Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
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Purpose
The purpose of this study is to determine whether massage therapy can improve immune status and enhance well-being in children living in the Dominican Republic who are infected with HIV.
| Condition | Intervention |
|---|---|
|
HIV Infections AIDS |
Procedure: Massage therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Massage to Enhance Well-Being in HIV-Positive Dominican Children |
| Estimated Enrollment: | 54 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | November 2004 |
The incidence of pediatric HIV in the Dominican Republic has been rapidly rising, while antiretroviral therapies are not yet readily available to slow disease progression. There is compelling evidence that massage therapy may enhance immune status and alter the course of HIV disease. Increased immune capacity and improvement in HIV disease progression markers have been demonstrated following massage therapy in HIV infected adolescents and adults, even in the absence of antiretroviral treatments. In studies with premature newborns, increased weight gain, decreased stress behavior, and more optimal cognitive and motor development have been reported following massage treatment. This study will examine the efficacy of massage therapy, an affordable and potentially beneficial complementary/alternative treatment, to promote health and enhance well-being in HIV infected children in the Dominican Republic.
Children will be randomly assigned to receive either massage therapy or standard care/friendly visits twice weekly for 12 weeks. Data will be gathered to assess acceptance, safety, and compliance to massage therapy and to examine whether massage treatment has improved immune function, developmental performance, and behavioral function.
Eligibility| Ages Eligible for Study: | 3 Years to 7 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV infection
- Parent/caregiver signature on consent form
Exclusion criteria:
- Unknown HIV status
- Fever, new opportunistic infection, or acute hospitalization within 30 days prior to study entry
- Massage therapy within 30 days prior to study entry
- Unable to have massage (e.g., extensive skin lesions)
- Symptoms of child abuse
- Child born drug-addicted
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00070980 History of Changes |
| Other Study ID Numbers: | R21 AT001160-01A1 |
| Study First Received: | October 9, 2003 |
| Last Updated: | August 17, 2006 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Complementary Therapies |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on May 22, 2013