Preoperative EvaluationNCT06849583
Comparison of the Effects of Preoperative Anesthesia Evaluation on Preoperative Anxiety Using Anxiety Scales and Evaluation of Patient Satisfaction
An observational study of Preoperative Evaluation and Preoperative Anxiety, run by Naime Yalçın at 1 site in Turkey (Türkiye).
Trial summary
To measure the degree of preoperative anxiety with the STAIT, APAIS and VAS anxiety scales before and after the preoperative anesthesia evaluation in patients who applied for preoperative anesthesia evaluation for elective surgical procedures and to investigate prospectively the effect of the preoperative anesthesia… Read more about this study
- Who is it for?
- Ages 16 to 85 years
- Conditions the study is for
- Preoperative Evaluation, Preoperative Anxiety, STAI
- How many people
- 500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2019to 15 Dec 2025
- 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: This study was prepared as an observational prospective study. Patients between the ages of 16-85 who apply for preoperative anesthesia evaluation for elective surgical procedures by an anesthesiologist in the Anesthesia Polyclinic will be invited to the study. The effect of preoperative anesthesia evaluation on preoperative anxiety will be investigated with the help of anxiety scales.
Who may be able to join
- Planned to undergo elective surgery
- 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
- Patients under the age of 16
- Patients who do not consent
- Those who do not have sufficient language skills
- Those with mental and/or psychiatric disorders
- Emergency and/or ASA-IV patients
- Those with a history of 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: Comparison of the Effects of Preoperative Anesthesia Evaluation on Preoperative Anxiety Using Anxiety Scales and Evaluation of Patient Satisfaction; Prospective Study
To measure the degree of preoperative anxiety with the STAIT, APAIS and VAS anxiety scales before and after the preoperative anesthesia evaluation in patients who applied for preoperative anesthesia evaluation for elective surgical procedures and to investigate prospectively the effect of the preoperative anesthesia interview on anxiety and to evaluate patient satisfaction.
Read the detailed description
Anxiety is one of the diseases that has recently attracted worldwide attention and seriously affects daily life. Preoperative anxiety is a significant problem for patients because it causes physical problems as well as emotional and psychiatric disorders. It negatively affects surgery, anesthesia and postoperative recovery and is seen in 60-80% of patients scheduled for surgery. Most patients experience varying degrees of anxiety and fear before surgery. This anxiety and fear may depend on the type of anesthesia, as well as the patient's previous experiences, personality traits, concerns about the surgical procedure and postoperative pain. Preoperative anxiety causes difficulties in anesthesia induction, autonomic fluctuations and increased anesthetic requirements, and has been associated with increased pain, nausea and vomiting, prolonged recovery and prolonged hospitalization in the postoperative period. Anxious patients encounter complications in the perioperative period at a higher incidence. Anxiety assessment is important because anxious patients' responses to anesthesia and analgesia are different than those of non-anxious patients. For this purpose, anxiety can be assessed in many ways, directly by measuring plasma cortisol and urinary catecholamines, and indirectly by measuring pulse and blood pressure.
Preoperative anxiety begins when the surgical procedure is planned and reaches its maximum intensity at hospital admission. Correct management of fear and anxiety is achieved by a better preoperative assessment and information provided by anesthesiologists. Therefore, anxious patients should be routinely identified during preoperative assessment.
In practice, there are different anxiety scales that can be used to define patient anxiety within a limited time. Many documents have been reported on the assessment of preoperative anxiety. One of these is the State-Trait Anxiety Inventory (STAI) scale, which is the most widely used test for assessing anxiety at a specific time. In addition, the Amsterdam Preoperative Anxiety and Information Scale (APAIS), which is simpler and less time-consuming to apply, was developed to measure anxiety and desire for information related to anesthesia and surgery, and its usability and correlation with STAI were investigated. The Visual Analog Scale (VAS) (range 0-100 mm) is an alternative scale used to assess anxiety, consisting of a 100 mm line; zero on the left indicates no anxiety, while 100 mm on the right indicates extreme anxiety.
