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NCT Number: NCT00151554

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

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.

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Key information

Conditions

Heart Diseases Anxiety Disorders Cardiovascular Diseases Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Marburg

Marburg, Hesse, 35033, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Elective surgery without ICU stay
  • Informed consent denied

Treatment and study plan

ICU-specific information program

Behavioral

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.

Primary outcomes

  1. Patient self-reported anxiety

    Time frame: after admission on standard ward

  2. ICU related discomfort

    Time frame: after admission on standard ward

Secondary outcomes

  1. Objective health status parameters

    Time frame: postoperative phase of hospital stay

  2. Overall satisfaction with care

    Time frame: 3 months after discharge

  3. Quality of life

    Time frame: 3 months after discharge

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Collaborators

  • Institut für Theoretische Chirurgie
  • Klinik für Herzchirurgie
  • Klinik für VTG-Chirurgie
  • Pflegeverbund Mitte-Süd
  • Stabstelle Pflegeforschung

Registry information

Official study title

Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
Jul 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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