Music as a Perioperative Therapy in Breast Cancer Patients

NCT03511079 | Withdrawn

• 1 other identifier: STUDY00007842
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Music

Outcome Measures

Primary Outcomes (3)

• Change in Pain

  Pain will be measured using select questions from the BREAST-Q model. The individual pain items will be measured on a 5 point Likert scale as follows: 1. = None of the time 2. = A little of the time 3. = Some of the time 4. = Most of the time 5. = All of the time Total summed scores range from 12 to 60 in breast conserving modules and 16 to 80 for mastectomy modules. Higher scores are representative of more pain experienced by the patient.

  The survey will be given three days prior to surgery and seven days after surgery.

• Change in Sleep Quality

  Sleep quality will be measured by the Karolinska Sleepiness scale. The KSS is a 9-point Likert scale often used when conducting studies involving self-reported, subjective assessment of an individual's level of drowsiness at the time. The KSS Scores are defined as follows: 9\. Extremely sleepy, fighting sleep 8. Sleepy, some effort to keep alert 7. Sleepy, but no difficulty remaining awake 6. Some signs of sleepiness 5. Neither alert nor sleepy 4. Rather alert 3. Alert 2. Very alert 1\. Extremely alert Higher values indicate a higher level of drowsiness.

  The scale will given three days prior to surgery and seven days after surgery.

• Change in Depression

  Depression will be measured with the Center for Epidemiologic Studies-Depression scale. The CES-D scale is a 20-item measure that measures how often over the past week one has experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Total summed scores range from 0 to 60, with high scores indicating greater depressive symptoms.

  The questionnaire will be given three days prior to surgery and seven days after surgery.

Secondary Outcomes (3)

• 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).

• 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).

• 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).

Study Arms (2)

Music

EXPERIMENTAL

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

Control

NO INTERVENTION

This group will not listen to music each night for the duration of the study.

Interventions

Music BEHAVIORAL

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.

Also known as: Pandora Plus

Music

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Breast Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (8)

• Borrell-Carrio F, Suchman AL, Epstein RM. The biopsychosocial model 25 years later: principles, practice, and scientific inquiry. Ann Fam Med. 2004 Nov-Dec;2(6):576-82. doi: 10.1370/afm.245.

  PMID: 15576544 BACKGROUND

• Hole J, Hirsch M, Ball E, Meads C. Music as an aid for postoperative recovery in adults: a systematic review and meta-analysis. Lancet. 2015 Oct 24;386(10004):1659-71. doi: 10.1016/S0140-6736(15)60169-6. Epub 2015 Aug 12.

  PMID: 26277246 BACKGROUND

• Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.

  PMID: 18395022 BACKGROUND

• Nilsson U, Unosson M, Rawal N. Stress reduction and analgesia in patients exposed to calming music postoperatively: a randomized controlled trial. Eur J Anaesthesiol. 2005 Feb;22(2):96-102. doi: 10.1017/s0265021505000189.

  PMID: 15816586 BACKGROUND

• Vetter D, Barth J, Uyulmaz S, Uyulmaz S, Vonlanthen R, Belli G, Montorsi M, Bismuth H, Witt CM, Clavien PA. Effects of Art on Surgical Patients: A Systematic Review and Meta-analysis. Ann Surg. 2015 Nov;262(5):704-13. doi: 10.1097/SLA.0000000000001480.

  PMID: 26583656 BACKGROUND

• Orre IJ, Reinertsen KV, Aukrust P, Dahl AA, Fossa SD, Ueland T, Murison R. Higher levels of fatigue are associated with higher CRP levels in disease-free breast cancer survivors. J Psychosom Res. 2011 Sep;71(3):136-41. doi: 10.1016/j.jpsychores.2011.04.003. Epub 2011 May 18.

  PMID: 21843747 BACKGROUND

• Bouchard LC, Antoni MH, Blomberg BB, Stagl JM, Gudenkauf LM, Jutagir DR, Diaz A, Lechner S, Gluck S, Derhagopian RP, Carver CS. Postsurgical Depressive Symptoms and Proinflammatory Cytokine Elevations in Women Undergoing Primary Treatment for Breast Cancer. Psychosom Med. 2016 Jan;78(1):26-37. doi: 10.1097/PSY.0000000000000261.

  PMID: 26569533 BACKGROUND

• Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.

  PMID: 2265922 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Kristine L Widders, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There will be no blinding in this study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: There will be two groups. The intervention group will listen to music each night several days before and after surgery. The control group will not listen to music each night around the time of surgery.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: April 27, 2018
• Study Start: July 10, 2019
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)