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

This study has been completed.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: October 9, 2003
Last updated: August 17, 2006
Last verified: July 2006
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
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Massage to Enhance Well-Being in HIV-Positive Dominican Children

Resource links provided by NLM:

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Estimated Enrollment: 54
Study Start Date: March 2003
Estimated Study Completion Date: November 2004
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.


Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
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
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Please refer to this study by its identifier: NCT00070980

Dominican Republic
CENISMI/Robert Reid Cabral Children's Hospital
Santo Domingo, Dominican Republic
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Gail Shor-Posner, MD University of Miami
  More Information Identifier: NCT00070980     History of Changes
Other Study ID Numbers: R21AT001160-01A1 ( U.S. NIH Grant/Contract )
Study First Received: October 9, 2003
Last Updated: August 17, 2006

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases processed this record on September 20, 2017