Human Immunodeficiency VirusPhase 2NCT00064740
Relaxation Response With Acupuncture for HIV Patients
A Phase 2 study testing relaxation response in people with Human Immunodeficiency Virus and AIDS, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, AIDS
- What is being tested?
- relaxation response
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Mar 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Human Immunodeficiency Virus, AIDS
- Being tested
- relaxation response
- Keywords
- Human Immunodeficiency Viruses, Relaxation, Acupuncture, Complementary therapies
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation responseBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2003 (estimated)
- Study startJul 2003
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Bei-Hung Chang, Sc.D, Principal investigator, Assistant Professor at Boston University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00064740
- Sponsor's protocol ID
- R21AT001276-01A1
- Status last verified
- Aug 2006
- First submitted
- 11 Jul 2003
- Last updated
- 18 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation Response With Acupuncture for HIV Patients
- ClinicalTrials.gov ID
- NCT00064740
- Acronym / sponsor ID
- R21AT001276-01A1
- Conditions
- Human Immunodeficiency Virus, AIDS
- Keywords
- Human Immunodeficiency Viruses, Relaxation, Acupuncture, Complementary therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Jul 2003
- Study completion
- Mar 2006
- First posted
- 14 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxation response | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bei-Hung Chang, Sc.D principal investigator
Assistant Professor at Boston University School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing relaxation response in people with Human Immunodeficiency Virus and AIDS, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006; AzTrials last refreshed its copy on 6 Nov 2026.