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临床试验/NCT03130218
NCT03130218已完成不适用

Aromatherapy in Management of Postoperative Nausea in Post-Bariatric Surgery Patients

Lancaster General Hospital2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2017年6月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
204
试验地点
2
主要终点
Count of Antiemetic Drug Therapies

研究概览

简要总结

Determine the effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population.

详细描述

Healthy weight management and use of essential oils and aromatherapy as natural interventions to manage health-related issues are significantly growing interests. One frequent intervention for healthy weight management is bariatric surgery. In the post-operative period following bariatric surgery, nausea is a common consequence. Peppermint oil aromatherapy is an effective intervention for relieving nausea and other gastrointestinal symptoms in the bariatric and surgical population. This study has multiple aims. One is to determine effectiveness of peppermint oil aromatherapy in relieving post-operative nausea in the bariatric surgery patient population. A second aim is to establish relative cost-effectiveness of peppermint oil aromatherapy versus traditional anti-emetic drug therapies. A third is to determine whether peppermint oil aromatherapy increases patient satisfaction versus anti-emetic drug therapies. This is a randomized study with control and experimental groups. The control group will receive no peppermint oil aromatherapy and only traditional anti-emetics as needed. The experimental group will receive peppermint oil aromatherapy and traditional anti-emetics as needed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Bariatric surgery candidate on 7-Lime at Lancaster General Hospital
  • Scheduled for laparoscopic sleeve gastrectomy and laparoscopic Roux-En-Y (RNY) procedures
  • Between ages of 18 and 70
  • Surgical patient of either Dr. James Ku and Dr. Joseph McPhee

排除标准

  • History of excessive sensitivity to peppermint oil, allergic response to peppermint oil and who state preference against aromatherapy
  • Not alert and oriented or unable to follow directions will be excluded
  • Severe reactive airway disease such as asthma or chronic obstructive pulmonary disease (COPD)
  • Possible exclusion for severe hypertension or atrial fibrillation

结局指标

主要结局

Count of Antiemetic Drug Therapies

时间窗: 4 Hours

Number of antiemetic drug therapies used in the post-operative period

Perception of Postoperative Nausea Management Survey

时间窗: 24 Hours

Patient satisfaction with effectiveness of postoperative nausea management

Nausea Assessment and Treatment Scale

时间窗: 4 Hours

Severity of post-operative nausea on a scale of 0-10

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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