Evaluation of the effectiveness of a brief (maximum 15-minute), individualized counseling intervention for reducing preoperative Anxiety

INTERVENTION: Group 1: Following enrollment, participants will complete a total of si Xquestionnaires from the evening before surgery until the morning of the first postoperative day. Estimated duration of data collection: 1 year Arm 1: Intervention Group Patient‐adapted, conversation‐based supportive intervention. The anxiety‐reducing intervention will be administered on the evening before surgery. Group 2: Arm 2: Control Group Standard medical care (without additional intervention) CONDITION: preoperative anxiety PRIMARY OUTCOME: All data will be collected using questionnaires completed by the participants at six different time points, from the day before surgery until the first postoperative day.; ; Primary Outcome; ; Primary Endpoint 1 (Research Question 1):; P1‐a) Level of anesthesia‐related anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (variable: dimensionless APAIS‐Anxiety‐Anesthesia (APAIS‐A‐An) score [range: 2–10]; outcome measure: ? APAIS‐A‐An between the intervention group and the control group at each assessment time point), as well as by the Numeric Rating Scale (NRS) (variable: NRS‐A‐An score [range: 0–10]; outcome measure: ? NRS‐A‐An) between the intervention group and the control group at each assessment time point.; P1‐b) Level of anesthesia‐related anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (variable: dimensionless APAIS‐A‐An score [range: 2–10]; outcome measure: ? APAIS‐A‐An) between baseline and the post‐intervention values reported by the participant at each assessment time point), as well as by the Numeric Rating Scale (NRS) (variable: NRS‐A‐An score [range: 0–10]; outcome measure: ? NRS‐A‐An between baseline and the post‐intervention values reported by the participant at each assessment time point). SECONDARY OUTCOME: Additional Primary Outcome Measures (Primary Endpoints): ; ; Primary Endpoint P2 (Research Question 2): ; Level of anesthesia‐related anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (outcome measure: ? APAIS‐A‐An) and by the Numeric Rating Scale (NRS) (outcome measure: ? NRS‐A‐An) that is perceived by the participant as the minimal clinically important difference (MCID). ; ; Primary Endpoint P3 (Research Question 3): ; Results for the Primary Endpoint P1 in relation to the results for the Primary Endpoint P2: ; Level of anesthesia‐related anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (outcome measure: ? APAIS‐A‐An) and by the Numeric Rating Scale (NRS) (outcome measure: ? NRS‐A‐An) following the intervention in the intervention group versus the control group at each assessment time point (see Primary Endpoint P1), compared with the ? APAIS‐A‐An (variable: APAIS‐A‐An; outcome measure: ? APAIS‐A‐An) and the ? NRS‐A‐An (variable: NRS‐A‐An; outcome measure: ? NRS‐A‐An) that is perceived by the participant as different (see Primary Endpoint P2 / Research Question 2). ; ; Secondary Outcome Measures ; ; S‐I – Corresponding to Primary Outcome Measure P1: ; a) Level of surgery‐related anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (variable: APAIS‐Anxiety‐Surgery (APAIS‐A‐Su); outcome measure: ? APAIS‐A‐Su) and by the Numeric Rating Scale (NRS) (variable: NRS‐A‐Su; outcome measure: ? NRS‐A‐Su) following the intervention compared with the control group, analogous to Primary Outcome Measure P1‐a. ; ; b) Level of total anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (variable: APAIS‐Anxiety‐Total (APAIS‐A‐T); outcome measure: ? APAIS‐A‐T) and by the Numeric Rating Scale (NRS) (variable: NRS‐A‐T; outcome measure: ? NRS‐A‐T) following the intervention compared with the control group, analogous to Primary Outcome Measure P1‐a. ; ; S‐II – Corresponding to Primary Outcome Measure P2: ; a) ? APAIS surgery‐related anxiety (variable: APAIS‐A‐Su; outcome measure: ? APAIS‐A‐Su) and ? NRS surgery‐related anxiety (variable: NRS‐A‐Su; outcome measure: ? NRS‐A‐OP) perceived by the participant as representing a minimal clinically important difference (MCID), analogous to Primary Outcome Measure P2. ; b) ? APAIS