NCT06849583

Brief 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 interview on anxiety and to evaluate patient satisfaction.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2019

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 27, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

6.5 years

First QC Date

February 14, 2025

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Three days from registration to completion and evaluation of all patient questionnaires

Study Arms (2)

Arm Preinterview

Arm Postinterview

Eligibility Criteria

Age16 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sağlık Bilimleri Üniversitesi Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Anesthesiology and Reanimation, Principal Investigator

Study Record Dates

First Submitted

February 14, 2025

First Posted

February 27, 2025

Study Start

March 15, 2019

Primary Completion

September 15, 2025

Study Completion

December 15, 2025

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations