- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06472154
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
86
Phase
- 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
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants' HAM-D scores should be greater than 8 and HAM-A scores should be greater than 7.
- Patients should be older than or equal to 60 years of age.
- Patients have no other psychiatric disorders and are not taking psychotropic medication to improve symptoms.
- They participate voluntarily in this experiment.
Exclusion Criteria:
- People who did not meet the diagnostic criteria. .
- Who have participated in other clinical trials within the last four weeks.
- Graduates of music studies or workers who are involved in music.
- People suffering from hearing impairment or other severe chronic psychiatric disorders.
- 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 |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group
with Chinese five elements music based on midnight-noon ebb-flow theory
|
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
|
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
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
Investigators
- 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)
January 1, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
June 12, 2024
First Submitted That Met QC Criteria
June 17, 2024
First Posted (Actual)
June 24, 2024
Study Record Updates
Last Update Posted (Actual)
June 24, 2024
Last Update Submitted That Met QC Criteria
June 17, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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