- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00032721
The Use of Reiki for Patients With Advanced AIDS
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19141
- Albert Einstein Medical Center
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Philadelphia, Pennsylvania, United States, 19121
- Temple University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- 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.
Exclusion Criteria:
- Not capable of providing informed consent because of psychiatric limitations, e.g. active psychosis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Collaborators and Investigators
Investigators
- Principal Investigator: Gala True, PhD, Albert Einstein Healthcare Network
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- R21AT001012-01 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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