Clinical trial NCT02028832: Pediatric Integrative Medicine Trial Pilot
Official title: Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology, General Pediatrics and Pediatric Cardiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Nausea
Vomiting
Anxiety
Keywords: pain
nausea/vomiting
anxiety
complementary and alternative medicine
pediatric
oncology
cost-effectiveness
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Lotte & John Hecht Memorial Foundation
First posted: 2014-01-07
Enrollment: 872
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* (i) all children, aged 0-16 years, who are admitted to Pediatric Oncology, General Pediatrics and Pediatric Cardiology at the Stollery Children's Hospital, Edmonton, Canada who
* (ii) can communicate in English; and
* (iii) give informed consent/assent

Exclusion Criteria:

* (i) cannot communicate in English;
* (ii) lack of parent availability to participate; or
* iii) lack of informed consent.

Primary outcomes:
measure: Enrollment
timeFrame: up to 5 days
Secondary outcomes:
measure: Change in pain
timeFrame: up to 5 days
measure: Change in nausea/vomiting
timeFrame: up to 5 days
measure: Change in anxiety
timeFrame: up to 5 days
measure: Incidence of adverse events
timeFrame: up to 5 days
measure: Parent satisfaction with patient care
timeFrame: up to 5 days
measure: Length of hospital stay
timeFrame: up to 5 days
Other outcomes:
measure: Resource Utilization/Cost
timeFrame: Analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days
Locations:
city: Edmonton
country: Canada
facility: Stollery Childrens' Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Sunita Vohra, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: