NCT03511079

Music as a Perioperative Therapy in Breast Cancer Patients

Impact of Perioperative Music on Quality of Life Measures and Biomarker Levels in Breast Cancer Patients

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Music has often been used in hospitals as a therapy but there is a limited amount of research looking at how music actually affects the different molecules in the body, such as cortisol (a marker of stress). There is especially a lack of research in the context of surgery. The hope is that this study will show that music can be used to minimize some of the side effects related to breast surgery and improve the patient experience.

Detailed description

In medical practice, an ideal therapy should have maximal benefit with minimal risk. While considerable effort is being placed into discovering more effective pharmaceuticals, there is a growing field of interest in alternative therapies. In the 1970's, George Engle put forward the idea of the biopsychosocial response in which the patient's social and psychological factors can influence the body's biologic function and vice versa. One such potential therapy that could work by this mechanism is music. Advantages of music include low cost, availability, no required expertise, and minimal side effects. Studies have shown that music leads to reduced postoperative pain, anxiety, and analgesic needs in surgical patients. It has also been shown that patient selected music has greater outcomes than researcher selected music. While there is a significant body of literature on changes in clinical measurements, there are only two studies known to us which try to examine the effects of music on a molecular level, measuring cortisol and blood glucose respectively. Neither of these studies have been performed in patients undergoing surgery for breast cancer. On the other hand, considerable research is currently being conducted to determine biomarkers in the context of surgery that are associated with poor outcomes, especially in the context of breast surgery. Stress, usually associated with cortisol levels, has been associated with increased sleep disruption, increased metabolism, increased risk of thromboembolic events, and impaired wound healing in patients. In breast cancer patients, it has been found that C-reactive protein levels correlated in fatigue postoperatively and decreased diurnal variation in cortisol has been associated with depression. Melatonin, in general, is a marker for circadian rhythm and would also be representative of sleep disruption. C-reactive protein is primarily a marker of inflammation which in turn is associated with disease progression and poorer clinical outcomes in breast surgery patients. This study aims to determine both if music affects molecular mechanisms through measurement of clinical biomarkers as well as if there is an association with significant quality of life measures. A positive association could provide evidence into music being used as an adjunct therapy peri-operatively.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Music	Music will be delivered through Pandora Plus radio via patient's computer or smartphone. The patient will choose a favorite song to create a playlist which will be used for the duration of the entire study. The subgenre of the initial song will be recorded.

Timeline

• Start date: 2019-07-10
• Primary completion: 2021-10-27
• Completion: 2021-10-27
• First posted: 2018-04-27
• Last updated: 2021-11-04

Locations

1 site across 1 country: United States