The Effect of Awareness on Preoperative Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03389581
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : July 24, 2018
Information provided by (Responsible Party):
Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital

Brief 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.

Condition or disease Intervention/treatment
Anxiety Anesthesia Behavioral: awareness and anxiety

Detailed 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.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Effect of Awareness on Preoperative Anxiety Before Anesthesia
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : June 1, 2018
Estimated Study Completion Date : September 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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

Primary Outcome Measures :
  1. awareness [ Time Frame: preoperative visit before surgery ]
    modify Brice Score

Secondary Outcome Measures :
  1. anxiety [ Time Frame: preoperative visit before general anesthesia ]
    The State and Trait Anxiety Inventory (STAI-S) score will used

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18-70
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
elective surgery for any reason

Inclusion Criteria:

  • all patients between 18-70 yr

Exclusion Criteria:

  • dementia
  • psychiatric disorders
  • using antipsychotic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03389581

University of Health Siences Diskapi Yildirim Beyazit T&R hospital Recruiting
Ankara, Turkey
Contact: SAVAS ALTINSOY    +903125962553   
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital

Responsible Party: Savas Altinsoy, Principal Investigator, Diskapi Yildirim Beyazit Education and Research Hospital Identifier: NCT03389581     History of Changes
Other Study ID Numbers: awareness
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders