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

Официальное название

Fear and Anesthesia: How Anxiety and Fear in Anesthesia-Naïve Patients Changes From Preop to Postop

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Survey using a questionnaire.
  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.

Первичные конечные точки

• Differences in anxiety scale scores pre- and post-operatively in anesthesia-naïve patients [Срок оценки: From enrollment until 7 days (+/-72 hours) post-operative]

Вторичные конечные точки (2)

• 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. [Срок оценки: 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. [Срок оценки: From enrollment until 7 days (+/-71 hours) post-operative]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 1 центр

• Stony Brook University Hospital — Stony Brook

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 28217078

Идентификаторы

NCT: NCT07559461 · IRB2024-00359

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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