Clinical trial NCT04555057: Music and Surgery Associated With Relationship and Satisfaction
Official title: The Effects of Personalized Music Therapy to Reduce Patient Anxiety for Surgery on Patient-doctor Relationship and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
Music therapy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this study, the investigators want to check whether it has a direct effect on the participants first, and secondly, whether it affects the relationship between the patient and the doctor or treatment satisfaction, by reducing the anxiety of patients before surgery through music therapy.

Detailed description: Patients often experience anxiety before surgery. They feel anxious for a number of reasons, such as worrying about the state of the disease they are diagnosed with, discomfort about the unfamiliar hospital environment, whether the operation is safe or it will be painful after surgery. In particular, anxiety related to surgery increases as the date and time of surgery approaches, and is most heightened just before surgery.

Persistent anxiety can lead to depression by triggering negative emotions, may also contribute to low compliance with overall treatment, and leading to low quality of life (QoL).

For this reason, various alternative treatments have been attempted to reduce the patient's stress, and music therapy is one of them. Music therapy can significantly reduce anxiety in patients before surgery. In addition, through many attempts so far, the possibility of affecting pain or quality of life after surgery has been confirmed. However, the results of studies are still inconsistent and evidence is not clear about the additional effects that can be obtained through patient anxiety reduction. Therefore, more earnest and practical research is required on additional effects and utilization through music therapy.

The investigators realized the possibility that listening to music to a patient before anesthesia in an operating room could not only reduce anxiety for the patient, but also provide an opportunity to improve the relationship with the doctor. Listening to music in the operating room is an impressive experience for the patient, and it can be an opportunity to make a positive impression on the medical staff who prepared it. This has the potential to improve the relationship between patients and doctors who need to continue to meet for additional treatment in the future.

According to a study by H. Beesley et al., in 40% of patients after breast reconstruction surgery, there was a difference between the satisfaction of the surgery and the cosmetic evaluation of the medical staff, and the relationship between the patient and the medical staff was evaluated to have an effect on this. A good relationship with a doctor or medical staff can lead to high satisfaction in patients with a low beauty score, and conversely, a poor relationship with a medical staff can lead to low satisfaction. This can be considered the possibility that if the patient-doctor relationship is improved through music therapy, the patient's satisfaction with surgery or treatment can also be increased.

The investigators will see how much anxiety can be reduced by listening to pre-operative music to patients. In addition, Researchers will evaluate the depth of the relationship between the patient and the doctor and find out whether there is a correlation with the patient's satisfaction with surgery.

Eligibility criteria: Inclusion Criteria:

* Patient with breast cancer
* Patients scheduled for surgery under general anesthesia

Exclusion Criteria:

* Patients with serious mental illness accompanied by cognitive impairment that makes voluntary independent judgment or social life impossible
* Patients with hearing impairment that makes it impossible to listen to music
* Patients with distant metastasis confirmed and performed as a palliative surgery

Primary outcomes:
measure: Change in anxiety scale
timeFrame: Change between anxiety scales on of about 15 minutes from immediately after entering the operating room to just before induction of anesthesia.
Secondary outcomes:
measure: Changes in anxiety scale over time
timeFrame: Changes in the anxiety scale at 4 time points from the evening before surgery to immediately after entering the operating room on the day of surgery, immediately before induction of anesthesia, and 2 days after surgery.
measure: Changes in anxiety scale II
timeFrame: Changes in the anxiety scale from the evening before surgery to 2 days after surgery.
measure: Patient-Doctor Depth-of-Relationship Scale(PDDR)
timeFrame: The PDDR score measured at 2 days after surgery.
measure: Satisfaction for surgery
timeFrame: The questionnaire about satisfaction is measured 2 days after surgery and 2 weeks after surgery.
Other outcomes:
measure: The participant's baseline depression score.
timeFrame: This score is measured at the evening before surgery.
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
citation: Palmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17.
citation: Bradt J, Dileo C, Magill L, Teague A. Music interventions for improving psychological and physical outcomes in cancer patients. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD006911. doi: 10.1002/14651858.CD006911.pub3.
citation: Beesley H, Ullmer H, Holcombe C, Salmon P. How patients evaluate breast reconstruction after mastectomy, and why their evaluation often differs from that of their clinicians. J Plast Reconstr Aesthet Surg. 2012 Aug;65(8):1064-71. doi: 10.1016/j.bjps.2012.03.005. Epub 2012 Apr 3.
citation: Ridd MJ, Lewis G, Peters TJ, Salisbury C. Patient-doctor depth-of-relationship scale: development and validation. Ann Fam Med. 2011 Nov-Dec;9(6):538-45. doi: 10.1370/afm.1322.
citation: Bayrak A, Sagiroglu G, Copuroglu E. Effects of Preoperative Anxiety on Intraoperative Hemodynamics and Postoperative Pain. J Coll Physicians Surg Pak. 2019 Sep;29(9):868-873. doi: 10.29271/jcpsp.2019.09.868.