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Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00151554
First Posted: September 9, 2005
Last Update Posted: July 29, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Pflegeverbund Mitte-Süd
Stabstelle Pflegeforschung
Institut für Theoretische Chirurgie
Klinik für Herzchirurgie
Klinik für VTG-Chirurgie
Information provided by:
Philipps University Marburg Medical Center
September 7, 2005
September 9, 2005
July 29, 2010
February 2005
September 2006   (Final data collection date for primary outcome measure)
  • Patient self-reported anxiety [ Time Frame: after admission on standard ward ]
  • ICU related discomfort [ Time Frame: after admission on standard ward ]
  • Patient self-reported anxiety
  • ICU related discomfort
Complete list of historical versions of study NCT00151554 on ClinicalTrials.gov Archive Site
  • Objective health status parameters [ Time Frame: postoperative phase of hospital stay ]
  • Overall satisfaction with care [ Time Frame: 3 months after discharge ]
  • Quality of life [ Time Frame: 3 months after discharge ]
  • Objective health status parameters
  • Overall satisfaction with care
  • Quality of life
Not Provided
Not Provided
 
Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program
Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial
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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Heart Diseases
Behavioral: ICU-specific information program
The intervention group receives a standardized information program with specific procedural, sensory and coping information about the ICU in addition to standard information given by surgeons and anesthetists.
  • No Intervention: Control group
  • Experimental: Intervention group
    Intervention: Behavioral: ICU-specific information program
Berg A, Fleischer S, Koller M, Neubert TR. Preoperative information for ICU patients to reduce anxiety during and after the ICU-stay: protocol of a randomized controlled trial [NCT00151554]. BMC Nurs. 2006 Mar 8;5:4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2006
September 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective open heart or abdominal surgery including scheduled ICU stay
  • Informed consent

Exclusion Criteria:

  • Elective surgery without ICU stay
  • Informed consent denied
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00151554
PflegeverbundMarburg2
BMBF grant 01GT0303
Not Provided
Not Provided
Not Provided
Dr. Thomas R. Neubert, Philipps University Marburg Medical Center
Philipps University Marburg Medical Center
  • Pflegeverbund Mitte-Süd
  • Stabstelle Pflegeforschung
  • Institut für Theoretische Chirurgie
  • Klinik für Herzchirurgie
  • Klinik für VTG-Chirurgie
Principal Investigator: Thomas Neubert, PhD Stabstelle Pflegeforschung, Universitätsklinikum Marburg
Philipps University Marburg Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP