Massage for Children Undergoing Bone Marrow Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)
研究概览
简要总结
Undergoing bone marrow transplantation (BMT) is associated with a high level of distress for patients and caregivers. Clinical research studies have reported benefits from massage for a) oncology patients, b) children, c) adults and children undergoing bone marrow transplants. A multi-center study of an intervention using a combination of massage therapy and a laugh cart to reduce distress in pediatric oncology patients undergoing BMT (PI: Phipps) is completed with results not yet published. There is still a need for independent studies to isolate the effect of massage for clinical outcomes (such as improved nausea and pain control) in children. Furthermore, this study will test the acceptability of an augmented massage intervention. In addition to provider-child massage, the augmented massage intervention includes training of the resident parent to provide additional parent-child massage, to relieve symptoms as needed. The goal of this augmented intervention is the improvement of symptom management in patients and decreased stress and feelings of helplessness in parents.
We propose a randomized pilot study at the UCSF pediatric bone marrow transplant center to assess the feasibility of a higher-quality study of the effects of massage in this population.
Aim 1: Determine the acceptability of a massage intervention for patients and parents on a pediatric bone marrow transplant unit.
Aim 2: Explore the logistics of implementing the augmented massage intervention at the bedside offered to consecutive patients over one year's time.
Aim 3: Collect preliminary data for patients and parents including patient clinical outcomes, quality of life, and satisfaction, and parental stress and mood to allow sample size calculations for further studies.
详细描述
This study is a pilot randomized controlled feasibility trial of an augmented massage intervention, compared to a usual-care control group, in which intervention group participants will receive up to 3 massage sessions per week, during the 4-6 hospitalization at UCSF for Bone Marrow Transplant (BMT).
Participants will be approximately 24 children recruited from consecutive sample of pediatric cancer and non-cancer patients undergoing BMT age 5 to 18 admitted to UCSF children's hospital during one calendar year.
Intervention: Massage sessions will be gentle Swedish style combine with acupressure and will range from 20-45 minutes, provided by credentialed and trained massage therapists; augmentation will involve massage training for the resident parent, who rooms with the patient, to administer massage to his/her child during the course of the hospital stay. The control group will receive standard-care.
We will collect feasibility data and do exploratory comparison of clinical outcomes between groups.
Knowledge to be gained: We will have preliminary data for a larger trial that will determine whether an augmented massage intervention can support symptom management in the pediatric BMT unit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being 5 to 18 years old
- •Admitted for BMT.
- •Rationale: This is a pediatric study for children up to age 18 admitted to the BMT unit. Questionnaires are not designed for children under age 5.
排除标准
- •Parent or child unable to answer questionnaire due to language limitations.
- •Rationale: The pilot character of the study with its limited budget does not include instruments in foreign languages, such as Chinese or Spanish. This could be a project for further studies.
结局指标
主要结局
Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable)
时间窗: 7 days pre to 21 days post transplant = 28 days
days of pain \>3 by nurses notes based on pain scores on numeric rating scale (up to 28 days)
次要结局
- Number of Vomiting Episodes(day -7 to +21 around transplant date)
- Days of Hospital Stay(days of hospital stay after bone marrow transplant)
- Days to Recovery Neutrophil Count(hospital stay)