title: Effect of the informed consent process on anxiety and comprehension of patients undergoing esophageal and gastrointestinal surgery.
abstract: OBJECTIVE
  This study seeks to evaluate the level of anxiety, recall, and comprehension of the provided information in patients undergoing esophageal and gastrointestinal surgery.
  
  
  METHODS
  Sixty-one patients without cognitive disorders entered a prospective study designed to assess the effect of a surgical informed consent process. The written informed consent was administered to all patients and was supported by a verbal explanation and a schematic drawing of the operation. The State Trait Anxiety Inventory test was used to assess state anxiety and tract anxiety. The test was repeated after the informed consent process. A disease-specific feedback questionnaire was subsequently administered to assess the actual comprehension of the provided information.
  
  
  RESULTS
  A significant decrease of the state anxiety scores was documented in most patients (p < 0.001). This effect was more evident in the elderly (p = 0.021) and in those who used Internet as a previous source of information (p = 0.032). The mean correct exact answer rate on the disease-specific questionnaire was 76% (IQ range 66.7-85%). No statistically significant relationship was found between the rate of correct answers and the state anxiety scores.
  
  
  CONCLUSIONS
  An exhaustive surgical informed consent process was effective in providing comprehension and decreasing anxiety in patients who are candidates to minimally invasive esophageal and gastrointestinal surgical procedures.
authors.affiliation: Clinical Psychology Unit IRCCS Policlinico San Donato, School of Medicine, University of Milano, Milan, Italy.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Betti
authors.forename: Andrea
authors.initials: A
authors.lastname: Sironi
authors.forename: Greta
authors.initials: G
authors.lastname: Saino
authors.forename: Cristian
authors.initials: C
authors.lastname: Ricci
authors.forename: Luigi
authors.initials: L
authors.lastname: Bonavina
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001007:Anxiety / Q000523:psychology*; D002277:Carcinoma / Q000601:surgery*; D032882:Comprehension; D004938:Esophageal Neoplasms / Q000601:surgery*; D005260:Female; D005767:Gastrointestinal Diseases / Q000601:surgery*; D006801:Humans; D007258:Informed Consent / Q000523:psychology*; D008297:Male; D011939:Mental Recall; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000523:psychology; D011446:Prospective Studies; D011581:Psychological Tests; D018709:Statistics, Nonparametric