Music and Surgery Associated With Relationship and Satisfaction
MARS
The Effects of Personalized Music Therapy to Reduce Patient Anxiety for Surgery on Patient-doctor Relationship and Patient Satisfaction
1 other identifier
interventional
304
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Sep 2020
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedFirst Posted
Study publicly available on registry
September 18, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedOctober 6, 2020
October 1, 2020
1.3 years
September 9, 2020
October 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change between anxiety scales on of about 15 minutes from immediately after entering the operating room to just before induction of anesthesia.
Secondary Outcomes (4)
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.
Changes in anxiety scale II
Changes in the anxiety scale from the evening before surgery to 2 days after surgery.
Patient-Doctor Depth-of-Relationship Scale(PDDR)
The PDDR score measured at 2 days after surgery.
Satisfaction for surgery
The questionnaire about satisfaction is measured 2 days after surgery and 2 weeks after surgery.
Other Outcomes (1)
The participant's baseline depression score.
This score is measured at the evening before surgery.
Study Arms (2)
Music therapy group
EXPERIMENTALOne 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.
Control group
NO INTERVENTIONThe 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.
Interventions
Music selected according to the patient's individual preferences.
Eligibility Criteria
You may qualify if:
- Patient with breast cancer
- Patients scheduled for surgery under general anesthesia
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, 05505, South Korea
Related Publications (5)
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.
PMID: 26282640BACKGROUNDBradt 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.
PMID: 27524661BACKGROUNDBeesley 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.
PMID: 22475685BACKGROUNDRidd 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.
PMID: 22084265BACKGROUNDBayrak 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.
PMID: 31455484BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 18, 2020
Study Start
September 21, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
October 6, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share