Pilot Study of Pediatric Integrative Medicine in Pediatric Oncology, General Pediatrics and Pediatric Cardiology
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 872
- 试验地点
- 2
- 主要终点
- Enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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
排除标准
- •(i) cannot communicate in English;
- •(ii) lack of parent availability to participate; or
- •iii) lack of informed consent.
结局指标
主要结局
Enrollment
时间窗: up to 5 days
Enrollment of study participants over length of study which will inform conduct of a larger study in this population
次要结局
- 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)
- Length of hospital stay(up to 5 days)
研究者
Sunita Vohra
Professor
University of Alberta