Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV

Not Applicable

Completed

• Conditions: HIV Infections; AIDS

• Registration Number: NCT00070980
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2003-03
• Study First Submitted: 2003-10-09
• Study First Submitted QC: 2003-10-10
• Study First Posted: 2003-10-13
• Study Completion: 2004-11
• Status Verified: 2006-07
• Last Update Submitted: 2006-08-17
• Last Update Posted: 2006-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Trial Locations

Locations (1)

CENISMI/Robert Reid Cabral Children's Hospital; 🇩🇴 Santo Domingo, Dominican Republic