## Protocol Section
### Identification Module
**NCT ID:** NCT03708679

**Brief Title:** Effects of Menstrual Cycle on Preoperative Anxiety

**Official Title:** Are Menstruel Cycle Phases Effective on Preoperative Anxiety? Prospective, Clinical Study

#### Organization Study ID Info
**ID:** Menstruel Cycle Anxiety
#### Organization
**Class:** OTHER
**Full Name:** Yuzuncu Yıl University
### Status Module
#### Completion Date
**Date:** 2018-12-20

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-01-08

**Type:** ACTUAL

**Last Update Submit Date:** 2019-01-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-11-30

**Type:** ACTUAL

#### Start Date
**Date:** 2018-09-15

**Type:** ACTUAL

**Status Verified Date:** 2019-01

#### Study First Post Date
**Date:** 2018-10-17
**Type:** ACTUAL
**Study First Submit Date:** 2018-10-13
**Study First Submit QC Date:** 2018-10-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Yuzuncu Yıl University

#### Responsible Party

**Investigator Affiliation:** Yuzuncu Yıl University

**Investigator Full Name:** Nureddin YUZKAT

**Investigator Title:** Assist. Prof

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Menstrual Cycle

- Perioperative Hypertension

- Anxiety

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ACTUAL

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Month

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase)

**Label:** Group F

#### Arm Group 2

**Description:** Patients with menstrual cycle between 20-24 were called Group L (Luteal phase)

**Label:** Group L

### Outcomes Module

#### Primary Outcomes

**Description:** Preoperative anxiety level will be measured by State-Trait Anxiety Inventory (STAI) form.

**Measure:** Preoperative Anxiety

**Time Frame:** 1 month

### Eligibility Module

**Eligibility Criteria:** 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)

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.

**Gender Based:** True

**Gender Description:** The study is performed on female gender with menstrual cycle.

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** It will be operated for elective surgery, aged 18 to 45 years, who were accepted to participate in the study,

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Van

**Country:** Turkey

**Facility:** Van yuzuncu Yıl University, Dursun Odabas Medical Center

#### Overall Officials

**Official 1:**

**Affiliation:** Yuzuncu Yıl University

**Name:** Nureddin Yuzkat, Assist Prof

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: HIGH

- As Found: Anxiety

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001008

- Term: Anxiety Disorders

### Misc Info Module

- Version Holder: 2024-05-24
