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Enrolling by invitationNCT06837415Updated Feb 21, 2025

Association Between Preoperative Anxiety and Blood Eosinophil Levels

An observational study in Preoperative Anxiety, Preoperative Evaluation and STAI, sponsored by Naime Yalçın. Enrolling by invitation at 1 site in Turkey. Open to participants aged 16 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-02-21.

Sponsored by Naime Yalçın · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
16 Years to 85 Years
Sex
All
01

Study summary

In the studies, the presence of preoperative anxiety has been evaluated and reported with anxiety scales. The presence of anxiety and allergic diseases has also been examined in a limited study with the analysis of neuroendocrine cells. In this study, it was planned to support the eosinophilia response in peripheral blood accelerated by stress-related anxiety with anxiety scales. In patients who apply to the anesthesia clinic before surgery, the preoperative anxiety level will be measured with the STAIT(The State-Trait Anxiety Inventory Test) and APAIS (The Amsterdam Preoperative Anxiety and Information Scale) scales performed before the anesthesia evaluation and the relationship with the eosinophil count in the patient's complete blood count analysis will be evaluated.

Read the detailed description

Anxiety is an unpleasant emotion that affects patient comfort. Surgery is a significant trauma and is significantly associated with patient anxiety. Postoperative pain expectations, separation from family, inadequacy, loss of independence, and fear of surgery and death increase perioperative anxiety symptoms. Therefore, preoperative anxiety has the potential to change the dynamics of an elective surgical procedure. If mismanaged, it can lead to postponement or cancellation of surgical procedures. Both outcomes have clinical and economic detrimental effects. Studies on patients undergoing elective surgery have shown that anxiety, depression, somatoform disorder, and fear of pain are frequently encountered, while the prevalence of preoperative anxiety varies between 11% and 80%, and is an important factor that increases perioperative morbidity in adults. Several factors have been associated with preoperative anxiety. These factors include low education level, female gender, age, type of surgery, marital status, social status, ASA grade, psychiatric illness, previous poor clinical experiences, specific types of surgery, smoking, and BMI. In practice, many documents have been reported in the evaluation of preoperative anxiety, and the most commonly used test is the STAI scale. In addition, the APAIS, which is simpler and less time-consuming to administer, was developed to measure anxiety and desire for information related to anesthesia and surgery, and its usability and correlation with the STAI were investigated.

Recently, a few studies have shown a relationship between anxiety and allergic diseases. The relationship between allergic symptoms and psychological disorders is complex. Chronic allergy, especially asthma, is a source of psychological distress in itself. On the other hand, dysfunctional psychological reactions have a negative effect on the perception and management of allergy symptoms. Side effects such as fatigue, weakness, joint pain, swelling, headache and psychological disorders usually accompany allergies and greatly impair the quality of life of patients. It has been reported that there is a relationship between allergy and psychological dysfunction, namely anxiety, depression and decreased ability to cope with stress, and that the frequency of anxiety in allergic patients is as high as 19%. Atopic predisposition is defined as a personal or family history of type 1 allergy, bronchial asthma, allergic rhinitis and conjunctivitis and/or atopic dermatitis and/or a tendency to overproduction of IgE (immunoglobulin E) antibodies. Some anxiety disorders have been detected in 35% of 100 cases of type I atopy. It has been shown that atopic patients have high anxiety levels, both in children and adults, and that psychotherapy improves not only the psychological but also the dermatological condition. Different studies have focused on the importance of mental stress as a cause of atopic dermatitis or asthma exacerbations in children and adults. Although the effect of stress on skin lesions is not fully understood, recent studies have shown that it both mediates anxiety and affects immune function. Acute psychological stress leads to an increase in the number of eosinophils in the peripheral blood of patients with atopic dermatitis. Eosinophilia is characterized by an increase in the number of complete peripheral eosinophils. It has three categories: mild (500-1500 /mm3), moderate (1500-5000/mm3) and severe (>5000/mm3). The clinical effect of eosinophilia is variable. Based on studies, the limit blood eosinophil value defining patients with eosinophilic asthma has been shown as 0.3 x 109 L -1. While a significant advantage in preventing exacerbations has been reported in patients with eosinophil count \<150, this advantage has not been identified in cases where the whole blood eosinophil count is >150.

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Conditions studied

  • Preoperative Anxiety
  • Preoperative Evaluation
  • STAI
  • Eosinophil Blood Count

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's planned enrollment of 400 is above the median of 150 across 606 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Naime Yalçın is the lead sponsor of 7 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study will be conducted on patients aged 16-85 years who apply for preoperative anesthesia evaluation for an elective surgical procedure by an anesthesiologist at the Health Sciences University Kanuni Sultan Süleyman E.A.H. Anesthesia Polyclinic.

Inclusion criteria

  • scheduled for elective surgery
  • Have sufficient language skills for the interview
  • Ages 16-85
  • ASA I - III
  • Patients who apply to the anesthesia clinic for anesthesia evaluation

Exclusion criteria

Exclusion Criteria:

  • under the age of 16
  • Patients who do not consent
  • Patients with insufficient language skills
  • Patients with mental and/or psychiatric disorders
  • Patients with a history of emergency and/or ASA-IV
  • sedative drug use
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Arm control
  • Arm eosinophilia
06

What researchers measure

Primary outcomes

  1. Correlation between blood eosinophil count and preoperative anxiety

    Time frame: 1 day (From enrollment to the end of completion of the survey forms)

07

Study locations

1 site
  • Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
    İstanbul, 34000, Turkey
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06837415
Lead sponsor
Naime Yalçın
Responsible party
Naime Yalçın (Specialist Anesthesiology and Reanimation, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital) — Sponsor-investigator
First posted
Feb 20, 2025
Start date
May 1, 2019
Primary completion
Sep 1, 2025 (estimated)
Completion
Nov 1, 2025 (estimated)
Last update
Feb 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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