Systemic Lupus ErythematosusHEAL-SLENCT07203157
HEAL-SLE: Holistic Energy for Alleviating Lupus Symptoms
A study testing Virtual Reiki Therapy in people with Systemic Lupus Erythematosus, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Virtual Reiki Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to 31 Oct 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Effect and Feasibility of Virtual Reiki Therapy as a Complementary Treatment for Patients With Systemic Lupus Erythematosus
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Virtual Reiki Therapy
- Keywords
- SLE, Reiki
- 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.
Virtual Reiki TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reiki Therapy | Experimental | 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. Receives: Other: Virtual Reiki Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 4, Week 8
Secondary outcomes (1)
Number of Reiki sessions completed over the 8-week period
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.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start3 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completion31 Oct 2026 (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.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Daisy Foundation
- Responsible party
- Sponsor
- Investigators
- Monica Gamez-Perez, RN, BSN, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203157
- Sponsor's protocol ID
- 25-00357
- Acronym
- HEAL-SLE
- Status last verified
- Aug 2026
- First submitted
- 24 Sep 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating the Effect and Feasibility of Virtual Reiki Therapy as a Complementary Treatment for Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07203157
- Acronym / sponsor ID
- HEAL-SLE / 25-00357
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, Reiki
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Daisy Foundation
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 2 Oct 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reiki Therapy | Experimental | Other: Virtual Reiki TherapyParticipants receiving standard of care (SOC) treatment for SLE will continue SOC while receiving research-specific Virtual Reiki therapy once per week for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Virtual Reiki Therapy20-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. | Other | Virtual Reiki Therapy |
Primary outcome
Change in Visual Analog Scales (VAS) score
Time frame: 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.
Change in Visual Analog Scales (VAS) score
Time frame: 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.
1 secondary outcome
Number of Reiki sessions completed over the 8-week period
Time frame: Week 8
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 12 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Monica Gamez-Perez, RN, BSN principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reiki Therapy in people with Systemic Lupus Erythematosus, run by NYU Langone Health at 1 site in United States.
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 6 inclusion and 6 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 12 Aug 2026. 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 United States. 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?
Change in Visual Analog Scales (VAS) score (time frame: Baseline, Week 4). The study lists 2 primary outcomes in all. 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 12 Aug 2026.