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临床试验/NCT00310063
NCT00310063已完成不适用

Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2005年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
reduction of chemotherapy related nausea

研究概览

简要总结

RATIONALE: Using acupressure wrist bands to press and stimulate nerves at an acupressure point on the inside of the wrist may help control nausea and vomiting caused by chemotherapy.

PURPOSE: This randomized clinical trial is studying how well acupressure works in preventing nausea and vomiting in young cancer patients receiving chemotherapy.

详细描述

OBJECTIVES:

  • Determine the feasibility of implementing an acupressure therapy for the prevention of chemotherapy-associated nausea in children with cancer.
  • Test the hypothesis that acupressure bands will prevent chemotherapy-associated nausea and vomiting in children, when compared to placebo acupressure (wrist bands without acupressure).
  • Develop a competitive grant application for a large, multi-institutional randomized controlled trial of the efficacy of acupressure in preventing chemotherapy-associated nausea in children.

OUTLINE: This is a prospective, randomized, placebo-controlled, crossover, pilot study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients wear Sea-Band elastic acupressure wristbands on each wrist beginning approximately 1 hour before beginning their first inpatient chemotherapy session and continuing for at least 24 hours after completing chemotherapy. Patients do not wear wristbands for their second chemotherapy session. Patients wear placebo wristbands on each wrist beginning approximately 1 hour before their third chemotherapy session and continuing for at least 24 hours after completing chemotherapy.
  • Arm II: Patients wear placebo wristbands on each wrist beginning approximately 1 hour before their first chemotherapy session and continuing for at least 24 hours after completing chemotherapy. Patients do not wear wristbands for their second chemotherapy session. Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 1 hour before their third chemotherapy session and continuing for at least 24 hours after completing chemotherapy.

All patients also receive standard antiemetic therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
2 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm II

Sham Comparator

Sham wristband

干预措施: sham intervention (Procedure)

Arm I

Experimental

Sea Band elastic acupressure wristband

干预措施: acupressure therapy (Procedure)

结局指标

主要结局

reduction of chemotherapy related nausea

时间窗: 6 months

assessment by questionaire of nausea during patient chemo

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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