Are Menstruel Cycle Phases Effective on Preoperative Anxiety? Prospective, Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Preoperative Anxiety
研究概览
简要总结
The investigators aimed to investigate the effect of menstrual cycle phases on preoperative anxiety in women under general anesthesia.
详细描述
In preoperative period, preoperative anxiety is experienced in different degrees due to surgery and anesthesia. Preoperative anxiety is a condition that negatively affects anesthesia, surgery and postoperative recovery. It is reported that the incidence of preoperative anxiety in the western population is between 60% and 80%. In the pre-operative period, there are many causes of anxiety related to the patient's health and the concerns about the operation, uncertainty of the outcome, non-wake up after surgery, pain hearing and waking during surgery. It has been reported that anxiety increases direct blood pressure and changes pulse rate. It is stated that anxiety also affects the awakening criteria in postoperative period. This may cause hemodynamic instability in anesthesia applications.
Hormonal, physical and psychological fluctuations occur in women due to menstrual cycle. Therefore, it is reported that there is a strong relationship between the menstrual cycle and the person's emotional state. It is known that women feel good in the first phase of the cycle and they experience emotional, physical and behavioral disorders towards the end of the cycle. Studies have shown that anesthetic requirements, postoperative analgesic requirement and incidence of nausea vomiting may change with the phases of the cycle. Similarly, in the luteal phase of the cycle, it has been suggested that luteinizing hormones cause sensitization in opioid receptors and increase sensitivity to pain. In addition, depressive symptoms increase before menstruation. In this process, some women may have pre-menstrual dysphoric discomfort, irritability, mood swings, depression, flare, anger, restlessness, anorexia, sleep disturbance, and fatigue.
Our hypothesis is that preop anxiety will be higher in the surgeries planned in the luteal phase.
We aimed to investigate the effect of menstrual cycle phases on preoperative anxiety in women under general anesthesia.
Material Method Ethics Committee approval was obtained before the study. After the written consent of the patients were obtained, they started to the study. The study was planned as a randomized prospective study between February 2018 and February 2019.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The study included 80 women with ASA I-II,
- •Aged 18 to 45 years, who were accepted to participate in the study,
- •were smoking,
- •did not use oral contraceptives,
- •had no menstrual irregularity (regular 28 ± 2 days menstrual cycle)
排除标准
- •In preop evaluation patients had difficulties in communication,
- •amenorrhea,
- •pregnancy,
- •delirium,
- •psychological illness,
- •major depressive disorder,
- •patients with a history of acute illness (such as in intensive care unit follow-up),
- •which may affect cognitive function and daily life activities in the last 6 months,
- •malignancy,
- •acute renal failure,
- •substance abuse and patients older than 45 years and male sex will be excluded from the study.
结局指标
主要结局
Preoperative Anxiety
时间窗: 1 month
Preoperative anxiety level will be measured by State-Trait Anxiety Inventory (STAI) form.
次要结局
未报告次要终点
研究者
Nureddin YUZKAT
Assist. Prof
Yuzuncu Yıl University