The Use of Reiki for Patients With Advanced AIDS

HIV Infections Clinical Trial

Official title:

The Use of Reiki for Patients With Advanced AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032721
• Other study ID #: R21AT001012-01
• Status: Completed
• Phase: Phase 2
• First received: March 29, 2002
• Last updated: August 17, 2006
• Start date: March 2002
• Est. completion date: September 2003

Study information

• Verified date: July 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Procedure:
• Reiki; Subtle energy therapy

Locations

Country	Name	City	State
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,