Pediatric Integrative Medicine Trial Pilot (PIM)

University of Alberta

Status and phase: Completed; Phase 3

Conditions: Vomiting; Nausea; Anxiety; Pain

Treatments: Procedure: PIM consult and service provision; Procedure: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02028832

PIM1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 872 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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872 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Usual care provided to pediatric inpatients

Treatment:

Procedure: Usual care

PIM consult and service provision

Experimental group

Description:

Pediatric integrative medicine service (PIM) through which pediatric inpatients will have the option of supplementing their usual care with acupuncture/acupressure, massage, and/or reiki

Treatment:

Procedure: Usual care

Procedure: PIM consult and service provision