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Structured Information During the Intensive Care Unit Stay

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00764933
First received: October 1, 2008
Last updated: June 1, 2010
Last verified: January 2010
History of Changes
  Purpose

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.


Condition Intervention
Anxiety
 Behavioral: Structured information
Other: Unspecific conversation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Multi Center Study to Evaluate the Efficacy of a Structured Information Program During ICU Stay

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Patient self-reported anxiety [ Time Frame: First three days on ICU and/or within 24 hours after ICU discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Confusion Assessment Method for the ICU (CAM-ICU) [ Time Frame: Within first three days on ICU ] [ Designated as safety issue: No ]
  • Patient self reported health-related quality of life [ Time Frame: 3 months after discharge from hospital ] [ Designated as safety issue: No ]

Enrollment: 211
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764933

Locations
Germany
Sana Herzchirurgische Klinik Stuttgart GmbH
Stuttgart, BW, Germany
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
Institut für Gesundheits- und Pflegewissenschaft, Universitätsklinik für Anästhesiologie und operative Intensivmedizin, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
Halle, SAN, Germany, 06097
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
German Federal Ministry of Education and Research
  More Information

No publications provided by Martin-Luther-Universität Halle-Wittenberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Prof. Dr. phil habil Johann Behrens, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00764933     History of Changes
Other Study ID Numbers: PfVMS-T4
Study First Received: October 1, 2008
Last Updated: June 1, 2010
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
information programme
anxiety reduction
multicenter trial
intensive care
critical care

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 13, 2013