- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03389581
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
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiRecruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Yale UniversityNational Institute of Mental Health (NIMH)Active, not recruitingGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Nazife Begüm KARANCompletedDental Anxiety | Sedative; Anxiety DisorderTurkey
-
Loyola UniversityCompletedAnxiety | Anxiety State | Procedural AnxietyUnited States
-
Eli Lilly and CompanyCompletedAnxiety Neuroses | Anxiety States, Neurotic | Neuroses, AnxietyUnited States, Mexico, South Africa
-
West University of TimisoaraUnknownAnxiety Disorder/Anxiety StateRomania
-
Dr. Nazanin AlaviActive, not recruitingGeneralized Anxiety Disorder | AnxietyCanada
-
ProofPilotFisher WallaceActive, not recruitingGeneralized Anxiety Disorder | Anxiety | Generalized AnxietyUnited States
Clinical Trials on awareness and anxiety
-
New York UniversityRecruitingMindfulness | Social Discrimination | Sexual and Gender MinoritiesUnited States
-
Hacettepe UniversityUnknown
-
Istanbul Medipol University HospitalNot yet recruiting
-
Lund UniversityVastra Gotaland RegionCompleted
-
William D. KillgoreUnited States Department of DefenseCompleted
-
VA Office of Research and DevelopmentRecruitingSchizophrenia | Bipolar Disorder | Suicide | Post Traumatic Stress Disorder | Major Depressive DisorderUnited States
-
Seattle Children's HospitalUniversity of Washington; National Center for Complementary and Integrative...UnknownSleep Initiation and Maintenance DisordersUnited States
-
University of UtahWayne State UniversityRecruiting
-
University Hospital, AngersUnknown
-
Istituto per la Ricerca e l'Innovazione BiomedicaComune di MessinaRecruitingAutism Spectrum Disorder | AutismItaly