Systemic Lupus ErythematosusNCT06898489
Adjunctive Yu-Tone Music Therapy for Systemic Lupus Erythematosus: a Prospective Cohort Study
An observational study of Systemic Lupus Erythematosus and Music Therapy, run by Yijun Luo at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus, Music Therapy
- What is being tested?
- Yu-Tone Music Intervention and Conventional pharmacotherapy
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study Population are Chinese
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Systemic Lupus Erythematosus, Music Therapy
- Being tested
- Yu-Tone Music Intervention, Conventional pharmacotherapy
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yu-Tone Music InterventionCombination product
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
Conventional pharmacotherapyDrug
Standard SLE medications (e.g., hydroxychloroquine, glucocorticoids).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No Yu-tone music intervention, receiving conventional pharmacotherapy only. Receives: Drug: Conventional pharmacotherapy | |
| Yu-Tone Music Intervention Group | In addition to conventional pharmacotherapy, SLE patients receive a structured Yu-tone music listening program Receives: Combination Product: Yu-Tone Music Intervention; Drug: Conventional pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLEDAI score
Measured: From enrollment to the treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Mar 2025
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yijun Luo
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yijun Luo, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898489
- Sponsor's protocol ID
- 20250228-3
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Five-Tone Therapy As an Adjunctive Treatment for Systemic Lupus Erythematosus: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06898489
- Acronym / sponsor ID
- 20250228-3
- Conditions
- Systemic Lupus Erythematosus, Music Therapy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Yijun LuoOther government
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Drug: Conventional pharmacotherapyNo Yu-tone music intervention, receiving conventional pharmacotherapy only. |
| Yu-Tone Music Intervention Group | – | Combination Product: Yu-Tone Music Intervention, Drug: Conventional pharmacotherapyIn addition to conventional pharmacotherapy, SLE patients receive a structured Yu-tone music listening program |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study Population are Chinese
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yu-Tone Music InterventionSLE 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 | Combination product | Yu-Tone Music Intervention Group |
| Conventional pharmacotherapyStandard SLE medications (e.g., hydroxychloroquine, glucocorticoids). | Drug | Control group, Yu-Tone Music Intervention Group |
Primary outcome
SLEDAI score
Time frame: From enrollment to the treatment at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Music Therapy, run by Yijun Luo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLEDAI score (time frame: From enrollment to the treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.