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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03389581
Other study ID # awareness
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 8, 2018
Est. completion date September 20, 2018

Study information

Verified date July 2020
Source Diskapi Yildirim Beyazit Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the majority of patients, anxiety and fear are observed at different levels before surgery. Preoperative anxiety was reported in 60-80% of the patients who underwent surgery. This anxiety and fear can be attributed to many factors. Some of these are mainly anesthesia, previous experience of the patient, personality traits, concerns about surgical intervention, and postoperative pain. Patients' anxiety levels can be influenced by a variety of factors, including previous experience, type of hospital arrival, sex, age, and type of surgery.Anesthesia-related awareness among the experiences of anesthesia is described in the literature. In a study of 20,402 patients in the United States, the awareness rate was 0.13%. Being aware is that the patient is awake during the surgery and recalls seeing bad dreams. At that time the patient could not specify this because he was immobile. Being awake is that the patient is awake and showing it through his movements. The patient may not remember this situation later. It is a condition that can always be overlooked in previous experience, which is an important parameter of anxiety in the preoperative period. The patients included in the study were planned to use the modified Brice awareness score, first mentioned in 1970 as the name of the person who used the anesthesia and anesthesia for awareness. In this study, investigators aim to reveal the effect of anesthesia awareness on preoperative anxiety in patients with previous anesthesia story.


Description:

in this study will include 300 patients. 300 patients will be enrolled in the anesthesia outpatient clinic scheduled for elective surgery for any reason at the age of 18-65 years. Patients with dementia and psychiatric disorders, anxiolytic and psychiatric drug users and patients who can not receive written approval will be excluded from the study.


Recruitment information / eligibility

Status Completed
Enrollment 799
Est. completion date September 20, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- all patients between 18-70 yr

Exclusion Criteria:

- dementia

- psychiatric disorders

- using antipsychotic

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
awareness and anxiety
before operation awareness and anxiety will recorded with STAIX-I score

Locations

Country Name City State
Turkey University of Health Siences Diskapi Yildirim Beyazit T&R hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary awareness modify Brice Score preoperative visit before surgery
Secondary anxiety The State and Trait Anxiety Inventory (STAI-S) score will used preoperative visit before general anesthesia
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