Overview

This trial is active, not recruiting.

Conditions pain, nausea, vomiting, anxiety
Treatments pim consult and service provision, usual care
Phase phase 3
Sponsor University of Alberta
Collaborator Lotte & John Hecht Memorial Foundation
Start date February 2013
End date February 2016
Trial size 200 participants
Trial identifier NCT02028832, PIM1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
Usual care provided to pediatric inpatients
usual care
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
(Experimental)
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
pim consult and service provision
If service is requested, treatment options include acupuncture/acupressure, massage, and reiki
usual care
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.

Primary Outcomes

Measure
Enrollment
time frame: up to 5 days

Secondary Outcomes

Measure
Change in pain
time frame: up to 5 days
Change in nausea/vomiting
time frame: up to 5 days
Change in anxiety
time frame: up to 5 days
Incidence of adverse events
time frame: up to 5 days
Parent satisfaction with patient care
time frame: up to 5 days
Length of hospital stay
time frame: up to 5 days
Change in other clinical symptoms
time frame: up to 5 days

Eligibility Criteria

Male or female participants up to 16 years old.

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.

Additional Information

Official title Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology, General Pediatrics and Pediatric Cardiology
Principal investigator Sunita Vohra, MD, MSc
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Alberta.