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Music and Surgery Associated With Relationship and Satisfaction (MARS)

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Music therapy
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer, Music therapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music therapy group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in anxiety scale
An 11-point Numeric rating scale based on patient statements with 0 point for no anxiety and 10 for extreme anxiety.

Secondary Outcome Measures

Changes in anxiety scale over time
An 11-point Numeric rating scale based on patient statements with 0 point for no anxiety and 10 for extreme anxiety.
Changes in anxiety scale II
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.
Patient-Doctor Depth-of-Relationship Scale(PDDR)
A single overall depth-of-relationship score can be calculated, which ranges from 0 (no relationship) to 32 (very strong relationship).
Satisfaction for surgery
An 11-point scores measured through the questionnaire range from 0 (if not satisfied at all) to 10 (very satisfied).

Full Information

First Posted
September 9, 2020
Last Updated
October 3, 2020
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04555057
Brief Title
Music and Surgery Associated With Relationship and Satisfaction
Acronym
MARS
Official Title
The Effects of Personalized Music Therapy to Reduce Patient Anxiety for Surgery on Patient-doctor Relationship and Patient Satisfaction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, Music therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
304 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Music therapy
Intervention Description
Music selected according to the patient's individual preferences.
Primary Outcome Measure Information:
Title
Change in anxiety scale
Description
An 11-point Numeric rating scale based on patient statements with 0 point for no anxiety and 10 for extreme anxiety.
Time Frame
Change between anxiety scales on of about 15 minutes from immediately after entering the operating room to just before induction of anesthesia.
Secondary Outcome Measure Information:
Title
Changes in anxiety scale over time
Description
An 11-point Numeric rating scale based on patient statements with 0 point for no anxiety and 10 for extreme anxiety.
Time Frame
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.
Title
Changes in anxiety scale II
Description
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.
Time Frame
Changes in the anxiety scale from the evening before surgery to 2 days after surgery.
Title
Patient-Doctor Depth-of-Relationship Scale(PDDR)
Description
A single overall depth-of-relationship score can be calculated, which ranges from 0 (no relationship) to 32 (very strong relationship).
Time Frame
The PDDR score measured at 2 days after surgery.
Title
Satisfaction for surgery
Description
An 11-point scores measured through the questionnaire range from 0 (if not satisfied at all) to 10 (very satisfied).
Time Frame
The questionnaire about satisfaction is measured 2 days after surgery and 2 weeks after surgery.
Other Pre-specified Outcome Measures:
Title
The participant's baseline depression score.
Description
Measurement of patient baseline depression using Center for Epidemiologic Studies Depression Scale (CES-D). Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology.
Time Frame
This score is measured at the evening before surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yohan Joo, MD
Phone
82-02-3010-1682
Email
fermatic4620@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yohan Joo, MD
Phone
82-02-3010-1685
Email
fermatic4620@gmail.com
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohan Joo, MD
Phone
82-02-3010-1682
Email
fermatic4620@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26282640
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.
Results Reference
background
PubMed Identifier
27524661
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.
Results Reference
background
PubMed Identifier
22475685
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.
Results Reference
background
PubMed Identifier
22084265
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.
Results Reference
background
PubMed Identifier
31455484
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.
Results Reference
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Music and Surgery Associated With Relationship and Satisfaction

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