Acquired Immunodeficiency SyndromePhase 2NCT00032721
The Use of Reiki for Patients With Advanced AIDS
A Phase 2 study testing Reiki; Subtle energy therapy in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites in United States.
Trial summary
This study will investigate the use of Reiki, an energy-based complementary and alternative medicine (CAM) intervention, as an approach to improve well-being for patients with advanced AIDS, and evaluate its effects on dimensions of well-being and quality of life. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, HIV Infections
- What is being tested?
- Reiki; Subtle energy therapy
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2002to Sep 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of advanced AIDS, defined as: CD4 count of less than 200 during the past 12 months;
- On HAART for at least 6 months;
- Over age 18;
- Decisionally capable of providing informed consent.
Who cannot join
- Not capable of providing informed consent because of psychiatric limitations, e.g. active psychosis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Temple University
Philadelphia, Pennsylvania, 19121
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
This study will investigate the use of Reiki, an energy-based complementary and alternative medicine (CAM) intervention, as an approach to improve well-being for patients with advanced AIDS, and evaluate its effects on dimensions of well-being and quality of life.
Read the detailed description
This study will investigate the use of Reiki, an energy-based complementary and alternative medicine (CAM) intervention, as an approach to improve well being for patients with advanced AIDS, and evaluate its effects on dimensions of well being and quality of life. The study is a two-group comparison between participants receiving Reiki plus usual medical care (treatment) and participants receiving usual medical care only (control).
One hundred and forty-six patients with advanced AIDS will be enrolled and randomized into the two groups. Patients in the intervention (Reiki) group will receive a total of three one-hour Reiki sessions over a period of 6 weeks. Participants in both the intervention and control groups will be assessed at two times during the study period using repeated measures. We will investigate and compare changes in participants' anxiety, depression, pain, quality of life, and spiritual well being at the end of the intervention period. This is the first part of a longer-term research agenda to examine the use and effectiveness of complementary and alternative medicines for patients with advanced disease. We plan to examine one clinical context in which Reiki is currently provided. It is important to design studies that respect both the context of care and the practitioner-client relationship-elements essential to an understanding of the philosophy and delivery of CAM such as Reiki, and at the same time endeavor to outline a systematic approach to the study of CAM.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Being tested
- Reiki; Subtle energy therapy
- Keywords
- complementary therapies, Alternative medicine, Complementary and alternative medicine, Subtle energy therapy, Reiki, HIV/AIDS
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki; Subtle energy therapyProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2002 (estimated)
- Study startMar 2002
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 146 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Gala True, PhD, Principal investigator, Albert Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032721
- Sponsor's protocol ID
- R21AT001012-01
- Status last verified
- Jul 2006
- First submitted
- 29 Mar 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Reiki for Patients With Advanced AIDS
- ClinicalTrials.gov ID
- NCT00032721
- Acronym / sponsor ID
- R21AT001012-01
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections
- Keywords
- complementary therapies, Alternative medicine, Complementary and alternative medicine, Subtle energy therapy, Reiki, HIV/AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Mar 2002
- Study completion
- Sep 2003
- First posted
- 1 Apr 2002 (estimated)
- 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.
This study will investigate the use of Reiki, an energy-based complementary and alternative medicine (CAM) intervention, as an approach to improve well-being for patients with advanced AIDS, and evaluate its effects on dimensions of well-being and quality of life.
Detailed description
This study will investigate the use of Reiki, an energy-based complementary and alternative medicine (CAM) intervention, as an approach to improve well being for patients with advanced AIDS, and evaluate its effects on dimensions of well being and quality of life. The study is a two-group comparison between participants receiving Reiki plus usual medical care (treatment) and participants receiving usual medical care only (control).
One hundred and forty-six patients with advanced AIDS will be enrolled and randomized into the two groups. Patients in the intervention (Reiki) group will receive a total of three one-hour Reiki sessions over a period of 6 weeks. Participants in both the intervention and control groups will be assessed at two times during the study period using repeated measures. We will investigate and compare changes in participants' anxiety, depression, pain, quality of life, and spiritual well being at the end of the intervention period. This is the first part of a longer-term research agenda to examine the use and effectiveness of complementary and alternative medicines for patients with advanced disease. We plan to examine one clinical context in which Reiki is currently provided. It is important to design studies that respect both the context of care and the practitioner-client relationship-elements essential to an understanding of the philosophy and delivery of CAM such as Reiki, and at the same time endeavor to outline a systematic approach to the study of CAM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of advanced AIDS, defined as: CD4 count of less than 200 during the past 12 months;
- On HAART for at least 6 months;
- Over age 18;
- Decisionally capable of providing informed consent.
Key exclusion criteria (1 listed)
- Not capable of providing informed consent because of psychiatric limitations, e.g. active psychosis.
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 |
|---|---|---|
| Reiki; Subtle energy therapy | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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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.
Gala True, PhD principal investigator
Albert Einstein Healthcare Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Reiki; Subtle energy therapy in people with Acquired Immunodeficiency Syndrome and HIV Infections, run by National Center for Complementary and Integrative Health (NCCIH) at 2 sites 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 18 Aug 2006.