Previous studies have identified that patients feel anxious before elective surgery, but studies investigating the effect of preassessment clinics (PACs) on anxiety levels have been limited to the use of patient information literature or multimedia rather than the preoperative anesthesia consultation process. Since PACs have the potential to provide patients with a better understanding of their anesthesia and surgery, they have the potential to reduce anxiety.
The aim of this study was to measure the degree of preoperative anxiety in patients presenting to our anesthesia outpatient clinic before and after the preoperative anesthesia assessment using the STAIT, APAIS and VAS anxiety scales, and to investigate the effect of the preoperative anesthesia interview on anxiety and to evaluate patient satisfaction.
- Conditions
- Preoperative Evaluation, Preoperative Anxiety, STAI, Visual Analogy Scala, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
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 Preinterview | Not described | |
| Arm Postinterview | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety scales (State- Trait Anxiety Inventory , Amsterdam Preoperative Anxiety and Information Scale , Visuel Analog Skala )
To measure the degree of preoperative anxiety in adult patients admitted to our anesthesia clinic using the STAIT, APAIS and VAS anxiety scales before and after preoperative anesthesia evaluation and to prospectively investigate the effect of the preoperative anesthesia interview on anxiety and to evaluate patient satisfaction.The Visual Analog Scale (VAS) (range 0-100 mm) is an alternative scale used in the assessment of anxiety, consisting of a 100 mm line; zero on the left indicates no anxiety, while 100 mm on the right indicates extreme anxiety. In the Spielberger State-Trait Anxiety Inventory (STAI), patients with a score of 45 and above will be considered highly anxious (mild ≤39, moderate = 40-45, severe ≥46). In the Amsterdam Preoperative Anxiety and Information Scale (APAIS), patients with an APAIS-A score greater than 10 will be considered highly anxious. Patients with an APAIS-B score of 5 and above will be considered to have a need for information.
Measured: Three days from registration to completion and evaluation of all patient questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start15 Mar 2019
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative EvaluationStudies 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
- 500 participants (estimated)
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
- NCT06849583
- Sponsor's protocol ID
- KAEK/2019.02.31
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 27 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Preoperative Anesthesia Evaluation on Preoperative Anxiety Using Anxiety Scales and Evaluation of Patient Satisfaction; Prospective Study
- ClinicalTrials.gov ID
- NCT06849583
- Acronym / sponsor ID
- KAEK/2019.02.31
- Conditions
- Preoperative Evaluation, Preoperative Anxiety, STAI, Visual Analogy Scala, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Naime YalçınUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 27 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.
To measure the degree of preoperative anxiety with the STAIT, APAIS and VAS anxiety scales before and after the preoperative anesthesia evaluation in patients who applied for preoperative anesthesia evaluation for elective surgical procedures and to investigate prospectively the effect of the preoperative anesthesia interview on anxiety and to evaluate patient satisfaction.
Detailed description
Anxiety is one of the diseases that has recently attracted worldwide attention and seriously affects daily life. Preoperative anxiety is a significant problem for patients because it causes physical problems as well as emotional and psychiatric disorders. It negatively affects surgery, anesthesia and postoperative recovery and is seen in 60-80% of patients scheduled for surgery. Most patients experience varying degrees of anxiety and fear before surgery. This anxiety and fear may depend on the type of anesthesia, as well as the patient's previous experiences, personality traits, concerns about the surgical procedure and postoperative pain. Preoperative anxiety causes difficulties in anesthesia induction, autonomic fluctuations and increased anesthetic requirements, and has been associated with increased pain, nausea and vomiting, prolonged recovery and prolonged hospitalization in the postoperative period. Anxious patients encounter complications in the perioperative period at a higher incidence. Anxiety assessment is important because anxious patients' responses to anesthesia and analgesia are different than those of non-anxious patients. For this purpose, anxiety can be assessed in many ways, directly by measuring plasma cortisol and urinary catecholamines, and indirectly by measuring pulse and blood pressure.
