

Approved in European Union as Mindfulness-Based Pain Management for:

• Chronic Pain
• Cancer Pain
• Musculoskeletal Pain

Approved in Canada as Mindfulness-Based Pain Management for:

• Chronic Pain
• Acute Pain
• Palliative Care

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

An eight-week Mindfulness-Based Stress Reduction (MBSR) program showed significant improvements in pain disability, psychological distress, and activity levels among 17 adult patients with chronic pain.

Participants reported a greater willingness to experience pain and lower subjective ratings of current pain, indicating that MBSR can be an effective intervention for managing chronic pain symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction: pilot study of a treatment group for patients with chronic pain in a primary care setting. Beaulac, J., Bailly, M.[2019]

The 8-week mindfulness-based stress reduction (MBSR) program showed medium-sized improvements in health-related quality of life, psychological functioning, and pain perception among 22 patients with chronic low back pain, indicating its potential effectiveness as a treatment.

Despite the positive outcomes in psychological and quality of life measures, EEG analyses did not show significant changes in thalamocortical dysrhythmia, suggesting that while MBSR is feasible and beneficial, further research is needed to understand its specific effects on brain activity related to chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based Stress Reduction (MBSR) as Treatment for Chronic Back Pain - an Observational Study with Assessment of Thalamocortical Dysrhythmia. Schmidt, S., Gmeiner, S., Schultz, C., et al.[2015]

A systematic review of 20 studies on brief mindfulness-based interventions (BMBIs) suggests that they may be effective for managing acute pain, especially when delivered by a provider and lasting more than 5 minutes.

However, the overall evidence is limited and inconclusive, indicating that more rigorous and larger-scale studies are necessary before BMBIs can be recommended as a primary treatment for chronic or acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. McClintock, AS., McCarrick, SM., Garland, EL., et al.[2023]

In a feasibility trial involving 60 patients with migraine headaches, Mindfulness-Based Stress Reduction (MBSR) was successfully implemented, with 68% of participants adhering to the intervention by attending at least 5 out of 8 classes.

Key factors for successful recruitment and retention included close monitoring of recruitment activities, flexibility in protocol modifications, and integration within the healthcare delivery system, highlighting the importance of these strategies for future MBSR trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine. Law, H., Avins, A., Stahl, R., et al.[2021]

Mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT) both show clinically significant benefits in improving physical functioning and reducing pain intensity in patients with chronic pain, based on a review of 21 studies involving over 1,900 participants.

There was no significant difference in effectiveness between MBSR and CBT, suggesting that both therapies are viable options for managing chronic pain, but further research is needed to standardize measures and guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative evaluation of group-based mindfulness-based stress reduction and cognitive behavioural therapy for the treatment and management of chronic pain: A systematic review and network meta-analysis. Khoo, EL., Small, R., Cheng, W., et al.[2023]

In a study of 28 patients with chronic pain, an 8-week mindfulness-based pain management program (MBPM) improved mental health and perceived control over pain, but did not significantly reduce clinical or experimental pain ratings.

The improvements in mental health were linked to increased brain activity in areas responsible for cognitive control and emotional regulation during pain anticipation, suggesting that better emotional regulation may enhance the perception of control over pain rather than directly reducing pain intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychobiological correlates of improved mental health in patients with musculoskeletal pain after a mindfulness-based pain management program. Brown, CA., Jones, AK.[2022]

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