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"Preoperative Stress Reduction Using Two Cognitive Engagement Interventions During Immediate Preoperative Waiting: A Randomized Controlled Trial"

"Preoperative Stress Reduction Using Two Cognitive Engagement Interventions During Immediate Preoperative Waiting: A Randomized Controlled Trial"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040609
Enrollment
300
Registered
2026-07-03
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Preoperative Anxiety and Stress

Interventions

Group 1: Controllgroup After informed consent, adult surgical patients with an expected preoperative waiting time of at least 15 minutes undergo a baseline assessment (T1) of subjective stress and anx

Sponsors

Universitätsklinikum Giessen und Marburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Scheduled surgical procedure with an anticipated preoperative waiting time of at least 15 minutes Presence in the preoperative waiting area (OAE) or anesthesia induction area Capacity to provide informed consent Written or otherwise documented informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Ophthalmologic patients with visual impairment that would preclude meaningful use of the distraction tools Patients classified as ASA physical status IV or higher Patients with dementia, relevant cognitive impairment, intellectual disability, or legal guardianship Refusal to participate or lack of informed consent Explicit request for pharmacological anxiolysis (e.g., midazolam) before initiation of the intervention; such patients will receive standard clinical care but will not be enrolled in the study

Design outcomes

Primary

MeasureTime frame
Change in subjective stress and anxiety levels between T1 (baseline) and T2 (immediately before induction of anesthesia), measured using validated scales (VAS for stress and, where applicable, APAIS for anxiety), and compared across the three study groups (control group vs. intervention group A vs. intervention group B).

Secondary

MeasureTime frame
Comparison of the effect sizes of the two interventions (cognitive distraction booklet vs. Perplexus®) with regard to reductions in preoperative stress and anxiety. Patient-reported acceptability and perceived usefulness of the interventions, assessed on the first postoperative day (T3). Feasibility and practicality of the interventions in routine clinical care, including usability, duration of use, and required staff involvement. Evaluation of design and content characteristics of the interventions, with particular focus on the cognitive distraction booklet. Descriptive analysis of study drop-outs and the reasons for discontinuation or non-completion.

Countries

Germany

Contacts

Public ContactFelix Schmitt

Universitätsklinikum Giessen und Marburg

felix.schmitt@uk-gm.de064215865981

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026