Structured Information During the Intensive Care Unit Stay

Not Applicable

Completed

• Conditions: Anxiety
• Interventions: Behavioral: Structured information; Other: Unspecific conversation

• Registration Number: NCT00764933
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-10-01
• Study First Submitted QC: 2008-10-01
• Study First Posted: 2008-10-02
• Primary Completion: 2009-12
• Status Verified: 2010-01
• Study Completion: 2010-03
• Last Update Submitted: 2010-06-01
• Last Update Posted: 2010-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 211

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Structured information	Structured information
2	Unspecific conversation	Unspecific conversation

Primary Outcome Measures

Name	Time	Method
Patient self-reported anxiety	First three days on ICU and/or within 24 hours after ICU discharge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Universitätsklinikum Gießen und Marburg, Kooperationsstudien Pflegedienst/Ärztlicher Dienst, Klinik für Visceral-, Thorax- und Gefäßchirurgie, Klinik für Herz- und thorakale Gefäßchirurgie, Standort Marburg; 🇩🇪 Marburg, HES, Germany

Sana Herzchirurgische Klinik Stuttgart GmbH; 🇩🇪 Stuttgart, BW, Germany

Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg; 🇩🇪 Halle, SAN, Germany