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

Primary Purpose

HIV Infections, AIDS

Status
Completed
Phase
Not Applicable
Locations
Dominican Republic
Study Type
Interventional
Intervention
Massage therapy
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Complementary Therapies

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CENISMI/Robert Reid Cabral Children's Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 9, 2003
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00070980
Brief Title
Massage to Increase Well-Being and Immune Function in Dominican Children Infected With HIV
Official Title
Massage to Enhance Well-Being in HIV-Positive Dominican Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, AIDS
Keywords
Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
54 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Massage therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Shor-Posner, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
CENISMI/Robert Reid Cabral Children's Hospital
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Learn more about this trial

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

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