5-element Music Therapy on Patients With Breast Cancer

NCT ID: NCT04442035

Last Updated: 2020-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-25
• Study Completion Date: 2018-06-03

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.

Conditions

Breast Cancer Female; Quality of Life; Depression, Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

The teatment group

5-element misic therapy

Group Type: EXPERIMENTAL

5-element music therapy

Intervention Type: BEHAVIORAL

participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).

The control group

health education

Group Type: EXPERIMENTAL

5-element music therapy

Intervention Type: BEHAVIORAL

participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).

Interventions

5-element music therapy

participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).

Intervention Type: BEHAVIORAL

Other Intervention Names

health education

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.

• Minimum Eligible Age: 27 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zheng zhuanfang

Role: STUDY_CHAIR

Second Clinical College of Guangzhou University of Traditional Chinese Medicine

Locations

Guangdong Provincial Chinese medicine hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

B2016-043-01

Identifier Type: -

Identifier Source: org_study_id