total anxiety (variable: APAIS‐A‐T; outcome measure: ? APAIS‐A‐T) and ? NRS total anxiety (variable: NRS‐A‐T; outcome measure: ? NRS‐A‐T) perceived by the participant as representing a minimal clinically important difference (MCID), analogous to Primary Outcome Measure P2. ; ; S‐III – Corresponding to Primary Outcome Measure P3: ; ; Comprison of the results of Secondary Outcome Measure S‐I with the results of Secondary Outcome Measure S‐II ; (to determine whether the intervention effect exceeds the participant‐perceived minimal clinically important difference (MCID)) ; ; a) Level of surgery‐related anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (variable: APAIS‐Anxiety‐Surgery (APAIS‐A‐Su); outcome measure: ? APAIS‐A‐Su) and by the Numeric Rating Scale (NRS) (variable: NRS‐A‐Su; outcome measure: ? NRS‐A‐Su) following the intervention in the intervention group versus the control group, compared with the ? APAIS‐A‐S (variable: APAIS‐A‐Su; outcome measure: ? APAIS‐A‐Su) and ? NRS‐A‐Su values perceived by the participant as representing a minimal clinically important difference (MCID), (analogous to Primary Outcome Measure P3) to determine whether the intervention effect exceeds the participant‐perceived minimal clinically important difference (MCID)) ; ; b) Level of total anxiety as assessed by the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (variable: APAIS‐A‐T; outcome measure: ? APAIS‐A‐T) and by the Numeric Rating Scale (NRS) (variable: NRS‐A‐T; outcome measure: ? NRS‐A‐T) following the intervention in the intervention group versus the control group, compared with the ? APAIS‐A‐T (variable: APAIS‐A‐T; outcome measure: ? APAIS‐A‐T) and ? NRS‐A‐T values perceived by the participant as representing a minimal clinically important difference (MCID), (analogous to Primary Outcome Measure H3), to determine whether the intervention effect exceeds the participant‐perceived minimal clinically important difference (MCID)). ; ; S‐IV ; a) Level of pain at rest and during movement as assessed by the Numeric Rating Scale (NRS) in the surgical site (variable: NRS‐Pain‐Surgical site (NRS‐P‐Su); outcome measure: ? NRS‐P‐Su) and outside the surgical site (variable: NRS‐Pain‐Non‐surgical site (NRS‐P‐NonSu); outcome measure: ? NRS‐P‐NonSu) following the intervention in the intervention group versus the control group. ; ; S‐V ; Frequency of the desire for anxiolytic premedication (if needed) from the evening before surgery until transfer to the operating room: control group versus intervention group. ; ; S‐VI ; Influence of independent variables (e.g., age, sex, and educational level) on the effect of the intervention, as assessed by the dependent variables of anesthesia‐related anxiety, surgery‐related anxiety, and total anxiety measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (variables: APAIS‐A‐An, APAIS‐A‐Su, APAIS‐A‐T) and the Numeric Rating Scale (NRS) (variables: NRS‐A‐An, NRS‐A‐Su, NRS‐A‐T). ; ; S‐VII ; Identification of variables that have a significant influence on the presence of preoperative anxiety, the degree of distress caused by preoperative anxiety, and the resulting desire for support (dependent outcome variables: anesthesia‐related anxiety, surgery‐related anxiety, and total anxiety, as assessed by the Amsterdam Preoperative Anxiety and Information Scale [APAIS] [variables: APAIS‐A‐An, APAIS‐A‐Su, APAIS‐A‐T] and the Numeric Rating Scale [NRS] [variables: NRS‐A‐An, NRS‐A‐Su, NRS‐A‐T]), as well as the magnitude of their influence on these outcome variables. Outcome parameter: odds ratio (OR). ; ; S‐VIII ; Identification of variables (specific fears) underlying the four dimensions of anxiety—(1) anesthesia‐related anxiety, (2) surgery‐related anxiety, (3) total preoperative anxiety INCLUSION CRITERIA: Adult patients: ‐ undergoing elective surgery under general anesthesia or a combination of general and regional anesthesia; ‐ who are not scheduled to undergo surgery on the same day as the surgical and anesthetic informed consent process; ‐ who are admitted to the hospital no later than the day before surgery; ‐ who report a desire for a counseling‐supported assistance due to preoperative anxiety.