Music Therapy for Pre-operative Stress and Pain

Overseen By Mei Rui, DMA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Deaf, Under 18, Non-English, others

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

Compensation: Varies

Number of Visits: 1

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how music therapy might reduce stress and pain before surgery. It compares three groups: one with no music, one with live music, and one with recorded music using the Steinway Spirio M recording/player piano. The study measures changes in vital signs, mood, and pain levels through simple questionnaires. It suits individuals about to undergo neurosurgery who are comfortable listening to music. Participants must speak English fluently and have normal hearing. As an unphased trial, this study provides a unique opportunity to contribute to understanding the potential benefits of music therapy in surgical settings.

Will I have to stop taking my current medications?

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

What prior data suggests that this music therapy is safe for pre-operative patients?

Research shows that music therapy is generally safe and easy to manage. Studies have found that listening to music, whether live or recorded, is a low-risk treatment. It can help reduce stress and pain without causing harmful side effects. One review highlighted that listening to pre-recorded music is both effective and safe. No evidence of major negative effects from these music therapy methods exists. Participants in past studies handled the treatments well, suggesting it is a safe option for reducing stress and pain before surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using music therapy for pre-operative stress and pain because it offers a unique, non-invasive approach compared to standard treatments like medication and cognitive-behavioral therapy. Unlike typical methods that often involve drugs or psychological interventions, this trial explores the calming effects of a Steinway Spirio M piano, either played live or recorded, which could provide a soothing experience without side effects. Additionally, music therapy has the potential to enhance patient comfort and reduce anxiety in a natural and enjoyable way, making it an appealing alternative or complement to existing pre-operative care options.

What evidence suggests that music therapy could be effective for pre-operative stress and pain?

Research shows that music therapy can help reduce anxiety and pain for patients about to undergo surgery. A review of several studies found that listening to music significantly lowered anxiety and pain compared to not listening to music. Another study found that patients who listened to music before and after surgery needed less pain medication. In this trial, researchers will randomize participants into different groups: one group will experience simulated live music, another will listen to recorded music, and a control group will not listen to music. Both live and recorded music have been shown to reduce stress and improve mood. These findings suggest that music can be a simple yet powerful way to manage stress and discomfort before surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

Mei Rui, DMA

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for neurosurgical patients who are experiencing stress and pain before surgery. It aims to include a diverse group of 132 patients and 30 providers. Participants must meet certain health criteria, but specific inclusion and exclusion details aren't provided.

Inclusion Criteria

If none of the patient's providers is willing to provide informed consent for the study, the patient may still be enrolled

I am having an awake craniotomy to remove a brain tumor.

Providers will only be included and paired with patients who have consented

Exclusion Criteria

I am deaf or have a hearing disability.

I am under 18 years old.

Patient was previously enrolled in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Intervention

Participants receive live or recorded music-based interventions to assess impact on stress, mood, pain, and biomarkers

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in stress biomarkers and mood post-intervention

Through study completion

What Are the Treatments Tested in This Trial?

Interventions

• Steinway Spirio M recording/player piano

Trial Overview

The Music-STAR Trial is testing the effects of live and recorded music from a Steinway Spirio M piano on pre-operative stress, mood, pain levels, vital signs, and various biomarkers in blood samples like hormones and immune indicators.

How Is the Trial Designed?

Group I: Patients: Simulated Live Music Experimental Treatment 1 Intervention

Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

Group II: Patients: Recorded Music Experimental Treatment 1 Intervention

Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

Group III: Patients: Control: No Music Experimental Treatment 1 Intervention

Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

Music can be an effective therapeutic intervention for managing anxiety and pain during procedural or operative interventions, as supported by a systematic review conducted by The Joanna Briggs Institute.

The Best Practice Information Sheet recommends using music before, during, and after procedures to enhance patient comfort, highlighting its potential benefits in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Joanna Briggs Institute Best Practice Information Sheet: music as an intervention in hospitals. [2022]

Music has the potential to decrease pain perception during minor surgical procedures, suggesting a non-pharmacological approach to pain management.

