Systemic Lupus Erythematosus
Conditions
Keywords
SLE, Reiki
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.
Interventions
OTHERVirtual Reiki Therapy
20-minute session once per week for 8 weeks via Webex. Each session will be delivered remotely by a Certified Reiki Practitioner Level II or higher.
Sponsors
NYU Langone Health
Daisy Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult aged 18 and older at the time of informed consent 2. Diagnosed with SLE (based on 2019 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria) 3. Currently receiving SOC treatment for SLE at NYU Langone Orthopedic Center 4. Able and willing to provide consent and participate in 8 weekly virtual Reiki sessions 5. Has access to reliable internet, have an active email address, and able to utilize WebEx 6. Able to read, speak and understand English
Exclusion criteria
1. Under 18 years of age 2. Patients experiencing severe disease activity requiring hospitalization at time of screening 3. Unable to read, speak and understand English 4. No access to internet 5. Not willing to participate in weekly virtual Reiki sessions 6. Currently enrolled in another interventional clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analog Scales (VAS) score | Baseline, Week 4 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMonica Gamez-Perez, RN, BSN
NYU Langone Health
Outcome results
None listed