Mindfulness and Music for Acute Pain

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Florida State University

Disqualifiers: Physical or mental incapacity

No Placebo Group

Trial Summary

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.

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}

Research Team

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

I am 18 years old or older.

Exclusion Criteria

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

Trial 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 (Behavioral Intervention)
• Mindfulness Recording with Binaural Beats (Behavioral Intervention)
• Mindfulness Recording with Binaural Beats and Theta Music (Behavioral Intervention)
• Mindfulness Recording With Sustained Tone (Behavioral Intervention)

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, Australia 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

🇦🇺 Approved in Australia as Mindfulness-Based Pain Management for:

• Chronic Pain
• Musculoskeletal Pain
• Neuropathic Pain

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Tallahassee Orthopedic Clinic (TOC) Tallahassee, FL

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Patients Recruited

41,100+

Findings from Research

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]

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]

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]

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]