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

Not Applicable

Completed

• Conditions: Heart Diseases
• Interventions: Behavioral: ICU-specific information program

• Registration Number: NCT00151554
• Lead Sponsor: Philipps University Marburg Medical Center

Brief Summary

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.

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).

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2006-09
• Study Completion: 2006-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-28
• Last Update Posted: 2010-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

• Elective surgery without ICU stay
• Informed consent denied

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	ICU-specific information program	-

Primary Outcome Measures

Name	Time	Method
Patient self-reported anxiety	after admission on standard ward
ICU related discomfort	after admission on standard ward

Secondary Outcome Measures

Name	Time	Method
Objective health status parameters	postoperative phase of hospital stay
Overall satisfaction with care	3 months after discharge
Quality of life	3 months after discharge

Trial Locations

Locations (1)

University Hospital Marburg; 🇩🇪 Marburg, Hessen, Germany