Clinical trial · Interventional
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
NCT03511079CI-TRIAL-00054887withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty with recruiting due to staffing and Covid-19
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Music | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Music
- description
- 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.
- interventionNames
- Behavioral: Music
- type
- NO_INTERVENTION
- label
- Control
- description
- This group will not listen to music each night for the duration of the study.
Primary outcomes (3)
- measure
- Change in Pain
- timeFrame
- The survey will be given three days prior to surgery and seven days after surgery.
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (8)
- BACKGROUNDBorrell-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
- BACKGROUNDHole 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
- BACKGROUNDNilsson 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
- BACKGROUNDNilsson 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
- BACKGROUNDVetter 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
- BACKGROUNDOrre 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
- BACKGROUNDBouchard 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.