- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07559461
Fear and Anxiety in Anesthesia-Naïve Patients Pre-operatively vs Post-operatively
Fear and Anesthesia: How Anxiety and Fear in Anesthesia-Naïve Patients Changes From Preop to Postop
The goal of this observational study is to understand how fear and anxiety felt by anesthesia-naive patients compares before versus after their scheduled surgery. Patients who are scheduled to undergo a low-risk surgery/procedure and have never had anesthesia before will be asked to:
- Fill out a survey before their surgery in the perioperative setting
- Answer follow-up questions over the phone a few days after their surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anna Suske
- Phone Number: 631-638-1214
- Email: anna.suske@stonybrookmedicine.edu
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Recruiting
- Stony Brook University Hospital
-
Contact:
- Anna Suske
- Phone Number: 631-638-1214
- Email: anna.suske@stonybrookmedicine.edu
-
Contact:
- Ana Costa, MD
- Phone Number: 631-358-6513
- Email: ana.costa@stonybrookmedicine.edu
-
Principal Investigator:
- Ana Costa, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years old or over
- Patients scheduled to undergo surgeries such as but not limited to:
cholecystectomies, appendectomies, hernia repairs, breast surgeries, plastic surgeries, thyroidectomy, parathyroidectomy, tonsillectomy, adenoidectomy, lithotripsy, stent placement, kidney stone surgeries, cystoscopies, bladder tumors, ovarian cystectomies, hysterectomies, tubal ligation, hysteroscopy, Intrauterine Device (IUD) insertion, knee replacement, hip replacement, fracture pinning, sports injury surgery such as knee and shoulder scopes. OR patients undergoing procedures such as but not limited to: colonoscopies and endoscopies
- Patient undergoing anesthesia for the first time
- Patients who are not pregnant by self report
Exclusion Criteria:
- Patients under 18
- Patients who are pregnant
- Patients undergoing high-risk surgeries
- Patients undergoing cancer-related procedures
- Non-English speaking patients
- Patients that experience mental status change postoperatively as determined by the medical teams caring for the patient
- Patients with an existing anxiety disorder, or psychiatric diagnoses
- Patients on benzodiazepines, antidepressants, chronic opioids
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients
Time Frame: From enrollment until 7 days (+/-72 hours) post-operative
|
Participants will be given 2 scores based on their pre-operative survey and their post-operative survey.
The change in anxiety score will be evaluated.
|
From enrollment until 7 days (+/-72 hours) post-operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determining if there is an association between a pre-operative desire for information related to anesthesia and the post-operative reality of the individual subject's anesthesia experience.
Time Frame: From enrollment until 7 days (+/-71 hours) post-operative
|
This data will be collected from the pre-operative and post-operative survey questionnaires and evaluated for correlation.
|
From enrollment until 7 days (+/-71 hours) post-operative
|
|
Comparing the frequency of specific fears of events pre-operatively versus the post-operative reality of the individual subject's anesthesia experience.
Time Frame: From enrollment until 7 days (+/-71 hours) post-operative
|
This data will be collected from the pre-operative and post-operative survey questionnaires and will be evaluated.
|
From enrollment until 7 days (+/-71 hours) post-operative
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ana Costa, MD, Stony Brook University
Publications and helpful links
General Publications
- Celik F, Edipoglu IS. Evaluation of preoperative anxiety and fear of anesthesia using APAIS score. Eur J Med Res. 2018 Sep 11;23(1):41. doi: 10.1186/s40001-018-0339-4.
- Mavridou P, Dimitriou V, Manataki A, Arnaoutoglou E, Papadopoulos G. Patient's anxiety and fear of anesthesia: effect of gender, age, education, and previous experience of anesthesia. A survey of 400 patients. J Anesth. 2013 Feb;27(1):104-8. doi: 10.1007/s00540-012-1460-0. Epub 2012 Aug 3.
- Shafer A, Fish MP, Gregg KM, Seavello J, Kosek P. Preoperative anxiety and fear: a comparison of assessments by patients and anesthesia and surgery residents. Anesth Analg. 1996 Dec;83(6):1285-91. doi: 10.1097/00000539-199612000-00027.
- Eberhart L, Aust H, Schuster M, Sturm T, Gehling M, Euteneuer F, Rusch D. Preoperative anxiety in adults - a cross-sectional study on specific fears and risk factors. BMC Psychiatry. 2020 Mar 30;20(1):140. doi: 10.1186/s12888-020-02552-w.
- Dost B, Komurcu O, Bilgin S, Turunc E, Ozden GG, Hancioglu S, Baris S. Is Preoperative Anxiety Affected by Watching Short Videos on Social Media? A Prospective Randomized Study. J Perianesth Nurs. 2023 Oct;38(5):758-762. doi: 10.1016/j.jopan.2023.01.006. Epub 2023 Feb 16.
- Tatli U, Kalkan T. Does Social Media Increase Perioperative Anxiety in Patients Undergoing Impacted Third Molar Surgery? J Oral Maxillofac Surg. 2025 Mar;83(3):344-352. doi: 10.1016/j.joms.2024.11.010. Epub 2024 Nov 22.
- Heyman B, Wigzell H. Immunoregulation by monoclonal sheep erythrocyte-specific IgG antibodies: suppression is correlated to level of antigen binding and not to isotype. J Immunol. 1984 Mar;132(3):1136-43.
- Kilinc M, Ozer AB. Fear of going under general anesthesia: A cross-sectional study. Saudi J Anaesth. 2017 Jan-Mar;11(1):128-129. doi: 10.4103/1658-354X.197361. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2024-00359
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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