Preoperative anxiety begins when the surgical procedure is planned and reaches its maximum intensity at hospital admission. Correct management of fear and anxiety is achieved by a better preoperative assessment and information provided by anesthesiologists. Therefore, anxious patients should be routinely identified during preoperative assessment.
In practice, there are different anxiety scales that can be used to define patient anxiety within a limited time. Many documents have been reported on the assessment of preoperative anxiety. One of these is the State-Trait Anxiety Inventory (STAI) scale, which is the most widely used test for assessing anxiety at a specific time. In addition, the Amsterdam Preoperative Anxiety and Information Scale (APAIS), which is simpler and less time-consuming to apply, was developed to measure anxiety and desire for information related to anesthesia and surgery, and its usability and correlation with STAI were investigated. The Visual Analog Scale (VAS) (range 0-100 mm) is an alternative scale used to assess anxiety, consisting of a 100 mm line; zero on the left indicates no anxiety, while 100 mm on the right indicates extreme anxiety.
Previous studies have identified that patients feel anxious before elective surgery, but studies investigating the effect of preassessment clinics (PACs) on anxiety levels have been limited to the use of patient information literature or multimedia rather than the preoperative anesthesia consultation process. Since PACs have the potential to provide patients with a better understanding of their anesthesia and surgery, they have the potential to reduce anxiety.
The aim of this study was to measure the degree of preoperative anxiety in patients presenting to our anesthesia outpatient clinic before and after the preoperative anesthesia assessment using the STAIT, APAIS and VAS anxiety scales, and to investigate the effect of the preoperative anesthesia interview on anxiety and to evaluate patient satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Preinterview | – | – |
| Arm Postinterview | – | – |
Who may qualify
- Ages
- 16 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study was prepared as an observational prospective study. Patients between the ages of 16-85 who apply for preoperative anesthesia evaluation for elective surgical procedures by an anesthesiologist in the Anesthesia Polyclinic will be invited to the study. The effect of preoperative anesthesia evaluation on preoperative anxiety will be investigated with the help of anxiety scales.
Key inclusion criteria (5 listed)
- Planned to undergo elective surgery
- 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)
- Patients under the age of 16
- Patients who do not consent
- Those who do not have sufficient language skills
- Those with mental and/or psychiatric disorders
- Emergency and/or ASA-IV patients
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
Anxiety scales (State- Trait Anxiety Inventory , Amsterdam Preoperative Anxiety and Information Scale , Visuel Analog Skala )
Time frame: Three days from registration to completion and evaluation of all patient questionnaires
To measure the degree of preoperative anxiety in adult patients admitted to our anesthesia clinic using the STAIT, APAIS and VAS anxiety scales before and after preoperative anesthesia evaluation and to prospectively investigate the effect of the preoperative anesthesia interview on anxiety and to evaluate patient satisfaction.The Visual Analog Scale (VAS) (range 0-100 mm) is an alternative scale used in the assessment of anxiety, consisting of a 100 mm line; zero on the left indicates no anxiety, while 100 mm on the right indicates extreme anxiety. In the Spielberger State-Trait Anxiety Inventory (STAI), patients with a score of 45 and above will be considered highly anxious (mild ≤39, moderate = 40-45, severe ≥46). In the Amsterdam Preoperative Anxiety and Information Scale (APAIS), patients with an APAIS-A score greater than 10 will be considered highly anxious. Patients with an APAIS-B score of 5 and above will be considered to have a need for information.
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 27 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 Evaluation and Preoperative Anxiety, 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 27 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?
Anxiety scales (State- Trait Anxiety Inventory , Amsterdam Preoperative Anxiety and Information Scale , Visuel Analog Skala ) (time frame: Three days from registration to completion and evaluation of all patient questionnaires). 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 27 Feb 2025.