Structured Information During the Intensive Care Unit Stay

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay

Conditions
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Anxiety

Intervention / Treatment
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* Behavioral: Structured information
* Other: Unspecific conversation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Structured information | Behavioral: Structured information<br>* Participants will receive structured information about their ICU-stay and course of therapy and care. They get information about procedures, sensory impressions and coping strategies. The intervention will last about 10 to 15 minutes depending on the state of the participant.<br>|
| Sham Comparator: 2<br>Unspecific conversation | Other: Unspecific conversation<br>* Participants will receive a short conversation with the study personnel. This conversation will last about 10 to 15 minutes. No specific informations will be given about procedures, sensory impressions or coping strategies. Control intervention is designed to control for personal attention and care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reported anxiety |  | First three days on ICU and/or within 24 hours after ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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information programme, anxiety reduction, multicenter trial, intensive care, critical care