Pain Clinical Trial
Official title:
Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology, General Pediatrics and Pediatric Cardiology
This study will investigate if adding complementary therapies such as acupuncture, massage and reiki to inpatient pediatric care is feasible and what the effects are on outcomes such as patient symptoms, cost, safety, satisfaction and length of stay.
Study Objective: To determine if a pediatric integrative medicine (PIM) service is effective
in reducing overall symptoms of pain, nausea/vomiting, and/or anxiety (PNVA), length of
stay, and costs, in hospitalized children when compared to conventional care. In this
context, "integrative" refers to a combined approach of complementary and conventional
medical therapies in an evidence-based fashion.
Design: cluster trial; 2-arm controlled evaluation study in pediatric oncology, general
pediatrics and pediatric cardiology. Intervention will be offered during a 6-month PIM
period following a 6 month control period.
Population: Inclusion criteria: (i) In-patients in participating division and (ii) informed
consent/assent. Exclusion criteria: (i) lack of parent participation, fluency in English, or
informed consent
Intervention: Recommendations for specific CAM therapies will be determined by a staff PIM
pediatrician. Any combination of the following CAM therapies (dose, duration, amount to be
based on patient need as assessed by CAM provider, patient, and parent):
acupuncture/acupressure, massage, Reiki; all are to be offered in addition to usual care.
Control: Usual care.
Outcomes: Primary outcome: feasibility (i.e enrollment); Secondary outcomes: (i) PNVA
symptom management, (ii) need for conventional pharmacotherapy, (iii) adverse events; (iv)
parent and health care provider satisfaction with care provided, v) length of stay; and vi)
cost-effectiveness (analysis of this outcome to be limited to patients admitted for at least
2 days and for not more than 30 days).
Significance: To our knowledge, this study will be the first comparative effectiveness trial
to assess the impact of PIM for hospitalized children with cancer.
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