NCT03708679

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

October 13, 2018

Last Update Submit

January 6, 2019

Conditions

Menstrual CyclePerioperative HypertensionAnxiety

Outcome Measures

Primary Outcomes (1)

  • Preoperative Anxiety

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

    1 month

Study Arms (2)

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)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study is performed on female gender with menstrual cycle.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Van yuzuncu Yıl University, Dursun Odabas Medical Center

Van, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Nureddin Yuzkat, Assist Prof

    Yuzuncu Yil University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 17, 2018

Study Start

September 15, 2018

Primary Completion

November 30, 2018

Study Completion

December 20, 2018

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

TU(1)