Inhalation Aromatherapy on Nausea, Vomiting and Anxiety During Autologous Hematopoietic Stem Cell Transplantation: An Open-label Randmized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 主要终点
- Change in nausea severity
研究概览
简要总结
Patients undergoing stem cell transplantation for the first time will be entered. Participants will be randomized to one of two study arms: Arm 1: intervention (routine care+ inhalation aromatherapy); Arm 2: Control (Routine care) Hypotheses: (1) Patients receiving inhalation aromatherapy will experience less severe nausea and less frequent vomiting episodes than those receiving only routine care; and (2) patients receiving inhalation aromatherapy will demonstrate lower anxiety levels just after AHSCT than those receiving only routine care.
详细描述
Earlier research indicates that aromatherapy is promising to relieve in DMSO related nausea and anxiety in autologous stem cell transplant patients. The current study seeks to confirm and extend these findings in a 2-arm, open-label randomized, controlled study of 70 cancer patients undergoing autologous stem cell transplantation. All patients will receive a standardized premedication. Arm 1: Intervention (inhalation aromatherapy with orange essential oil during stem cell infusion); Arm 2: Control (routine care). The researchers hypothesize that inhalation aromatherapy with orange essential oil will be effective in reducing DMSO related nausea and vomiting and demonstrate lower anxiety levels just after autologous stem cell transplantation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age > 18 years,
- •the absence of any mental conditions including depression, anxiety disorders, psychotic disorders or dementia that may affect the patients' communication abilities
排除标准
- •Patients with chronic obstructive pulmonary disease or asthma,
- •a history of allergy to orange or orange essential oil,
- •presence of persistent nausea and vomiting due to conditioning regimens,
- •receiving antiemetic other than routine premedication,
- •patients undergoing AHSCT for the second or more time were excluded
结局指标
主要结局
Change in nausea severity
时间窗: At 1st minute of each stem cell infusion bag
Patient report Nausea severity will be assessed based on patient report by using a visual analog scale. The patients will be asked to rate their nausea severity and place a mark on the scale from 0 to 10.
change in number of vomiting
时间窗: From 1st minute of the stem cell infusion to completion of the intervention
Observation Number of vomiting and retching episodes will be observed by the researcher who apply aromatherapy and recorded in a vomiting and retching episodes form.
次要结局
- anxiety(Through stem cell infusion completion, an avarege of 30 minutes)
研究者
Nur Izgu
Assoc. Prof., RN, PhD
Hacettepe University