132 Participants Needed

Music Therapy for Pre-operative Stress and Pain

MR
Overseen ByMei Rui, DMA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.14678

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.1791011

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

MR

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
See 2 more

Exclusion Criteria

I am deaf or have a hearing disability.
I am under 18 years old.
Patient was previously enrolled in the study
See 5 more

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
3Treatment groups
Experimental Treatment
Group I: Patients: Simulated Live MusicExperimental Treatment1 Intervention
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Group II: Patients: Recorded MusicExperimental Treatment1 Intervention
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.
Group III: Patients: Control: No MusicExperimental Treatment1 Intervention
Patients will be screened for eligibility, enrolled in the study and randomized 1:1:1.

Find a Clinic Near You

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.
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.
Effects of listening to music on pain intensity and pain distress after surgery: an intervention.Vaajoki, A., Pietilรค, 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.
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]

References

The anxiety- and pain-reducing effects of music interventions: a systematic review. [2022]
Effects of listening to music on pain intensity and pain distress after surgery: an intervention. [2022]
Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. [2023]
Music therapy for patients receiving spine surgery. [2014]
Meta-analysis evaluating music interventions for anxiety and pain in surgery. [2019]
Role of Music in a Plastic Surgery Setting: A Systematic Review and Meta-analysis. [2023]
Music versus distraction for procedural pain and anxiety in patients with cancer. [2018]
Music proves therapeutic to pain levels. [2019]
The Joanna Briggs Institute Best Practice Information Sheet: music as an intervention in hospitals. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Music Therapy Increases Comfort and Reduces Pain in Patients Recovering From Spine Surgery. [2017]
Effect of Music Therapy on the Chronic Pain and Midterm Quality of Life of Patients after Mechanical Valve Replacement. [2020]
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