The Use of Reiki for Patients With Advanced AIDS
Primary Purpose
Acquired Immunodeficiency Syndrome, HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reiki; Subtle energy therapy
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Immunodeficiency Syndrome focused on measuring complementary therapies, Alternative medicine, Complementary and alternative medicine, Subtle energy therapy, Reiki, HIV/AIDS
Eligibility Criteria
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.
Sites / Locations
- Temple University
- Albert Einstein Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00032721
First Posted
March 29, 2002
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00032721
Brief Title
The Use of Reiki for Patients With Advanced AIDS
Official Title
The Use of Reiki for Patients With Advanced AIDS
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immunodeficiency Syndrome, HIV Infections
Keywords
complementary therapies, Alternative medicine, Complementary and alternative medicine, Subtle energy therapy, Reiki, HIV/AIDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Reiki; Subtle energy therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gala True, PhD
Organizational Affiliation
Albert Einstein Healthcare Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19121
Country
United States
Facility Name
Albert Einstein Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
12. IPD Sharing Statement
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The Use of Reiki for Patients With Advanced AIDS
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