Menstrual CycleNCT03708679
Effects of Menstrual Cycle on Preoperative Anxiety
An observational study of Menstrual Cycle and Perioperative Hypertension, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to investigate the effect of menstrual cycle phases on preoperative anxiety in women under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menstrual Cycle, Perioperative Hypertension, Anxiety
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2018to 20 Dec 2018
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: It will be operated for elective surgery, aged 18 to 45 years, who were accepted to participate in the study,
Who may be able to join
- 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)
Who cannot join
- In preop evaluation patients had difficulties in communication,
- amenorrhea,
- pregnancy,
- delirium,
- psychological illness,
- major depressive disorder,
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van yuzuncu Yıl University, Dursun Odabas Medical Center
Van
About this study
Official title: Are Menstruel Cycle Phases Effective on Preoperative Anxiety? Prospective, Clinical Study
The investigators aimed to investigate the effect of menstrual cycle phases on preoperative anxiety in women under general anesthesia.
Read the 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
- Menstrual Cycle, Perioperative Hypertension, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group F | Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase) | |
| Group L | Patients with menstrual cycle between 20-24 were called Group L (Luteal phase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Anxiety
Preoperative anxiety level will be measured by State-Trait Anxiety Inventory (STAI) form.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start15 Sep 2018
- Primary completion30 Nov 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nureddin YUZKAT, Yuzuncu Yil University
- Investigators
- Nureddin Yuzkat, Assist Prof, Study chair, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708679
- Sponsor's protocol ID
- Menstruel Cycle Anxiety
- Status last verified
- Jan 2019
- First submitted
- 13 Oct 2018
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Menstruel Cycle Phases Effective on Preoperative Anxiety? Prospective, Clinical Study
- ClinicalTrials.gov ID
- NCT03708679
- Acronym / sponsor ID
- Menstruel Cycle Anxiety
- Conditions
- Menstrual Cycle, Perioperative Hypertension, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group F | – | –Patients with menstrual cycle between 8-12 days were called Group F (Follicular phase) |
| Group L | – | –Patients with menstrual cycle between 20-24 were called Group L (Luteal phase) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- It will be operated for elective surgery, aged 18 to 45 years, who were accepted to participate in the study,
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (11 listed)
- In preop evaluation patients had difficulties in communication,
- amenorrhea,
- pregnancy,
- delirium,
- psychological illness,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Preoperative Anxiety
Time frame: 1 month
Preoperative anxiety level will be measured by State-Trait Anxiety Inventory (STAI) form.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nureddin Yuzkat, Assist Prof study chair
Yuzuncu Yil University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle and Perioperative Hypertension, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Anxiety (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2019.