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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00151554
First received: September 7, 2005
Last updated: July 28, 2010
Last verified: July 2010
  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
Heart Diseases
Behavioral: ICU-specific information program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Patient self-reported anxiety [ Time Frame: after admission on standard ward ] [ Designated as safety issue: No ]
  • ICU related discomfort [ Time Frame: after admission on standard ward ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective health status parameters [ Time Frame: postoperative phase of hospital stay ] [ Designated as safety issue: No ]
  • Overall satisfaction with care [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: February 2005
Study Completion Date: December 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Experimental: Intervention group 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151554

Locations
Germany
University Hospital Marburg
Marburg, Hessen, Germany, 35033
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

Publications:
Responsible Party: Dr. Thomas R. Neubert, Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00151554     History of Changes
Other Study ID Numbers: PflegeverbundMarburg2, BMBF grant 01GT0303
Study First Received: September 7, 2005
Last Updated: July 28, 2010
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

Additional relevant MeSH terms:
Anxiety Disorders
Heart Diseases
Mental Disorders
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014