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AnxietyNCT07559461

Fear and Anxiety in Anesthesia-Naïve Patients Pre-operatively vs Post-operatively

An observational study of Anxiety and Anesthesia Awareness, run by Stony Brook University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety, Anesthesia Awareness
What is being tested?
Survey using a questionnaire.
How many people
40 participants
Where
1 siteUnited States
Study dates
12 Feb 2026to Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients over 18 who have never received anesthesia before that are scheduled to undergo a low-risk surgery/procedure at Stony Brook University Hospital, Stony Brook Ambulatory Surgery Center, or Stony Brook Ambulatory Care Pavilion.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Suske contact

631-638-1214

anna.suske@stonybrookmedicine.edu

United States1 site, 1 recruiting

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Anna Suske, 631-638-1214, anna.suske@stonybrookmedicine.edu

    Ana Costa, MD, 631-358-6513, ana.costa@stonybrookmedicine.edu

    Recruiting

Other trials in United States

About this study

Official title: 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:

  1. Fill out a survey before their surgery in the perioperative setting
  2. Answer follow-up questions over the phone a few days after their surgery.
Read the detailed description

Patients that fit the inclusion/exclusion criteria and consent to the study will fill out a paper survey that is an adapted version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS) along with additional questions related to anesthesia anxiety for secondary analysis. 7 days (+/-72 hours) after the patient's surgery, they will complete a follow-up survey over the phone that is an adapted version of the APAIS. Results will be recorded on paper and then uploaded into REDCap for data analysis.

Being tested
Survey using a questionnaire.
Keywords
Anesthesia-naïve, Anxiety
Medical subject headings
Anxiety Disorders, Intraoperative Awareness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Survey using a questionnaire.Other

    A preoperative and postoperative survey questionnaire that is adapted from the Amsterdam Preoperative Anxiety and Information Scale and includes additional questions regarding their anesthesia and operative care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients

    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.

    Measured: From enrollment until 7 days (+/-72 hours) post-operative

Secondary outcomes (2)

  1. 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.

    This data will be collected from the pre-operative and post-operative survey questionnaires and evaluated for correlation.

    Measured: From enrollment until 7 days (+/-71 hours) post-operative

  2. Comparing the frequency of specific fears of events pre-operatively versus the post-operative reality of the individual subject's anesthesia experience.

    This data will be collected from the pre-operative and post-operative survey questionnaires and will be evaluated.

    Measured: From enrollment until 7 days (+/-71 hours) post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2026
  2. Study start12 Feb 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07559461
Sponsor's protocol ID
IRB2024-00359
Status last verified
Apr 2026
First submitted
23 Apr 2026
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 36803738

  • 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.

    PubMed 39653328

  • 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.

    PubMed 32228525

  • 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.

    PubMed 22864564

  • 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.

    PubMed 6363534

  • 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.

    PubMed 8942601

  • 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.

    PubMed 30205837

  • 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.

    PubMed 28217078

Questions about this trial

What is this clinical trial studying?

An observational study of Anxiety and Anesthesia Awareness, run by Stony Brook University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Suske (631-638-1214, anna.suske@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients (time frame: From enrollment until 7 days (+/-72 hours) post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07559461, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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