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

Trial Summary

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 data supports the effectiveness of the treatment Steinway Spirio M recording/player piano for reducing pre-operative stress and pain?

Research shows that music therapy can help reduce anxiety and pain in patients undergoing surgery. Studies found that listening to music before and after surgery can lower pain levels and anxiety, making it a promising low-cost option for managing pre-operative stress. ^{1 2 3 4 5}

Is music therapy safe for reducing pre-operative stress and pain?

Research shows that music therapy is a safe way to help reduce anxiety in patients undergoing surgery, with no harmful effects reported in the studies reviewed. ^{1 4 6 7 8}

How does the treatment of music therapy using a Steinway Spirio M piano differ from other treatments for pre-operative stress and pain?

This treatment is unique because it uses a high-quality player piano to deliver music therapy, which can help reduce stress and pain before surgery. Unlike standard treatments that may rely on medication, this approach uses music to create a calming environment, potentially offering a non-invasive and enjoyable way to manage pre-operative anxiety and discomfort. ^{1 7 9 10 11}

What is the purpose of this trial?

The study plans to enroll a total of 132 patients. The goal of this study is to measure pre-and post-music intervention changes in patients' vital signs, serum- and plasma-level biomarkers by broad-spectrum proteomics analysis, metabolic analysis, and perceived pain, anxiety, and mood states as measured by validated questionnaires (STAI-S, POMS-SF, and VASP). We will collect demographic information on each participant. Participants will also complete the Brief Musical Experience Questionnaire (BMEQ) to investigate potential links between susceptibility to music-induced anxiolysis and prior musical training, preference and exposure.

Research Team

Mei Rui, DMA

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

Effects of listening to music on pain intensity and pain distress after surgery: an intervention. [2022]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Music therapy for patients receiving spine surgery. [2014]

5. England pubmed.ncbi.nlm.nih.gov

Meta-analysis evaluating music interventions for anxiety and pain in surgery. [2019]

6. Germany pubmed.ncbi.nlm.nih.gov

Role of Music in a Plastic Surgery Setting: A Systematic Review and Meta-analysis. [2023]

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

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

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

Music proves therapeutic to pain levels. [2019]

9. Australia pubmed.ncbi.nlm.nih.gov

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

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

Music Therapy Increases Comfort and Reduces Pain in Patients Recovering From Spine Surgery. [2017]

11. Japan pubmed.ncbi.nlm.nih.gov

Effect of Music Therapy on the Chronic Pain and Midterm Quality of Life of Patients after Mechanical Valve Replacement. [2020]