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CompletedNCT03389581Updated Jul 22, 2020

The Effect of Awareness on Preoperative Anxiety

An observational study in Anxiety and Anesthesia, sponsored by Diskapi Yildirim Beyazit Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-22.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Diskapi Yildirim Beyazit Education and Research Hospital · Observational

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Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
799
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anxiety
  • Anesthesia

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03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 799 is above the median of 168 across 978 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital is the lead sponsor of 71 studies on the registry; 12 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

elective surgery for any reason

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • all patients between 18-70 yr

Exclusion criteria

Exclusion Criteria:

  • dementia
  • psychiatric disorders
  • using antipsychotic
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
799 participants (actual)
Patient registry
No

Interventions

  • Behavioralawareness and anxiety

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

06

What researchers measure

Primary outcomes

  1. awareness

    modify Brice Score

    Time frame: preoperative visit before surgery

Secondary outcomes

  1. anxiety

    The State and Trait Anxiety Inventory (STAI-S) score will used

    Time frame: preoperative visit before general anesthesia

07

Study locations

1 site
  • University of Health Siences Diskapi Yildirim Beyazit T&R hospital
    Ankara, Turkey
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Jun 2018, 4 months.

Of 411 non-industry observational studies under Anxiety Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 49. This study's 4 months is below that.

Counting every sponsor, half of 439 studies reached it within 19 months; a quarter within 6 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 26, 2017
First posted
Jan 3, 2018
StartActual
Jan 8, 2018
Primary completionActual
Jun 1, 2018
CompletionActual
Sep 20, 2018
Last update
Jul 22, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03389581
Lead sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Responsible party
Savas Altinsoy (Principal Investigator, Diskapi Yildirim Beyazit Education and Research Hospital) — Principal investigator
First posted
Jan 3, 2018
Start date
Jan 8, 2018
Primary completion
Jun 1, 2018
Completion
Sep 20, 2018
Last update
Jul 22, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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