Pediatric Integrative Medicine Trial Pilot

Phase 3

Completed

• Conditions: Pain; Anxiety; Vomiting; Nausea

• Registration Number: NCT02028832
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-12-16
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-07
• Primary Completion: 2016-02
• Study Completion: 2016-09
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 872

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Enrollment	up to 5 days	Enrollment of study participants over length of study which will inform conduct of a larger study in this population

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Stollery Childrens' Hospital; 🇨🇦 Edmonton, Alberta, Canada