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Relaxation Response With Acupuncture for HIV Patients

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

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Descriptive Information Fields
Brief Title  Relaxation Response With Acupuncture for HIV Patients
Official Title  Relaxation Response With Acupuncture for HIV Patients
Brief Summary

Advances in treatment has turned HIV/AIDS into a chronic illness. Relaxation response is a state in which individuals evoke a bodily calm, effecting physiological changes that are shown to be associated with improved immune functioning. Acupuncture and relaxation are thought to both induce calm and deep relaxation in mind and body. This trial will study the combined effects of acupuncture and relaxation response in HIV patients.

Detailed Description

HIV/AIDS patients experience a range of symptoms associated with clinical manifestations of the disease, opportunistic infections, and medication side effects, all of which are strongly associated with quality of life (QoL). Many HIV/AIDS patients use complementary and alternative medicine (CAM) to help alleviate their symptoms and to improve their QoL. Among the various CAMs, acupuncture and relaxation response are commonly used regimens. These two therapies are thought to share common features and can complement each other in that acupuncture facilitates the effect of relaxation response and on the other hand relaxation response prepares the body to be more accessible to acupuncture. This study will test the feasibility of conducting a double blind 2-arm controlled trial and to collect pilot data in preparation for a large-scale study to fully test the hypothesis that adding relaxation response to acupuncture will have an enhanced effect in HIV+ patients. For this pilot study, we will recruit 100 HIV+ patients who are currently receiving acupuncture. Study participants in the intervention group will listen to tapes with instructions to elicit the relaxation response as well as music routinely played while receiving acupuncture. Study participants in the control group will receive usual care that is listening to music while receiving acupuncture. Study participants in the intervention group will be given the relaxation response tapes for home practice and they are asked to record the frequency of usage. We will assess both groups' symptoms and quality of life at baseline, 4 weeks, 8 weeks, and upon completion of the intervention at 12 weeks. We will assess the feasibility using various indicators, including patient evaluation of the study. Ultimately, the qualitative analysis of patients' study evaluation as well as the longitudinal regression analysis results that compare the outcomes between the intervention and control groups will be used to help design a future large-scale study of the relaxation response intervention among HIV+ patients treated with acupuncture.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Human Immunodeficiency Virus
AIDS
Intervention  Behavioral: relaxation response
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  100
Start Date  July 2003
Completion Date March 2006
Eligibility Criteria 

Inclusion Criteria:

  • HIV positive
  • First time and long-term acupuncture users
  • Symptomatic criteria including: sinus problem, headache, dental pain/sore or bleeding gums, nausea, diarrhea, vomiting, muscle aches, joint pain, neuropathy, weakness, anxiety, depression, and insomnia

Exclusion Criteria:

  • Patients suffering from acute symptoms
  • Patients with acute opportunistic infections
  • Patients currently practicing relaxation response
  • Patients currently enrolled in another intervention study
  • Cognitive impairment as measured by MMSE (Mini Mental Status Examination)
  • Lack of English proficiency
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00064740
Organization ID R21 AT001276-01A1
Secondary IDs ††
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators ††
Investigators 
Principal Investigator:     Bei-Hung Chang, Sc.D     Assistant Professor at Boston University School of Public Health    
Information Provided By National Center for Complementary and Alternative Medicine (NCCAM)
Verification Date August 2006
First Received Date  July 11, 2003
Last Updated Date August 16, 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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