The study indicates that incorporating music into surgical settings could enhance patient comfort and reduce reliance on pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music proves therapeutic to pain levels. [2019]

In a study of 60 patients recovering from spine surgery, those who received music therapy in addition to standard care experienced a significant reduction in pain levels, with visual analog scale (VAS) scores decreasing from 6.20 to 5.09, compared to a slight increase in the control group.

While music therapy effectively reduced pain, it did not significantly impact anxiety or depression levels compared to standard care alone, suggesting its primary benefit lies in pain management rather than emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music Therapy Increases Comfort and Reduces Pain in Patients Recovering From Spine Surgery. Mondanaro, JF., Homel, P., Lonner, B., et al.[2017]

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 significantly reduces anxiety levels in patients undergoing plastic surgery, with a standardized mean difference of -3.64, indicating a strong effect compared to no music intervention.

While music did not show a statistically significant effect on pain reduction (mean difference of -12.06), it remains a safe and cost-effective option for enhancing patient comfort during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Music in a Plastic Surgery Setting: A Systematic Review and Meta-analysis. Zapata-Copete, JA., Cordoba-Wagner, MJ., García-Perdomo, HA.[2023]

Music therapy, provided for 30 minutes daily over 6 months, significantly reduced emotional pain scores in patients after mechanical valve replacement compared to a control group that received standard treatment.

Patients who received music therapy also reported a higher emotional function score in their quality of life assessments, indicating an overall improvement in their well-being post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Music Therapy on the Chronic Pain and Midterm Quality of Life of Patients after Mechanical Valve Replacement. Lin, ZW., Huang, ST., Xu, N., et al.[2020]

In a study of 168 patients undergoing elective abdominal surgery, music significantly reduced pain intensity and distress on the second postoperative day compared to a control group.

While music intervention was effective in the short term, its long-term effects on pain were not significant by the third postoperative day, suggesting it is best used as a temporary adjunct to pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of listening to music on pain intensity and pain distress after surgery: an intervention. Vaajoki, A., Pietilä, AM., Kankkunen, P., et al.[2022]

A systematic review of 42 randomized controlled trials found that music interventions can significantly reduce anxiety and pain in perioperative patients, with positive effects observed in about half of the studies.

Given the low cost and potential benefits of music therapy, further research is encouraged to better understand its mechanisms and enhance patient care in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The anxiety- and pain-reducing effects of music interventions: a systematic review. Nilsson, U.[2022]

A systematic review of 92 randomized controlled trials involving 7385 patients found that music interventions significantly reduced anxiety by an average of 21 mm and pain by 10 mm on a 100-mm visual analogue scale during invasive surgeries.

The study demonstrated that music interventions during general anesthesia led to a notable decrease in pain compared to control conditions, highlighting music as an effective non-pharmacological approach to enhance patient comfort in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis evaluating music interventions for anxiety and pain in surgery. Kühlmann, AYR., de Rooij, A., Kroese, LF., et al.[2019]

In a study of 60 patients undergoing spinal surgery, those who listened to music experienced significantly lower levels of anxiety (VAS scores of 0.8-2.0) and pain (VAS scores of 1.7-3.0) compared to the control group, which reported higher scores for both anxiety (2.1-5.1) and pain (4.4-6.0).

Music therapy also resulted in lower blood pressure one hour after surgery in the study group compared to the control group, indicating a physiological benefit, although no significant differences were found in stress hormone levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy for patients receiving spine surgery. Lin, PC., Lin, ML., Huang, LC., et al.[2014]

In a study of 60 cancer patients undergoing painful medical procedures, music intervention did not provide better pain and anxiety relief compared to simple distraction or standard treatment, indicating that these methods may be equally effective.

Patients expressed individual preferences regarding distraction during procedures, suggesting that healthcare providers should assess and accommodate these preferences to enhance patient comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music versus distraction for procedural pain and anxiety in patients with cancer. Kwekkeboom, KL.[2018]

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Music Therapy for Pre-operative Stress and Pain

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