Structured Information During the Intensive Care Unit Stay

June 1, 2010 updated by: Martin-Luther-Universität Halle-Wittenberg

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • BW
      • Stuttgart, BW, Germany
        • Sana Herzchirurgische Klinik Stuttgart GmbH
    • HES
      • Marburg, HES, Germany
        • Universitätsklinikum Gießen und Marburg, Kooperationsstudien Pflegedienst/Ärztlicher Dienst, Klinik für Visceral-, Thorax- und Gefäßchirurgie, Klinik für Herz- und thorakale Gefäßchirurgie, Standort Marburg
    • SAN
      • Halle, SAN, Germany, 06097
        • Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Structured information
Behavioral: Structured information
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.
Sham Comparator: 2
Unspecific conversation
Other: Unspecific conversation
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Confusion Assessment Method for the ICU (CAM-ICU)
Time Frame: Within first three days on ICU
Within first three days on ICU
Patient self reported health-related quality of life
Time Frame: 3 months after discharge from hospital
3 months after discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

German Federal Ministry of Education and Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

October 1, 2008

First Submitted That Met QC Criteria

October 1, 2008

First Posted (Estimate)

October 2, 2008

Study Record Updates

Last Update Posted (Estimate)

June 3, 2010

Last Update Submitted That Met QC Criteria

June 1, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PfVMS-T4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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