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

200 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Mindfulness and Music for Acute Pain?

Research shows that mindfulness-based stress reduction (MBSR) can help reduce pain intensity and improve physical functioning in people with chronic pain. Additionally, brief mindfulness-based interventions have been found effective for managing both acute and chronic pain, suggesting potential benefits for acute pain management. ^{1 2 3 4 5}

Is mindfulness and music therapy safe for humans?

Mindfulness-based interventions, like Mindfulness-Based Stress Reduction (MBSR), are generally considered safe for managing pain, as they are non-drug approaches and have been used in various studies without significant safety concerns. ^{1 2 3 4 6}

How does the Mindfulness and Music treatment for acute pain differ from other treatments?

This treatment is unique because it combines mindfulness techniques with music, including binaural beats and theta music, to manage acute pain. Unlike traditional pain treatments that often rely on medication, this approach uses non-drug methods to potentially improve mental health and pain perception by enhancing cognitive control and emotional regulation. ^{1 2 4 5 6}

What is the purpose of this trial?

This project is a single-site, four-arm, randomized controlled trial evaluating a combination mindfulness + music intervention on acute pain among patients in an orthopedic clinic waiting room. Participants will be randomized to one of four conditions: 1) a 5-minute mindfulness recording, 2) a 5-minute mindfulness recording with an accompanying sustained tone at 65.41 Hertz, 3) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear, or 4) a 5-minute mindfulness recording with an accompanying binaural beat set at 65.41 Hertz in the left ear and 69.41 Hertz in the right ear as well as instrumental, theta wave music.

Eligibility Criteria

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

Understanding English instructions fluently

Receiving pain treatment at Tallahassee Orthopedic Center

Exclusion Criteria

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. England 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. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness-based Stress Reduction (MBSR) as Treatment for Chronic Back Pain - an Observational Study with Assessment of Thalamocortical Dysrhythmia. [2015]

3. England 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Brief Mindfulness-Based Interventions for Acute and Chronic Pain: A Systematic Review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Scotland pubmed.ncbi.nlm.nih.gov

Recruitment, retention, and adherence in a randomized feasibility trial of mindfulness-based stress reduction for patients with migraine. [2021]