NCT03389581

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
799

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 26, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

January 8, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

5 months

First QC Date

December 26, 2017

Last Update Submit

July 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • awareness

    modify Brice Score

    preoperative visit before surgery

Secondary Outcomes (1)

  • anxiety

    preoperative visit before general anesthesia

Interventions

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18-70
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

elective surgery for any reason

You may qualify if:

  • all patients between 18-70 yr

You may not qualify if:

  • dementia
  • psychiatric disorders
  • using antipsychotic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Siences Diskapi Yildirim Beyazit T&R hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 26, 2017

First Posted

January 3, 2018

Study Start

January 8, 2018

Primary Completion

June 1, 2018

Study Completion

September 20, 2018

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations