Adjunctive Yu-Tone Music Therapy for Systemic Lupus Erythematosus: a Prospective Cohort Study
Traditional Chinese Five-Tone Therapy As an Adjunctive Treatment for Systemic Lupus Erythematosus: a Prospective Cohort Study
1 other identifier
observational
160
1 country
1
Brief Summary
The goal of this observational study is to investigate the long-term adjunctive effects of Traditional Chinese Five-Tone Therapy (Yu Tone) in patients with systemic lupus erythematosus (SLE). The main question it aims to answer is: Does Yu-tone music therapy improve psychological well-being and quality of life in SLE patients when used as a complementary intervention alongside standard pharmacotherapy? Participants already receiving Yu-tone music therapy as part of their integrative care for SLE will complete validated online questionnaires assessing psychological distress (e.g., anxiety, depression), disease-related quality of life, and medication adherence monthly for 2 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2025
CompletedFirst Submitted
Initial submission to the registry
March 21, 2025
CompletedFirst Posted
Study publicly available on registry
March 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
March 27, 2025
March 1, 2025
1.6 years
March 21, 2025
March 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
SLEDAI score
From enrollment to the treatment at 12 weeks
Study Arms (2)
Control group
No Yu-tone music intervention, receiving conventional pharmacotherapy only.
Yu-Tone Music Intervention Group
In addition to conventional pharmacotherapy, SLE patients receive a structured Yu-tone music listening program
Interventions
SLE patients undergo a structured Yu-tone music listening program (30 minutes daily, 5 days per week, with each cycle lasting 8 weeks, for a total of 3 cycles
Standard SLE medications (e.g., hydroxychloroquine, glucocorticoids).
Eligibility Criteria
Study Population are Chinese
You may qualify if:
- Meet the 2019 ACR/EULAR classification criteria for SLE; ② Adults aged 18 years or older; ③ Provide informed consent to participate in the study.
You may not qualify if:
- Presence of severe organ dysfunction (e.g., renal failure, cardiac insufficiency) or psychiatric disorders; ② Diagnosed with hearing impairment or auditory disorders; ③ Inability to comprehend or complete study questionnaires (e.g., due to cognitive impairment or language barriers).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yijun Luolead
Study Sites (1)
Hangzhou, 310053, China.
Hangzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD Candidate
Study Record Dates
First Submitted
March 21, 2025
First Posted
March 27, 2025
Study Start
March 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
January 1, 2027
Last Updated
March 27, 2025
Record last verified: 2025-03