- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Anna Suske
- Telefonnummer: 631-638-1214
- E-mail: anna.suske@stonybrookmedicine.edu
Studiesteder
-
-
New York
-
Stony Brook, New York, Forenede Stater, 11794
- Rekruttering
- Stony Brook University Hospital
-
Kontakt:
- Anna Suske
- Telefonnummer: 631-638-1214
- E-mail: anna.suske@stonybrookmedicine.edu
-
Kontakt:
- Ana Costa, MD
- Telefonnummer: 631-358-6513
- E-mail: ana.costa@stonybrookmedicine.edu
-
Ledende efterforsker:
- Ana Costa, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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.
Tidsramme: 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.
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ana Costa, MD, Stony Brook University
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB2024-00359
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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