Effect of Aromatherapy Versus Gum Chewing on Preoperative Anxiety in Females Undergoing Gynecological Laparoscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Preoperative anxiety scale assessed by STAI questionnaire
研究概览
简要总结
Investigators hypothesized that the use of blend aromatherapy and gum chewing before surgery would reduce preoperative anxiety as assessed by the Speilberger State-Trait Anxiety Inventory (STAI) questionnaire and provide non pharmacological methods to decrease postoperative sore throat, postoperative nausea & vomiting and postoperative pain.
详细描述
A written informed consent will be taken from the patients.patients will be assigned randomly to three groups (30 subjects each) either with preoperative aromatherapy (Group A) or gum chewing (Group G) or control group (Group C) to assess the preoperative anxiety and postoperative sore throat, nausea & vomiting and pain control between the three studied groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Educated adult females
- •American Society of Anesthesiologists (ASA) physical status I-II
- •Listed for elective gynecological laparoscopy surgery under general anesthesia and endotracheal tube (ETT)
排除标准
- •Impaired pharyngeal or esophageal function
- •Phenylketonuria (contraindication to the sweetener aspartame in chewing gum)
- •A fall upper or lower denture (not feasible to chew gum)
- •A history of preoperative sore throat, upper respiratory tract illness
- •Using steroid or analgesia within the last 48 hour
- •Chronic smokers
- •Receiving warfarin, heparin, full dose 325 mg aspirin, or clopidogrel
- •A history or diagnosis of bleeding diatheses
- •Any known allergies to ginger or lavender
- •Having head or neck surgery
- •History of difficult intubation
- •Pregnant women
结局指标
主要结局
Preoperative anxiety scale assessed by STAI questionnaire
时间窗: Preoperative 15 minutes
The STAI takes less than 5 minutes to complete and can be scored in less than 2 minutes. There are 20 questions (I feel calm, secure, tense, strained, at ease, upset, am presently worrying over possible misfortunes, satisfied, frightened, uncomfortable, self-confident, nervous, jittery, indecisive, relaxed, content, worried, confused, steady and pleasant) where people rate their anxiety from one (not at all) to four (very much so), and scores range from 20 to 80. For example, low anxiety is 20 to 37, moderate anxiety is 38 to 44, and high anxiety is 45 to 80. Assessment will be done at two times; first time (before study intervention)15 minutes preoperatively in the holding area as a baseline with recoding systolic blood pressure, diastolic blood pressure, heart rate and respiratory rate. Second time; (after study intervention) in the operating room before induction of anesthesia
次要结局
- Postoperative nausea and vomiting (PONV) score(Postoperative 24 hour)
- Postoperative sore throat (POST) score(Postoperative 24 hour)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University