Pediatric Integrative Medicine Trial Pilot
PIM
Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology, General Pediatrics and Pediatric Cardiology
1 other identifier
interventional
872
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Feb 2013
Longer than P75 for phase_3 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 16, 2013
CompletedFirst Posted
Study publicly available on registry
January 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedMay 8, 2017
May 1, 2017
3 years
December 16, 2013
May 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Change in pain
up to 5 days
Change in nausea/vomiting
up to 5 days
Change in anxiety
up to 5 days
Incidence of adverse events
up to 5 days
Parent satisfaction with patient care
up to 5 days
- +1 more secondary outcomes
Other Outcomes (1)
Resource Utilization/Cost
Analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days
Study Arms (2)
Usual care
ACTIVE COMPARATORUsual care provided to pediatric inpatients
PIM consult and service provision
EXPERIMENTALPediatric integrative medicine service (PIM) through which pediatric inpatients will have the option of supplementing their usual care with acupuncture/acupressure, massage, and/or reiki
Interventions
If service is requested, treatment options include acupuncture/acupressure, massage, and reiki
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
Eligibility Criteria
You may qualify if:
- (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
You may not qualify if:
- (i) cannot communicate in English;
- (ii) lack of parent availability to participate; or
- iii) lack of informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Lotte & John Hecht Memorial Foundationcollaborator
Study Sites (1)
Stollery Childrens' Hospital
Edmonton, Alberta, T6G 2B7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunita Vohra, MD, MSc
University of Alberta
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 16, 2013
First Posted
January 7, 2014
Study Start
February 1, 2013
Primary Completion
February 1, 2016
Study Completion
September 1, 2016
Last Updated
May 8, 2017
Record last verified: 2017-05