Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064740
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2003-07-11
Brief Title:
Relaxation Response With Acupuncture for HIV Patients
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Relaxation Response With Acupuncture for HIV Patients
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Advances in treatment has turned HIVAIDS 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:
HIVAIDS 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 HIVAIDS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None