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

Active, not recruiting

• Conditions: Systemic Lupus Erythematosus; Music Therapy
• Interventions: Drug: Conventional pharmacotherapy; Combination Product: Yu-Tone Music Intervention

• Registration Number: NCT06898489
• Lead Sponsor: Yijun Luo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Primary Completion: 2026-10
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Conventional pharmacotherapy	No Yu-tone music intervention, receiving conventional pharmacotherapy only.
Yu-Tone Music Intervention Group	Yu-Tone Music Intervention	In addition to conventional pharmacotherapy, SLE patients receive a structured Yu-tone music listening program
Yu-Tone Music Intervention Group	Conventional pharmacotherapy	In addition to conventional pharmacotherapy, SLE patients receive a structured Yu-tone music listening program

Primary Outcome Measures

Name	Time	Method
SLEDAI score	From enrollment to the treatment at 12 weeks

Trial Locations

Locations (1)

Hangzhou, 310053, China.; 🇨🇳 Hangzhou, China