The Effect of Chinese Five-element Music

June 17, 2024 updated by: University of Malaya

he Effect of Chinese Five-element Music Based on Midnight-noon Ebb-flow Theory on Depression and Anxiety Among Older Adults

Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Depression and anxiety among the older adults is an issue that cannot be ignored at present. Compared to traditional pharmacological treatments and electroconvulsive therapy, non pharmacological treatments with fewer side effects, such as music-based intervention, are also effective and more easily accepted for the treatment of depression and anxiety in the older adults. In China, there have been some researches conducted Chinese five elements music as a clinical treatment for relieving depression and anxiety disorders in patients. However, there is few research on the impact of Chinese five elements music-based intervention based on midnight-noon ebb-flow theory on depression and anxiety in the older adults. This study investigated the intervention effect of Chinese five elements music-based intervention accompanied by midnight-noon ebb-flow theory on depression and anxiety in older adults. This study intervened in music-based intervention for 86 older adults with depression and anxiety, and divided the 86 subjects into an experimental group (with Chinese five elements music based on midnight-noon ebb-flow theory) and a control group (with Chinese five elements music). This study used the Hamilton Depression Scale, Hamilton Anxiety Scale, and the Quality of Life Enjoyment and Satisfaction Questionnaire as assessment instruments after the intervention. According to the evaluation results, it was found that compared with traditional Chinese five elements music, the intervention of Chinese five elements music with midnight-noon ebb-flow theory is more effective in alleviating depression in the older adults. This study will provide a scientific basis for further study of the timing mechanism of the five elements theory and further advance the benefits of Traditional Chinese Time Medicine.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hebei
      • Qinhuangdao, Hebei, China, 066000
        • Qinhuangdao No. 5 Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Participants' HAM-D scores should be greater than 8 and HAM-A scores should be greater than 7.
  2. Patients should be older than or equal to 60 years of age.
  3. Patients have no other psychiatric disorders and are not taking psychotropic medication to improve symptoms.
  4. They participate voluntarily in this experiment.

Exclusion Criteria:

  1. People who did not meet the diagnostic criteria. .
  2. Who have participated in other clinical trials within the last four weeks.
  3. Graduates of music studies or workers who are involved in music.
  4. People suffering from hearing impairment or other severe chronic psychiatric disorders.
  5. People who are under psychotropic medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
with Chinese five elements music based on midnight-noon ebb-flow theory
Other: Experimental
The experimental group intervened based on the midnight-noon ebb-flow theory, listening to music corresponding to the five organs at different time periods.
Placebo Comparator: control group
with Chinese five elements music
Other: Control
The control group listened to Chinese five elements music pieces from 13:00 to 18:00 p.m., each music piece for within 30 minutes for, 5 days per week, 4 weeks for a cycle, 3 cycles in total.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hamilton Depression Rating Scale (HAM-D)
Time Frame: 12 months
The 17 items of the original HAM-D measure the degree of depression, feelings of guilt, suicidal thoughts, insomnia, ability to work and be active, language and cognitive retardation, agitation, anxiety (psychological and somatic), gastrointestinal, genital or general symptoms, hypochondriasis, weight loss and awareness of illness. Similar to the HAM-A, more than half of the items have values between 0 and 4. All other values are between 0 and 2, with the exception of weight loss (0-3). Individuals who score between 0 and 7 are considered normal or in remission. According to UF Health (2011b), a total score of more than 20 is considered an indication of at least moderate to severe depression
12 months
Hamilton Anxiety Rating Scale (HAM-A)
Time Frame: 12 months
The 14 items of the HAM-A relate to psychological and somatic symptoms such as tension, insomnia, nervousness, depression and somatic symptoms. They also cover behavioral problems identified during the interview, such as restlessness or fidgeting, as well as problems with the respiratory tract, gastrointestinal tract, cardiovascular system, genitourinary system or autonomic system. With a total score of 0-56, each element is rated on a scale from 0 (not present) to 4 (extremely severe). According to UF Health (2011a), individuals who score between 0 and 7 are considered normal or in remission, a total score of less than 17 more than 7 indicates low anxiety, 18-24 indicates mild to moderate anxiety, and 25-30 indicates moderate to severe anxiety.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: wen fen beh, Phd, University Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Depression and Anxiety

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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