Massage |
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Clinical Trial: Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
This study is currently recruiting patients.
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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 | Treatment or Intervention |
|---|---|
| HIV Infections AIDS | Procedure: Massage therapy |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study
Official Title: Massage to Enhance Well-Being in HIV-positive Dominican Children
Expected Total Enrollment: 54
Study start: March 2003; Expected completion: 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 - 7 Years, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Dominican Republic
CENISMI/Robert Reid Cabral Children's Hospital, Santo Domingo, Dominican Republic; Recruiting
Gail Shor-Posner, MD, Principal Investigator, University of Miami
More Information
Record last reviewed: November 2004
Last Updated: November 9, 2004
Record first received: October 9, 2003
ClinicalTrials.gov Identifier: NCT00070980
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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