- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Anna Suske
- Telefonnummer: 631-638-1214
- E-Mail: anna.suske@stonybrookmedicine.edu
Studienorte
-
-
New York
-
Stony Brook, New York, Vereinigte Staaten, 11794
- Rekrutierung
- 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
-
Hauptermittler:
- Ana Costa, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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.
Zeitfenster: 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.
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Ana Costa, MD, Stony Brook University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB2024-00359
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .