Nonpharmacologic Treatment for Surgery

(VERITAS Trial)

Overseen By Karthik Raghunathan, MD MPH

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Durham VA Medical Center

Disqualifiers: Hearing loss, Risk of bleeding, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

400 Participants Needed

Trial Summary

What is the purpose of this trial?

The study aims to assess the implementation and effectiveness of Integrative Treatments - Music Medicine, Aromatherapy, and Battlefield Acupuncture - in the management of perioperative pain and anxiety, and in the reduction of related pharmacologic treatments.

Do I need to stop taking my current medications for this trial?

The trial does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Music Medicine, Aromatherapy, Battlefield Acupuncture for surgery?

Research shows that music therapy can significantly reduce pain and anxiety after surgery, as well as help with relaxation and stress. Additionally, acupuncture has been found to decrease pain and improve mood in postoperative cancer patients. ^{1 2 3 4 5}

Is nonpharmacologic treatment like music therapy, aromatherapy, and acupuncture safe for humans?

Research shows that nonpharmacologic treatments like music therapy, aromatherapy, and acupuncture are generally safe for humans. These treatments are low-risk and have been used to help manage pain and anxiety in various medical settings, including surgery and cancer care. ^{1 6 7 8 9}

How does the treatment of Music Medicine, Aromatherapy, and Battlefield Acupuncture differ from other treatments for surgery?

This treatment is unique because it uses non-drug methods like music, aromatherapy, and acupuncture to reduce anxiety and pain during surgery, potentially decreasing the need for medications that can have side effects. Music Medicine, in particular, works by calming the autonomic nervous system, which helps manage stress and pain without the use of drugs. ^{8 10 11 12 13}

Eligibility Criteria

This trial is for veterans scheduled for surgery at the Durham VA who do not have hearing loss, ear procedures, a risk of bleeding, or anosmia (loss of smell). It's designed to help those dealing with joint pain from injuries and issues related to anesthesia and knee osteoarthritis.

Inclusion Criteria

Veterans scheduled to undergo procedures at the Durham VA

Exclusion Criteria

History of hearing loss

I have had procedures done on my ear.

I cannot smell anything.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Assessment

Assessment of heart rate variability and implementation measures among patients and providers

5 days

Daily assessments

Treatment

Participants receive integrative treatments such as Music Medicine, Aromatherapy, and Battlefield Acupuncture, or standard care

5 days

Daily treatments and assessments

Follow-up

Participants are monitored for pain, opioid use, and quality of recovery

5 days

Daily assessments

Treatment Details

Interventions

• Music Medicine, Aromatherapy, Battlefield Acupuncture

Trial Overview The study tests non-drug treatments like Music Medicine, Aromatherapy, and Battlefield Acupuncture against standard care. The goal is to see if these can better manage pain and anxiety around the time of surgery while reducing the need for medications.

Participant Groups

Group I: Integrative Treatment Active Control 1 Intervention

200 participants will receive at least one of three integrative treatments: Music Medicine, Aromatherapy, Battlefield Acupuncture

Group II: Standard Care Active Control 1 Intervention

200 patients will not receive standard care without any additional integrative treatments

Who Is Running the Clinical Trial?

Durham VA Medical Center

Lead Sponsor

Trials

40

Recruited

9,300+

Findings from Research

Perioperative music therapy significantly reduces postoperative pain and anxiety, with a large effect size observed in a meta-analysis of 19 randomized controlled trials involving 1803 patients.

The therapy also helps stabilize vital signs, leading to lower blood pressure and heart rate on the first postoperative day, although it does not improve hospital satisfaction or reduce nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. Li, G., Yu, L., Yang, Y., et al.[2023]

Music therapy is an effective complementary treatment for cancer patients, helping to improve mood, reduce stress, pain, and anxiety, and enhance relaxation during their treatment process.

Integrating music therapy into supportive cancer care can significantly promote overall wellness and improve both physical and emotional well-being, contributing to a better quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. Stanczyk, MM.[2022]

Music therapy, which has been used since ancient times and incorporated into modern medicine since the 1950s, is now a common practice in cancer care, particularly in large cancer centers in the U.S.

When combined with conventional cancer treatments, music therapy has been shown to improve patients' quality of life, enhance emotional expression, reduce stress, and alleviate physical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in a comprehensive cancer center. Richardson, MM., Babiak-Vazquez, AE., Frenkel, MA.[2008]

References

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

Symptom management with massage and acupuncture in postoperative cancer patients: a randomized controlled trial. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of live music therapy sessions on quality of life indicators, medications administered and hospital length of stay for patients undergoing elective surgical procedures for brain. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

The effect of music on simulated surgical performance: a systematic review. [2020]

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

Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. [2023]

5. Scotland pubmed.ncbi.nlm.nih.gov

Effects of music therapy on pain, anxiety, and vital signs in patients after thoracic surgery. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Effects of aroma therapy and music intervention on pain and anxious for breast cancer patients in the perioperative period]. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Music Therapy as a Form of Nonpharmacologic Pain Modulation in Patients with Cancer: A Systematic Review of the Current Literature. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Music versus midazolam during preoperative nerve block placements: a prospective randomized controlled study. [2022]

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

Aromatherapy Plus Music Therapy Improve Pain Intensity and Anxiety Scores in Patients With Breast Cancer During Perioperative Periods: A Randomized Controlled Trial. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Review of Perioperative Music Medicine: Mechanisms of Pain and Stress Reduction Around Surgery. [2023]

11. Poland pubmed.ncbi.nlm.nih.gov

Music therapy in supportive cancer care. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Music therapy in a comprehensive cancer center. [2008]

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

Emotional foundations of music as a non-pharmacological pain management tool in modern medicine. [2022]