Preoperative AnxietyNCT06837415
Association Between Preoperative Anxiety and Blood Eosinophil Levels
An observational study of Preoperative Anxiety and Preoperative Evaluation, run by Naime Yalçın at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Preoperative Anxiety, Preoperative Evaluation, STAI
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Nov 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, 34000
About this study
Official title: Association Between Preoperative Anxiety and Blood Eosinophil Levels; a Prospective Study.
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.
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 |
|---|---|---|
| Arm control | Not described | |
| Arm eosinophilia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between blood eosinophil count and preoperative anxiety
Measured: 1 day (From enrollment to the end of completion of the survey forms)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 May 2019
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Naime Yalçın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naime Yalçın, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837415
- Sponsor's protocol ID
- KAEK/2019.04.98
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 21 Feb 2025
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Preoperative Anxiety and Blood Eosinophil Levels; a Prospective Study.
- ClinicalTrials.gov ID
- NCT06837415
- Acronym / sponsor ID
- KAEK/2019.04.98
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Naime YalçınUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 20 Feb 2025 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm control | – | – |
| Arm eosinophilia | – | – |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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
Correlation between blood eosinophil count and preoperative anxiety
Time frame: 1 day (From enrollment to the end of completion of the survey forms)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Preoperative Anxiety and Preoperative Evaluation, run by Naime Yalçın 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 6 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: enrolling by invitation, as of the sponsor's last update on 21 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between blood eosinophil count and preoperative anxiety (time frame: 1 day (From enrollment to the end of completion of the survey forms)). 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 21 Feb 2025.