The Effect of Chinese Five-element Music

NCT06472154 | Completed DMC

• 1 other identifier: Depression and Anxiety
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Anxiety

Keywords

Depression; Anxiety; older adults; Chinese five elements music-based intervention; Midnight-noon ebb-flow

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale (HAM-D)

  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)

  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

Study Arms (2)

experimental group

EXPERIMENTAL

with Chinese five elements music based on midnight-noon ebb-flow theory

Other: Experimental

control group

PLACEBO COMPARATOR

with Chinese five elements music

Other: Control

Interventions

Experimental OTHER

The experimental group intervened based on the midnight-noon ebb-flow theory, listening to music corresponding to the five organs at different time periods.

experimental group

Control OTHER

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.

control group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Qinhuangdao No. 5 Hospital

Qinhuangdao, Hebei, 066000, China

Location

Related Publications (1)

• Li J, Beh WF, Wang IT, Wu Y. The effect of Chinese 5-element music with midnight-noon ebb-flow theory on depression, anxiety, quality of life satisfaction among older adults: A randomized controlled trial. Medicine (Baltimore). 2025 Jan 3;104(1):e41224. doi: 10.1097/MD.0000000000041224.

  PMID: 40184117 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• wen fen beh, Phd

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 24, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 24, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)