Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in total sleep minutes
研究概览
简要总结
This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).
详细描述
Hospitalized pediatric oncology patients report anxiety, pain, disturbed sleep, and excess fatigue. Massage is safe, does not interfere with medications, and has been shown in limited studies to have efficacy in improving sleep as well as decreasing fatigue, anxiety and other symptoms in cancer patients and children with various ailments.
This project aims to determine if individualized massage therapy for hospitalized pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT) is associated with longer duration and improved quality of sleep, more robust circadian rhythms (CARs), improved quality of life (QOL) and reduced fatigue, anxiety, and pain, as compared to a standard of care group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication
- •Expected to be an inpatient for at least 21 days
- •Aged 12 to 21 years at enrollment.
- •Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).
排除标准
- •Cognitive impairment sufficient to preclude completing questionnaires appropriately
- •Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
- •Previous enrollment
研究组 & 干预措施
Control Arm (CA)
Standard of care.
干预措施: Standard of care (Other)
Intervention Arm (IA)
Massage therapy
干预措施: Massage therapy (Other)
结局指标
主要结局
Change in total sleep minutes
时间窗: 3 weeks
Change in the total number of sleep minutes over time in the standard of care intervention compared to the change in the total number of sleep minutes over time in the massage therapy intervention. Sleep minutes are measured by actigraphy.
次要结局
- Change in sleep quality as demonstrated by circadian activity rhythms (CARs)(3 weeks)