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临床试验/NCT03093454
NCT03093454已完成3 期

Effects of Lavender Oil on Postoperative Pain, Sleep Quality and Mood

Scott Hollenbeck, MD1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2017年10月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
58
试验地点
1
主要终点
Effects of Lavender Oil on Postoperative Pain Through Pain Scores

研究概览

简要总结

This project will evaluate the integration of lavender essential oil in surgical patients during the perioperative and postoperative phase of care. The study will assess patients' pain, sleep quality, and mood. The goal is to support that lavender oil will decrease pain scores and narcotic use, increase sleep quality, and decrease anxiety by improving overall patient satisfaction and supporting their natural sense of well being. This research project will help support the use of complementary medicine in a hospital setting. The increased awareness and use of complementary medicine in a hospital setting will strengthen the patient centered care model that all hospitals strive to achieve.

详细描述

Background & Significance:

Essential oils have been formally documented in use since the time of the Egyptians. The Ebers Papyrus document notes Egyptians using frankincense for different physical ailments. In Greece Hippocrates used essential oils to fumigate the city of Athens to fight off the plague. In medieval periods lavender essential oil was used for its antidepressive, anxiolytic, sedative, and analgesic properties. Medieval Persian physicians made records of their treatment plans which included lavender for depression and pain for headaches. With the invention of steam distillation to separate the essential oil from the plant Europe began to use oils in perfumes and for medicinal benefits in the 1500's. Two physicians named Hieronymus and Brunschwig wrote one of the earliest printed books on the distillation and use of essential oils for medical benefits. By the 19th century a French chemist Rene- Maurice Gattefosse was known for studying essential oils and their therapeutic benefits. His work and documentation led the way for the support of essential oil in medical ailments. Robert Tisserand in the early 1990s reviewed the French chemists work and added to his research to help make essential oils more known to the public in present day.

In recent years lavender has been studied on human subjects to tests its known reputation for sedative, anxiolytic, and analgesic properties. In one clinical trial oral administration of lavender was compared to Ativan 0.5mg for generalized anxiety disorder. The study supported that the oral lavender oil called Silexan was as effective as 0.5mg of Ativan in adults with generalized anxiety disorder. A second clinical trial analyzing sleep quality found that ischemic heart patients in the intensive care unit received better sleep with 100% lavender oil undiluted placed on a cotton ball within 20cm from the patient from the hours of 9pm-6am. Two studies have used lavender oil through inhalation in the recovery room with an oxygen mask after surgery for pain control. The first study was patients after breast biopsy, the second was patients who just had laparoscopic adjustable gastric banding. The study with the breast biopsy patients showed a higher satisfaction rate with pain. The patients undergoing laparoscopic banding also showed a higher rate of satisfaction with pain as well as decreased opioid use in the recovery room. Furthermore one study used 100% lavender oil undiluted on the skin of pediatric patients undergoing tonsillectomy as a topical application and asked the patients to inhale. The study showed a decrease use in Tylenol usage postoperatively.

Design & Procedures:

Design Randomized study with control group and test group. Using a 1:1 treatment allocation ratio, the total of 60 patients (30 per arm) will be randomly assigned to control or treatment arm. The Statistical Investigator will generate the randomization scheme and monitor the randomization process over the course of the trial. The study will use randomization with random permuted blocks. The test group will receive 50% lavender oil diluted in fractionated coconut oil and the control group will have the current standard of care with no essential oil intervention. Fractionated coconut oil is being used because it is colorless, odorless, does not stain clothing, and has a long shelf life. It also serves as a carrier oil for the essential oil to absorb into the skin instead of evaporating off the skin due to essential oils volatile nature.

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 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women undergoing any form of breast reconstruction therapy
  • Ages 18-85
  • At least a one night stay in hospital after surgery

排除标准

  • Use of sleeping aide drugs
  • Use of benzodiazepines
  • History of any of the following: asthma, eczema, allergy to flowers, smell disorders
  • Sensitivity to lavender oil or any of its ingredients
  • Pregnant women will be excluded from the study. During routine preoperative testing the patient's menstrual history or urine pregnancy test will be performed to identify any patient who is pregnant.

研究组 & 干预措施

Lavender Group

Experimental

Patient will receive lavender essential oil topically and by inhalation during their hospital stay while at the same time receiving regular standard of care.

干预措施: Lavender Essential Oil (Drug)

结局指标

主要结局

Effects of Lavender Oil on Postoperative Pain Through Pain Scores

时间窗: Pre-operatively, Post-op Day 1 (POD1), and final post-op day (final POD)

Assess pain through pain scores documented in medical record compared to control group. Pain score of 0 is no pain versus pain score of 10 is highest pain possible.

Effects of Lavender Oil on Sleep

时间窗: Pre-operatively, Post-op Day 1(POD1), and final Post-op Day (final POD)

Assess sleep quality by Richards Campbell sleep questionnaire survey A score of zero (0) minimal if any sleep at all versus 10 deep and sound sleeping during hospital stay.

Effects of Lavender Oil on Mood

时间窗: Pre-operatively, Post-op Day 1 (POD1), Final Post-op Day (Final POD)

Assess anxiety by hospital anxiety depression scale survey This 14-component scoring system is used to tabulate a total sum score (0-42) or separate anxiety and depression scores (0-21). A higher score represents a more severe degree of anxiety and/or depression. The severity of a patient's anxiety or depression may then be grouped into three categories based on the score (Normal, 0-7; Borderline abnormal, 8-10; Abnormal 11-21).

次要结局

未报告次要终点

研究者

发起方
Scott Hollenbeck, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Scott Hollenbeck, MD

Surgeon

Duke University

研究点 (1)

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