Breast CancerMARSNCT04555057
Music and Surgery Associated With Relationship and Satisfaction
A study testing Music therapy in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Music therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with breast cancer
- Patients scheduled for surgery under general anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Yohan Joo, MD, 82-02-3010-1682, fermatic4620@gmail.com
About this study
Official title: The Effects of Personalized Music Therapy to Reduce Patient Anxiety for Surgery on Patient-doctor Relationship and Patient Satisfaction
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Music therapy
- Keywords
- Breast cancer, Music therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyProcedure or surgery
Music selected according to the patient's individual preferences.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy group | Experimental | 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. Receives: Procedure: Music therapy |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
An 11-point Numeric rating scale based on patient statements with 0 point for no anxiety and 10 for extreme anxiety.
Measured: 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
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.
Measured: Changes in the anxiety scale from the evening before surgery to 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).
Measured: The PDDR score measured at 2 days after surgery.
Satisfaction for surgery
An 11-point scores measured through the questionnaire range from 0 (if not satisfied at all) to 10 (very satisfied).
Measured: The questionnaire about satisfaction is measured 2 days after surgery and 2 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start21 Sep 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yohan Joo, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555057
- Sponsor's protocol ID
- 2020-1243
- Acronym
- MARS
- Status last verified
- Oct 2020
- First submitted
- 9 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26282640Bradt 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.
PubMed 27524661Beesley 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.
PubMed 22475685Ridd 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.
PubMed 22084265Bayrak 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.
PubMed 31455484
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Personalized Music Therapy to Reduce Patient Anxiety for Surgery on Patient-doctor Relationship and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT04555057
- Acronym / sponsor ID
- MARS / 2020-1243
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Music therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy group | Experimental | Procedure: Music therapyOne 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 intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with breast cancer
- Patients scheduled for surgery under general anesthesia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyMusic selected according to the patient's individual preferences. | Procedure or surgery | Music therapy group |
Primary outcome
Change in anxiety scale
Time frame: 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.
4 secondary outcomes
Changes in anxiety scale over time
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.
Changes in anxiety scale II
Time frame: Changes in the anxiety scale from the evening before surgery to 2 days after surgery.
Patient-Doctor Depth-of-Relationship Scale(PDDR)
Time frame: The PDDR score measured at 2 days after surgery.
Satisfaction for surgery
Time frame: The questionnaire about satisfaction is measured 2 days after surgery and 2 weeks after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Background: PubMed 26282640Palmer 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.
- Background: PubMed 27524661Bradt 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.
- Background: PubMed 22475685Beesley 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.
- Background: PubMed 22084265Ridd 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.
- Background: PubMed 31455484Bayrak 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.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Breast Cancer
Not yet recruitingPhase 1
Safety and Biodistribution of [68Ga]Ga DOTA-5G in Subjects With Metastatic Breast Cancer (BC)
Metastatic Breast Cancer
Active, not recruiting
Peer Navigator Education in Improving Survivorship Care in African American Breast Cancer Survivors
Breast Cancer
RecruitingObservational study
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Quality of Life, Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Breast Cancer, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yohan Joo, MD (82-02-3010-1682, fermatic4620@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety scale (time frame: Change between anxiety scales on of about 15 minutes from immediately after entering the operating room to just before induction of anesthesia.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555057, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.