Pediatric Integrative Medicine Trial Pilot

Pain Clinical Trial

— PIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02028832
• Other study ID #: PIM1
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2013
• Last updated: May 3, 2017
• Start date: February 2013
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 872
• Est. completion date: September 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Nausea
• Pain
• Vomiting

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	Stollery Childrens' Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Lotte & John Hecht Memorial Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resource Utilization/Cost	Resource utilization and related costs will be compared between study arms	Analysis of this outcome to be limited to patients admitted for at least 2 days and for not more than 30 days
Primary	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	Change in pain	For pre-verbal children: Faces, Legs, Activity, Cry, Consolability tool Verbal children: faces Pain Scale-Revised	up to 5 days
Secondary	Change in nausea/vomiting	Baxter Retching Faces scale	up to 5 days
Secondary	Change in anxiety	Pediatrics Anxiety Faces scale	up to 5 days
Secondary	Incidence of adverse events	BC Children's Hospital Patient Safety Questionnaire; Canadian Pediatric Trigger tool	up to 5 days
Secondary	Parent satisfaction with patient care	Hospital's standardized satisfaction survey; State-Trait Anxiety Invenvtory	up to 5 days
Secondary	Length of hospital stay		up to 5 days