Clinical trial NCT00151554: Reducing Intensive Care Unit (ICU) Related Anxiety Through a Structured Information Program
Official title: Reducing ICU Related Anxiety Through a Structured Information Program. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: Anxiety
Intensive Care Unit (ICU)
Preoperative Information
Randomized Controlled Trial (RCT)
Chronic heart disease
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
Collaborators: name: Pflegeverbund Mitte-Süd
name: Stabstelle Pflegeforschung
name: Institut für Theoretische Chirurgie
name: Klinik für Herzchirurgie
name: Klinik für VTG-Chirurgie
First posted: 2005-09-09
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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).

Eligibility 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

Primary outcomes:
measure: Patient self-reported anxiety
timeFrame: after admission on standard ward
measure: ICU related discomfort
timeFrame: after admission on standard ward
Secondary outcomes:
measure: Objective health status parameters
timeFrame: postoperative phase of hospital stay
measure: Overall satisfaction with care
timeFrame: 3 months after discharge
measure: Quality of life
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: University Hospital Marburg
state: Hessen
Study officials:
affiliation: Stabstelle Pflegeforschung, Universitätsklinikum Marburg
name: Thomas Neubert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/1472-6955-5-4.