Effects of Menstrual Cycle on Preoperative Anxiety
Condition: Menstrual Cycle; Perioperative Hypertension; Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational [Patient Registry]

Summary: 
      The investigators aimed to investigate the effect of menstrual cycle phases on preoperative
      anxiety in women under general anesthesia.
    

Detailed description: 
      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.

      The study groups were selected from patients who presented to the preop anesthesia polyclinic
      in elective conditions, septo-rinoplasty operation under general anesthesia. Assuming that
      there would be a 5-point difference in anxiety scores among the groups, it was decided to
      take 40 cases for each group with a 0.75 standard effect size, 80% power, and 5% error.
      Patients were randomly assigned to two groups of 40 patients. The patients were randomized by
      sequential addition to the groups determined in the order of their inclusion.

      Study inclusion criteria: 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).

      Study exclusion criteria: 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.

      Groups:

      Information about menstrual cycle patterns was obtained from all cases. The days of the
      menstrual cycle will be determined starting from counting the first day of the last cycle.
      Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase).
      Patients with menstrual cycle between 20-24 were called Group L (Luteal phase). The follow-up
      of the cases and the recording of the measurements were performed by an anesthesiologist who
      did not know which group the cases were in.

      Procedure to be Applied:

      The sex, age, height and ASA scores of the patients were recorded preoperatively. The STAI
      instantaneous anxiety inventory, which measures situational anxiety in the preop unit, will
      be completed. In this form, there are 20 expressions, each is scored between the values of 1
      to 4.

      The total STAI score will be determined by subtracting the sum of the scores given to the
      expressions expressing positive emotions (1, 2, 5, 8, 10, 11, 15, 16, 19 and 20) from the sum
      of the scores given to the expressions expressing negative emotions (3, 4, 6, 7, 9, 12, 13,
      14, 17 ve 18), then constant 50 number will be added to this value.

      In preop unit and operation room, hemodynamic parameters (systolic, diastolic and mean
      arterial pressure (MAP), heart rate (HR) and peripheral oxygen saturation values preop at
      15th, 10th, 5th, before induction, after induction at 1th and intubation at 1st, 5th and 15th
      minutes will be recorded.

      Instead of patients who do not want to be included in the study or who are excluded from the
      study for any reason, according to the results of the power analysis, a targeted number of
      patients will be included in the study randomly.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        It will be operated for elective surgery, aged 18 to 45 years, who were accepted to
        participate in the study,