Preoperative anxiety: Assessment of the effectiveness of an individualized intervention to reduce preoperative anxiety and determination of the minimal clinically relevant difference in intensities of preoperative anxiety on a measuring scale for intensity of anxiety in combination with the investigation of the moderating effect of patient variables on the effect of the individualized intervention to reduce anxiety, the identification of risk factors and specific fears of preoperative anxiety including the anxiety related to surgery and anesthesia and the examination of the course of the anxiety level.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00024416

Enrollment

195

Registered

2021-02-16

Start date

2021-03-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PREOPERATIVE ANXIETY F41.9

Interventions

Group 1: Individual, patient-adapted intervention on the basis of additional information through the use of films and discussions. After the patients have been included, they will fill out a total of

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult patients who undergo elective surgery under general anesthesia or a combination of general and regional anesthesia Additionallyf for questions 1 to 4: Patients who are not operated on on the day of the preanesthetic and preoperative assessment, who are admitted to hospital no later than the day before the operation, aqd who report the need for information-based support due to preoperative anxiety.

Exclusion criteria

Exclusion criteria: - Patients who do not have sufficient knowledge of the German language to be able to complete the questionnaire. - Patients who are unable to process the questionnaire or give their informed consent due to a mental illness. - Restrictions in hearing or eyesight that prevent the viewing of an information film and listening to explanations doctors may give inreply to questions patients might have.

Design outcomes

Primary

Measure	Time frame
Main outcome parameter: concerning question 1: a) Level of anesthesia anxiety according to APAIS (variable: dimensionless APAIS-A-An value (2 to 10) and as the target parameter the ? APAIS-A-An between the intervention group and control group at the various times following the intervention) and NRS (variable: NRS-A -An value (scale 0 - 10) and as the target parameter ? NRS-A-An between the intervention group and control group at the various times following the intervention) b) Level of anesthesia anxiety according to APAIS (variable: dimensionless APAIS-A-An value (2 to 10) and as the target parameter the ? APAIS-A-An between the initial value (baseline) and the various scores after the intervention) and NRS (variable: NRS-A-An (scale 0-10) and as target parameter ? NRS-A-An between the initial value (baseline) and the various scores after the intervention) concerning question 2: a) Level of anesthesia anxiety according to APAIS (variable: ? APAIS-A-An) and NRS (? NRS-A-An) after the intervention in the intervention group versus the control group at the various interview times compared to ? APAIS anesthesia anxiety (variable: APAIS -A-An; target parameter: ? APAIS-A-An) and ? NRS (variable NRS-A-An; target parameter: ? NRS-A-An), which is perceived as different by the patient. b) Level of anesthesia anxiety according to APAIS (variable: APAIS-A-An, target parameter: ? APAIS-A-An) and NRS (variable: NRS-A-An, target parameter: ? NRS-A-An) before versus after the intervention at the various interview times within the individual groups compared to ? APAIS-Anesthesia anxiety (? APAIS-A-An) and ? NRS (variable NRS-A-An; target parameter: ? NRS-A-An), which is perceived as diferent by the patient. concerning question 3: a) Level of anesthesia anxiety according to APAIS (variable: ? APAIS-A-An) and NRS (? NRS-A-An) after the intervention in the intervention group versus the control group at the various interview times compared to ? APAIS anesthesia anxiety (variable: A	—

Measure

Time frame

Main outcome parameter: concerning question 1: a) Level of anesthesia anxiety according to APAIS (variable: dimensionless APAIS-A-An value (2 to 10) and as the target parameter the ? APAIS-A-An between the intervention group and control group at the various times following the intervention) and NRS (variable: NRS-A -An value (scale 0 - 10) and as the target parameter ? NRS-A-An between the intervention group and control group at the various times following the intervention) b) Level of anesthesia anxiety according to APAIS (variable: dimensionless APAIS-A-An value (2 to 10) and as the target parameter the ? APAIS-A-An between the initial value (baseline) and the various scores after the intervention) and NRS (variable: NRS-A-An (scale 0-10) and as target parameter ? NRS-A-An between the initial value (baseline) and the various scores after the intervention) concerning question 2: a) Level of anesthesia anxiety according to APAIS (variable: ? APAIS-A-An) and NRS (? NRS-A-An) after the intervention in the intervention group versus the control group at the various interview times compared to ? APAIS anesthesia anxiety (variable: APAIS -A-An; target parameter: ? APAIS-A-An) and ? NRS (variable NRS-A-An; target parameter: ? NRS-A-An), which is perceived as different by the patient. b) Level of anesthesia anxiety according to APAIS (variable: APAIS-A-An, target parameter: ? APAIS-A-An) and NRS (variable: NRS-A-An, target parameter: ? NRS-A-An) before versus after the intervention at the various interview times within the individual groups compared to ? APAIS-Anesthesia anxiety (? APAIS-A-An) and ? NRS (variable NRS-A-An; target parameter: ? NRS-A-An), which is perceived as diferent by the patient. concerning question 3: a) Level of anesthesia anxiety according to APAIS (variable: ? APAIS-A-An) and NRS (? NRS-A-An) after the intervention in the intervention group versus the control group at the various interview times compared to ? APAIS anesthesia anxiety (variable: A

