Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program
This study is currently recruiting participants.
Verified by Philipps University Marburg Medical Center, September 2005
Sponsors and Collaborators: Philipps University Marburg Medical Center
Pflegeverbund Mitte-Süd
Stabstelle Pflegeforschung
Institut für Theoretische Chirurgie
Klinik für Herzchirurgie
Klinik für VTG-Chirurgie
Information provided by: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00151554
  Purpose

According to current evidence and psychological theorizing, the provision of information seems to be a promising way to reduce the anxiety of patients that is related to their scheduled ICU stay. An ICU-specific information program will be investigated in a randomized controlled clinical trial involving 120 patients undergoing elective open heart surgery and 20 patients undergoing abdominal surgery. It is expected that the patients in the test group will experience less anxiety and ICU related discomfort than patients in the control group.


Condition Intervention Phase
Heart Diseases
Behavioral: ICU-specific information program
Phase III

MedlinePlus related topics: Anxiety Heart Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind, Active Control, Single Group Assignment
Official Title: Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Patient self-reported anxiety
  • ICU related discomfort

Secondary Outcome Measures:
  • Objective health status parameters
  • Overall satisfaction with care
  • Quality of life

Study Start Date: February 2005
Estimated Study Completion Date: December 2006
Detailed Description:

Objective: According to current evidence and psychological theorizing the provision of information seems to be a promising way to reduce anxiety of patients. In the case of surgical patients, admission to the intensive care unit (ICU) is strongly associated with uncertainty, unpredictability and anxiety for the patient. Thus, ICU-specific information could have a high clinical impact. For this reason this study will evaluate the efficacy of an ICU-specific information program for patients who undergo elective cardiac, abdominal or thoracic surgery and are scheduled for ICU stay.

Methods: The trial is designed as a prospective randomized controlled trial including an intervention and a control group. The control group receives the standard preparation currently conducted by surgeons and anesthesists. The intervention group additionally receives a standardized information program with specific procedural, sensory and coping information about the ICU. In addition the moderating effect of certain personality characteristics (need for cognition, high trait anxiety) will be investigated to identify groups of patients who benefit most from the information program.

Expected Results: A clinically relevant difference in anxiety and unpleasant experiences related to the ICU is expected after discharge from the ICU. Power calculation (alpha = 0.05; beta = 0.20; delta = 8.50 score points) resulted in a required sample size of N = 120 cardiac surgical patients (n = 60 vs. n = 60). Furthermore, N = 20 abdominal or thoracic surgical patients will be recruited (n = 10 vs. n = 10).

Conclusion: The proposed study promises to strengthen evidence on the effects of a specific, concise information program and thus should contribute to evidence based nursing (EBN).

  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
  • Informed consent

Exclusion Criteria:

  • Elective surgery without ICU stay
  • Informed consent denied
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151554

Contacts
Contact: Steffen Fleischer, Dipl.-PGW +49 6421 286 66759 steffen.fleischer@staff.uni-marburg.de
Contact: Berg Almuth, Dipl.-PGW +49 6421 286 66759 almuth.berg@staff.uni-marburg.de

Locations
Germany, Hessen
University Hospital Marburg Recruiting
Marburg, Hessen, Germany, 35033
Contact: Thomas Neubert, PhD     +49 6421 286 3285     neutert@staff.uni-marburg.de    
Principal Investigator: Thomas Neubert, PhD            
Sponsors and Collaborators
Philipps University Marburg Medical Center
Pflegeverbund Mitte-Süd
Stabstelle Pflegeforschung
Institut für Theoretische Chirurgie
Klinik für Herzchirurgie
Klinik für VTG-Chirurgie
Investigators
Principal Investigator: Thomas Neubert, PhD Stabstelle Pflegeforschung, Universitätsklinikum Marburg
  More Information

Study ID Numbers: PflegeverbundMarburg2, BMBF grant 01GT0303
Study First Received: September 7, 2005
Last Updated: July 17, 2007
ClinicalTrials.gov Identifier: NCT00151554  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Philipps University Marburg Medical Center:
Anxiety
Intensive Care Unit (ICU)
Preoperative Information
Randomized Controlled Trial (RCT)
Chronic heart disease

Study placed in the following topic categories:
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009