Relaxation Response With Acupuncture for HIV Patients

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00064740
First received: July 11, 2003
Last updated: August 16, 2006
Last verified: August 2006

July 11, 2003
August 16, 2006
July 2003
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Complete list of historical versions of study NCT00064740 on ClinicalTrials.gov Archive Site
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Relaxation Response With Acupuncture for HIV Patients
Relaxation Response With Acupuncture for HIV Patients

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Human Immunodeficiency Virus
  • AIDS
Behavioral: relaxation response
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2006
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00064740
R21 AT001276-01A1
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Bei-Hung Chang, Sc.D Assistant Professor at Boston University School of Public Health
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP