The Effect of Awareness on Preoperative Anxiety

July 21, 2020 updated by: Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital

The Effect of Awareness on Preoperative Anxiety Before Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

799

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • university of health siences diskapi yildirim beyazit T&R hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

elective surgery for any reason

Description

Inclusion Criteria:

  • all patients between 18-70 yr

Exclusion Criteria:

  • dementia
  • psychiatric disorders
  • using antipsychotic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
awareness
Time Frame: preoperative visit before surgery
modify Brice Score
preoperative visit before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiety
Time Frame: preoperative visit before general anesthesia
The State and Trait Anxiety Inventory (STAI-S) score will used
preoperative visit before general anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2018

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

September 20, 2018

Study Registration Dates

First Submitted

December 26, 2017

First Submitted That Met QC Criteria

December 26, 2017

First Posted (Actual)

January 3, 2018

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • awareness

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on awareness and anxiety

3
Subscribe