—

Secondary

Measure	Time frame
I - concerning primary outcome 1: a) Level of overall anxiety (total anxiety) according to APAIS (variable: APAIS-A-T; target criterion: ? APAIS-A-T) and NRS (variable: NRS-A-T; target criterion: ? NRS-A-T) after the intervention compared to the control group in analogy to the main outcome criterion of 1a. b) Level of surgery anxiety according to APAIS (variable: APAIS-A-OP; target criterion: ? APAIS-A-OP) and NRS (variable: NRS-A-OP; target criterion: ? NRS-A-OP) after the intervention in comparison with the control group in analogy to the main outcome criterion of 1a. c) Level of overall anxiety (total fear) according to APAIS (variable: APAIS-A-T; target criterion: ? APAIS-A-T) and NRS (variable: NRS-A-T; target criterion: ? NRS-AT) before versus after the intervention in analogy to the main outcome criterion of Ib. d) Level of surgery anxiety according to APAIS (variable: APAIS-A-OP; target criterion: ? APAIS-A-OP) and NRS (variable: NRS-A-OP; target criterion: ? NRS-A-OP) before versus after Intervention in analogy to the main outcome criterion of Ib. II - concerning primary outcome 2: a) ? APAIS total anxiety (variable: APAIS-AT; target criterion: ? APAIS-A-T)), and NRS total anxiety (variable: NRS-A-T; target criterion: ? APAIS-A-T), that is perceived as different by the patient (in analogy to main outcome criteria of 2 a and 2b). b) ? APAIS surgery anxiety (variable: APAIS-A-OP; target criterion: ? APAIS-A-OP), and NRS surgery anxiety (variable: NRS-A-OP; target criterion: ? NRS-A-OP), that is perceived as different by the patient (in analogy to the main outcome criteria of 2a and 2b). III - concerning primary outcome 3: a) Level of overall anxiety according to APAIS (variable: APAIS-A-T; target criterion: ? APAIS-AT) and NRS (variable: NRS-A-T; target criterion: ? NRS-A-T) after the intervention versus control group compared to ? APAIS overall anxiety (Variable: APAIS-A-T; target criterion: ? APAIS-AT) and NRS total anxiety, which is perce	—

Measure

Time frame

I - concerning primary outcome 1: a) Level of overall anxiety (total anxiety) according to APAIS (variable: APAIS-A-T; target criterion: ? APAIS-A-T) and NRS (variable: NRS-A-T; target criterion: ? NRS-A-T) after the intervention compared to the control group in analogy to the main outcome criterion of 1a. b) Level of surgery anxiety according to APAIS (variable: APAIS-A-OP; target criterion: ? APAIS-A-OP) and NRS (variable: NRS-A-OP; target criterion: ? NRS-A-OP) after the intervention in comparison with the control group in analogy to the main outcome criterion of 1a. c) Level of overall anxiety (total fear) according to APAIS (variable: APAIS-A-T; target criterion: ? APAIS-A-T) and NRS (variable: NRS-A-T; target criterion: ? NRS-AT) before versus after the intervention in analogy to the main outcome criterion of Ib. d) Level of surgery anxiety according to APAIS (variable: APAIS-A-OP; target criterion: ? APAIS-A-OP) and NRS (variable: NRS-A-OP; target criterion: ? NRS-A-OP) before versus after Intervention in analogy to the main outcome criterion of Ib. II - concerning primary outcome 2: a) ? APAIS total anxiety (variable: APAIS-AT; target criterion: ? APAIS-A-T)), and NRS total anxiety (variable: NRS-A-T; target criterion: ? APAIS-A-T), that is perceived as different by the patient (in analogy to main outcome criteria of 2 a and 2b). b) ? APAIS surgery anxiety (variable: APAIS-A-OP; target criterion: ? APAIS-A-OP), and NRS surgery anxiety (variable: NRS-A-OP; target criterion: ? NRS-A-OP), that is perceived as different by the patient (in analogy to the main outcome criteria of 2a and 2b). III - concerning primary outcome 3: a) Level of overall anxiety according to APAIS (variable: APAIS-A-T; target criterion: ? APAIS-AT) and NRS (variable: NRS-A-T; target criterion: ? NRS-A-T) after the intervention versus control group compared to ? APAIS overall anxiety (Variable: APAIS-A-T; target criterion: ? APAIS-AT) and NRS total anxiety, which is perce

—

Countries

Germany

Contacts

Public ContactDirk Rüsch

UKGM Standort Marburg

ruesch@med.uni-marburg.de+49 6421 5861386

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026