Pediatric Integrative Medicine Trial Pilot

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology, General Pediatrics and Pediatric Cardiology

Conditions
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Pain, Nausea, Vomiting, Anxiety

Intervention / Treatment
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* Procedure: PIM consult and service provision
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Usual care provided to pediatric inpatients | Procedure: Usual care<br>* Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.<br>|
| Experimental: PIM consult and service provision<br>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 | Procedure: PIM consult and service provision<br>* If service is requested, treatment options include acupuncture/acupressure, massage, and reiki<br>Procedure: Usual care<br>* Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment | Enrollment of study participants over length of study which will inform conduct of a larger study in this population | up to 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | For pre-verbal children: Faces, Legs, Activity, Cry, Consolability tool Verbal children: faces Pain Scale-Revised | up to 5 days | 
| Change in nausea/vomiting | Baxter Retching Faces scale | up to 5 days | 
| Change in anxiety | Pediatrics Anxiety Faces scale | up to 5 days | 
| Incidence of adverse events | BC Children's Hospital Patient Safety Questionnaire; Canadian Pediatric Trigger tool | up to 5 days | 
| Parent satisfaction with patient care | Hospital's standardized satisfaction survey; State-Trait Anxiety Invenvtory | up to 5 days | 
| Length of hospital stay |  | up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, nausea/vomiting, anxiety, complementary and alternative medicine, pediatric, oncology, cost-effectiveness