Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lotte & John Hecht Memorial Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | Active Comparator | Usual care provided to pediatric inpatients |
|
| PIM consult and service provision | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PIM consult and service provision | Procedure | If service is requested, treatment options include acupuncture/acupressure, massage, and reiki |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sunita Vohra, MD, MSc | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stollery Childrens' Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D009325 | Nausea |
| D014839 | Vomiting |
| D001008 | Anxiety Disorders |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual care | Procedure | Usual care consists of all conventional care options in pediatric oncology including medication and other therapies. |
|
| 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 |
| D001523 | Mental Disorders |