Relaxation Response With Acupuncture for HIV Patients

Human Immunodeficiency Virus Clinical Trial

Official title:

Relaxation Response With Acupuncture for HIV Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064740
• Other study ID #: R21AT001276-01A1
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2003
• Last updated: August 16, 2006
• Start date: July 2003
• Est. completion date: March 2006

Study information

• Verified date: August 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• AIDS
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Behavioral:
• relaxation response

Locations

Country	Name	City	State
United States	Aids Care Program	Boston	Massachusetts

Sponsors (1)

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

Country where clinical trial is conducted

United States,