Clinical trial NCT04442035: 5-element Music Therapy on Patients With Breast Cancer
Official title: Clinical Efficacy Study on 5-element Music Therapy on Patients With Physically and Psychologically Unbalance After Breast Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Quality of Life
Depression, Anxiety
Keywords: breast cancer
music therapy
Quality of Life
Depression, Anxiety
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-06-22
Enrollment: 64
Sex: FEMALE
Minimum age (years): 27
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we observed the clinical effect of using music therapy of TCM to improve the status of liver depression in patients with postoperative breast cancer patients, Second we want to explore the efficacy and advantages of traditional Chinese medicine in patients with postoperative breast cancer, and to reveal the clinical use of the efficacy and superiority.

Detailed description: The study is a prospective controlled trial. Sixty-four patients were divided randomly into two groups. Patients were randomly divided into the treatment group and the control group, namely, the music treatment group and the health education group. The treatment group was given at least 30 minutes of individual music therapy and group music therapy every 3 weeks. Instead, the control group was given every 3 weeks of health education preach. It will take 12 weeks for treatment and observation. The efficacy was evaluated by observing the beginning and end of the trial of the Self-Rating Anxiety Scale score, the Self-Rating Depression Scale score, and the Breast Cancer Patients' Quality of Life Scale. At the end of the treatment, we take software packages SPSS 20.0 for management and statistical analysis.

Eligibility criteria: Inclusion Criteria:

* the diagnosis of breast cancer in clinical stage (Ⅰ, Ⅱ, Ⅲ) and postoperative breast cancer during one month;
* All participants had to have clinical depression and stagnation of liver qi;
* age 27-66;
* participants are conscious and willing to be followed up during the treatment.

Exclusion Criteria:

* Metastasis of breast cancer or serious complications;
* Patients with major depressive disorder;
* The past medical history of mental disorders;
* The primary diseases including liver, kidney, cerebrovascular, cardiovascular and hematopoietic system diseases;
* Participating in another clinical study or undergoing another intervention;
* Patients with hearing loss.

Primary outcomes:
measure: Change From Baseline in Self-Rating Anxiety Scale (SAS) score at 3 Months
timeFrame: Baseline and months 3
measure: Change From Baseline in Self-Rating Depression Scale(SDS) score at 3 Months
timeFrame: Baseline and months 3
measure: Change From Baseline in Quality of Life (FACT-B score) at 3 Months
timeFrame: Baseline and months 3
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Chinese medicine hospital
state: Guangdong
Study officials:
affiliation: Second Clinical College of Guangzhou University of Traditional Chinese Medicine
name: Zheng zhuanfang
role: STUDY_CHAIR
References: