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临床试验/NCT00754286
NCT00754286已完成不适用

A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer

Albert Einstein College of Medicine2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2008年7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
132
试验地点
2
主要终点
Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.

研究概览

简要总结

Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. Therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.

详细描述

Nausea and vomiting remain two of the most distressing symptoms to children being treated for cancer. Nausea and vomiting are directly associated with the administration of chemotherapy, due to effects of the chemotherapy on the gastrointestinal mucosa, and certain chemotherapeutic agents, such as cisplatin, are known to be particularly emetogenic. In addition, anticipatory anxiety has been identified as an important patient factor in the development of post-chemotherapy nausea and vomiting. Many drugs have been developed in an effort to diminish nausea and vomiting in children receiving emetogenic chemotherapy and these agents, particularly the 5-hydroxytryptamine receptors, have vastly reduced the amount of nausea and vomiting experienced in this population. However, approximately 50% of children and adolescents still suffer from nausea and/or vomiting even after maximal pharmacological intervention. This suggests that other interventions are needed to further reduce the experienced nausea and vomiting seen in children undergoing chemotherapy. As such, many patients and providers have turned to complementary and alternative medicine (CAM) for the relief of nausea and vomiting. Aromatherapy is one such modality that has demonstrated some degree of effectiveness in adults suffering from nausea and vomiting due to chemotherapy, motion sickness, or postoperatively.

Aromatherapy is an inexpensive and easy therapy to administer to children, and many children can self administer aromatherapy depending on their age and the form of aromatherapy. Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. Therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.

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
Triple (Participant, Care Provider, Investigator)

入排标准

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

入选标准

  • Patients aged 7-21 with a diagnosis of cancer and will be receiving emetogenic chemotherapy.

排除标准

  • Patients allergic to peppermint, ginger or lavender

研究组 & 干预措施

Aromatherapy

Experimental

Participants will be given aromatherapy wand at the onset of their chemotherapy treatment.

干预措施: Aromatherapy Scented Wand (Other)

Placebo

Placebo Comparator

Participants will be given the placebo wand at the onset of their chemotherapy treatment. Placebo wands will look identical to the scented wands but will not contain a scent.

干预措施: Placebo wand (Other)

结局指标

主要结局

Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.

时间窗: One week after completed chemotherapy

次要结局

  • Effects on anxiety, depression and quality of life in this population(At beginning and at end of chemotherapy cycle)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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