A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 211
- Locations
- 3
- Primary Endpoint
- Patient self-reported anxiety
Study Overview
Brief Summary
The purpose of this study is to test whether a structured information program at the beginning of the ICU-stay is effective to reduce ICU related anxiety and discomfort.
Detailed Description
The trial is designed as a prospective multicenter randomized controlled trial including an intervention and a control group. The control group receives an unspecific conversation. The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU. Anxiety will be measured with a VAS during ICU stay and with a questionnaire after ICU discharge.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective open heart or abdominal surgery including scheduled ICU stay
- •Heart or abdominal surgery or internal patients with non-scheduled ICU stay
- •Informed consent
Exclusion Criteria
- •Reduced sensual perception
- •Cognitive impairment
- •Not able to answer a questionnaire (e.g. illiterate)
- •Lying in the same room with another patient already included
Arms & Interventions
1
Structured information
Intervention: Structured information (Behavioral)
2
Unspecific conversation
Intervention: Unspecific conversation (Other)
Outcomes
Primary Outcomes
Patient self-reported anxiety
Time Frame: First three days on ICU and/or within 24 hours after ICU discharge
Secondary Outcomes
- Confusion Assessment Method for the ICU (CAM-ICU)(Within first three days on ICU)
- Patient self reported health-related quality of life(3 months after discharge from hospital)