Anxiety, Nausea, Pain, Vomiting
Conditions
Keywords
pain, nausea/vomiting, anxiety, complementary and alternative medicine, pediatric, oncology, cost-effectiveness
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.
Interventions
PROCEDUREPIM consult and service provision
If service is requested, treatment options include acupuncture/acupressure, massage, and reiki
PROCEDUREUsual care
Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
Sponsors
Lotte & John Hecht Memorial Foundation
University of Alberta
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 | — |
| Incidence of adverse events | up to 5 days | BC Children's Hospital Patient Safety Questionnaire; Canadian Pediatric Trigger tool |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | Resource utilization and related costs will be compared between study arms |
Countries
Canada
Outcome results
None listed