Music as a Perioperative Therapy in Breast Cancer Patients
Klíčová slova
Abstraktní
Popis
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.
Termíny
| Poslední ověření: | 06/30/2019 |
| První předloženo: | 03/13/2018 |
| Odhadovaná registrace vložena: | 04/16/2018 |
| První zveřejnění: | 04/26/2018 |
| Poslední aktualizace byla odeslána: | 07/09/2019 |
| Poslední aktualizace zveřejněna: | 07/11/2019 |
| Aktuální datum zahájení studie: | 07/09/2019 |
| Odhadované datum dokončení primární: | 06/30/2020 |
| Odhadované datum dokončení studie: | 06/30/2020 |
Stav nebo nemoc
Intervence / léčba
Behavioral: Music
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| Experimental: Music This group will be given a subscription to Pandora Plus for the duration of the study. Beginning two nights before surgery, they will listen to a music playlist they created for 30 minutes prior to going to sleep. This will continue each night with the final time being 6 nights after surgery. | 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. |
| No Intervention: Control This group will not listen to music each night for the duration of the study. |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 18 Years Na 18 Years |
| Pohlaví způsobilá ke studiu | Female |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | Inclusion Criteria: - Diagnosis of stage 0 to stage III breast cancer as classified by the American Joint Committee on Cancer - Undergoing a mastectomy or lumpectomy at Penn State Hershey Medical Center - Fluent in written and spoken English Exclusion Criteria: - Hearing loss or other difficulties hearing that, in the opinion of the research team, prevent the subject from listening to music - Serious oral health or dental conditions that affect saliva production - Patients who have undergone pre-operative chemotherapy or pre-operative radiation therapy - Should not be taking supplements of melatonin or taking corticosteroids - History of liver cancer - History of liver disease or cirrhosis (based on MELD score) - History of endocrine tumors - Lack of electronic device (smartphone, computer, etc) on which to listen to music - Cognitive impairment - Prisoner |
Výsledek
Primární výsledná opatření
1. Change in Pain [The survey will be given three days prior to surgery and seven days after surgery.]
2. Change in Sleep Quality [The scale will given three days prior to surgery and seven days after surgery.]
3. Change in Depression [The questionnaire will be given three days prior to surgery and seven days after surgery.]
Měření sekundárních výsledků
1. Change in Salivary Cortisol level [Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).]
2. Change in Salivary Melatonin level [Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).]
3. Change in Salivary C-reactive protein level [Samples will be taken two days before surgery (AM and PM), the day of surgery (AM only), one day after surgery (AM and PM), and seven days after surgery (AM and PM).]
