Music and Surgery Associated With Relationship and Satisfaction

Not Applicable

• Conditions: Breast Cancer
• Interventions: Procedure: Music therapy

• Registration Number: NCT04555057
• Lead Sponsor: Asan Medical Center

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.

Study Timeline

• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-18
• Study Start: 2020-09-21
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-03
• Last Update Posted: 2020-10-06
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music therapy group	Music therapy	One day before surgery, the participants of music therapy group choose the music they want to listen in the operating room. The total playing time of the selected music is recommended between 5 and 10 minutes. On the day of surgery, after entering the operating room, listen to personally selected music through the speaker. After the music is over, start anesthesia induction.

Primary Outcome Measures

Name	Time	Method
Change in anxiety scale	Change between anxiety scales on of about 15 minutes from immediately after entering the operating room to just before induction of anesthesia.	An 11-point Numeric rating scale based on patient statements with 0 point for no anxiety and 10 for extreme anxiety.

Secondary Outcome Measures

Name	Time	Method
Patient-Doctor Depth-of-Relationship Scale(PDDR)	The PDDR score measured at 2 days after surgery.	A single overall depth-of-relationship score can be calculated, which ranges from 0 (no relationship) to 32 (very strong relationship).
Changes in anxiety scale II	Changes in the anxiety scale from the evening before surgery to 2 days after surgery.	Anxiety scale measured using Generalized Anxiety Disorder 7-item (GAD-7) scale. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.; The measurement of anxiety scale in the operating room has no choice but to be measured with the Numeric rating scale(NRS) stated by the patient due to time constraints. However, since the NRS score can be different for each individual, we intend to compensate for errors by measuring and comparing NRS and GAD-7 together on the day before and 2 days after surgery.
Satisfaction for surgery	The questionnaire about satisfaction is measured 2 days after surgery and 2 weeks after surgery.	An 11-point scores measured through the questionnaire range from 0 (if not satisfied at all) to 10 (very satisfied).
Changes in anxiety scale over time	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.	An 11-point Numeric rating scale based on patient statements with 0 point for no anxiety and 10 for extreme anxiety.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of