HEAL-SLE: Holistic Energy for Alleviating Lupus Symptoms
HEAL-SLE
A Pilot Study Evaluating the Effect and Feasibility of Virtual Reiki Therapy as a Complementary Treatment for Patients With Systemic Lupus Erythematosus
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2025
CompletedFirst Posted
Study publicly available on registry
October 2, 2025
CompletedStudy Start
First participant enrolled
October 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2026
ExpectedOctober 2, 2025
September 1, 2025
6 months
September 24, 2025
September 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Visual Analog Scales (VAS) score
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.
Baseline, Week 4
Change in Visual Analog Scales (VAS) score
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.
Week 4, Week 8
Secondary Outcomes (1)
Number of Reiki sessions completed over the 8-week period
Week 8
Study Arms (1)
Virtual Reiki Therapy
EXPERIMENTALParticipants receiving standard of care (SOC) treatment for SLE will continue SOC while receiving research-specific Virtual Reiki therapy once per week for 8 weeks.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Daisy Foundationcollaborator
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monica Gamez-Perez, RN, BSN
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2025
First Posted
October 2, 2025
Study Start
October 15, 2025
Primary Completion
March 31, 2026
Study Completion (Estimated)
September 20, 2026
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Monica.Gamez-Perez@NYULangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Monica.Gamez-Perez@NYULangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.