HEAL-SLE: Holistic Energy for Alleviating Lupus Symptoms
- Conditions
- Systemic Lupus Erythematosus
- Registration Number
- NCT07203157
- Lead Sponsor
- NYU Langone Health
- Brief Summary
The purpose of this study is to assess the efficacy, feasibility, and acceptability of Virtual Reiki therapy as a complementary treatment for patients with systemic lupus erythematosus (SLE). The study also aims to investigate the feasibility, acceptability, and adherence of integrating Virtual Reiki therapy within the healthcare system for patients with SLE. Participants receiving standard of care (SOC) treatment for SLE will continue SOC while receiving research-specific Virtual Reiki therapy once per week for 8 weeks. Each study session will be delivered remotely by a Certified Reiki Practitioner Level II or higher.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Adult aged 18 and older at the time of informed consent
- Diagnosed with SLE (based on 2019 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria)
- Currently receiving SOC treatment for SLE at NYU Langone Orthopedic Center
- Able and willing to provide consent and participate in 8 weekly virtual Reiki sessions
- Has access to reliable internet, have an active email address, and able to utilize WebEx
- Able to read, speak and understand English
- Under 18 years of age
- Patients experiencing severe disease activity requiring hospitalization at time of screening
- Unable to read, speak and understand English
- No access to internet
- Not willing to participate in weekly virtual Reiki sessions
- Currently enrolled in another interventional clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Change in Visual Analog Scales (VAS) score Week 4, Week 8 VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
- Secondary Outcome Measures
Name Time Method Number of Reiki sessions completed over the 8-week period Week 8 Adherence will be measured using a reiki visit log to monitor the number of Reiki sessions completed over the 8- week period. Participants completing fewer than 75% of scheduled sessions (fewer than 6 out of 8 sessions) will be excluded from the final analysis to ensure study data integrity.
Trial Locations
- Locations (1)
NYU Langone Health
πΊπΈNew York, New York, United States
NYU Langone HealthπΊπΈNew York, New York, United States