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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00151554
Enrollment
140
Registered
2005-09-09
Start date
2005-02-28
Completion date
2006-12-31
Last updated
2010-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Anxiety, Intensive Care Unit (ICU), Preoperative Information, Randomized Controlled Trial (RCT), Chronic heart disease

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).

Interventions

BEHAVIORALICU-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.

Sponsors

Pflegeverbund Mitte-Süd
CollaboratorUNKNOWN
Stabstelle Pflegeforschung
CollaboratorUNKNOWN
Institut für Theoretische Chirurgie
CollaboratorUNKNOWN
Klinik für Herzchirurgie
CollaboratorUNKNOWN
Klinik für VTG-Chirurgie
CollaboratorUNKNOWN
Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Elective surgery without ICU stay * Informed consent denied

Design outcomes

Primary

MeasureTime frame
Patient self-reported anxietyafter admission on standard ward
ICU related discomfortafter admission on standard ward

Secondary

MeasureTime frame
Objective health status parameterspostoperative phase of hospital stay
Overall satisfaction with care3 months after discharge
Quality of life3 months after discharge

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026