Music and Surgery Associated With Relationship and Satisfaction

NCT ID: NCT04555057

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Music therapy group

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.

Group Type EXPERIMENTAL

Music therapy

Intervention Type PROCEDURE

Music selected according to the patient's individual preferences.

Control group

The participants of control group wear earmuff to block noise after entering the operating room until induction of anesthesia. All other treatments proceed as conventional treatments.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music therapy

Music selected according to the patient's individual preferences.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yohan Joo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yohan Joo, MD

Role: CONTACT

82-02-3010-1682

Yohan Joo, MD

Role: CONTACT

82-02-3010-1685

Facility Contacts

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Yohan Joo, MD

Role: primary

82-02-3010-1682

References

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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.

Reference Type BACKGROUND
PMID: 26282640 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27524661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22475685 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22084265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31455484 (View on PubMed)

Other Identifiers

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2020-1243

Identifier Type: -

Identifier Source: org_study_id

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