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PATE-Trial - Perioperative Anxiolysis and Treatment Expectation

PATE-Trial - Perioperative Anxiolysis and Treatment Expectation - PATE-Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00033221
Enrollment
144
Registered
2023-12-22
Start date
2024-02-28
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Perioperative anxiety, treatment expectations, postoperative pain

Interventions

Group 1: Intervention open-label-placebo (OLP) Preoperative Administration of Open-Label-Placebo to decrease preoperative Anxiety. Group 2: Intervention OLP + learning via Video (OLP + V) Following

Sponsors

Universitätsklinikum Essen Klinik für Anästhesiologie und Intensivmedizin
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: - Fluent German - Ability to cooperate with the study team and fulfill the requirements of the entire study - (written) consent to the surgery and to the study - ASA I-III

Exclusion criteria

Exclusion criteria: - German language skills that are not sufficient for understanding the study - Refusal to participate - Acute serious anesthesia-related complications - Acute serious mental illness - Expected difficult airway - Severe peri-/postoperative complications - Rare galactose intolerance, lactase deficiency, glucose-galactose malabsorption

Design outcomes

Primary

MeasureTime frame
Preoperative Anxiety (NRS, APAIS = Amsterdam Preoperative Anxiety and Information Scale)

Secondary

MeasureTime frame
- Postoperative visceral and somatic pain (VAS, NRS) - Treatment expectation (GEEE, SETS) - Analgesic consumption - Warmth and competency - Duration of anesthesia, length of stay in the recovery room and in the hospital - State-Trait-Anxiety Inventory (STAI)

Countries

Germany

Contacts

Public ContactJana Aulenkamp

Universitätsklinikum Essen Klinik für Anästhesiologie und Intensivmedizin

jana.aulenkamp@uk-essen.de0201-723 86219

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 6, 2026