Adjunctive Yu-Tone Music Therapy for Systemic Lupus Erythematosus: a Prospective Cohort Study

March 21, 2025 updated by: Yijun Luo

Traditional Chinese Five-Tone Therapy As an Adjunctive Treatment for Systemic Lupus Erythematosus: a Prospective Cohort Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

160

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
      • Hangzhou, China
        • Hangzhou, 310053, China.

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study Population are Chinese

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
No Yu-tone music intervention, receiving conventional pharmacotherapy only.
Drug: Conventional pharmacotherapy
Standard SLE medications (e.g., hydroxychloroquine, glucocorticoids).
Yu-Tone Music Intervention Group
In addition to conventional pharmacotherapy, SLE patients receive a structured Yu-tone music listening program
Drug: Conventional pharmacotherapy
Standard SLE medications (e.g., hydroxychloroquine, glucocorticoids).
Combination product: Yu-Tone Music Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SLEDAI score
Time Frame: From enrollment to the treatment at 12 weeks
From enrollment to the treatment at 12 weeks

Collaborators and Investigators

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

Sponsor

Yijun Luo

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)

March 1, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250228-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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